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Frogster
Posted on: Dec 13 2019, 10:14 PM


Group: Member
Posts: 621

The analysts at major brokers will be very reluctant to initiate coverage on a stock that won't provide access to management or even answer basic questions. We know from Sphene this is the approach they have taken to enquiries from actively interested parties. Some might do it, but it would be very reluctantly.

I think this approach is also a major factor in why we have only limited institutional ownership. The likes of Fidelity and Capital Intl direct their commission flows in part to the brokers who can provide best management access. No management access/non responsive IR will normally mean no investment.

This approach from CUV is a policy. They don't want scrutiny from anyone. They want well behaved, quiet capital that doesn't challenge them.

I don't think they'll change with this management team on board.
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Frogster
Posted on: Dec 4 2019, 10:06 PM


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Posts: 621

We know he was an analyst. Do we know he was successful? I've known many who weren't.
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Frogster
Posted on: Dec 3 2019, 03:02 PM


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Posts: 621

Does anyone else think the strongest argument right now for PW to come up with a credible execution gameplan for achieving US roll out, vitiligo and DNA repair commercialisation is just to stop the bickering on this board? Hell, if he can do that I'd probably even vote him a few more shares!
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Frogster
Posted on: Dec 3 2019, 06:19 AM


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Posts: 621

No it's not. Are you forgetting they also have a board member with high level contemporary commercial US experience steering the roll out and that means all we have to do is trust Wolgen when he says we should?
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Frogster
Posted on: Dec 2 2019, 06:36 PM


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Posts: 621

I think it's well known on this board that orphan exclusivity protects against generic competition in the given condition only.

I think it's also well known that Scenesse has an advantage over any new entity entrant that would have to show a clear advantage over it.

The efficacy of 7117 in comparison to Scenesse is unknown. The safety profile in comparison to Scenesse is unknown. The pill form has an arguable advantage in ease of use, but that has to be argued against controlled, sustained release of the implant.

7117 is certainly worth watching closely, but there is also a need to remain level headed in discussing it.
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Frogster
Posted on: Dec 2 2019, 09:22 AM


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Posts: 621

An attempt at calming verbiage which I guess is nice in intent, but still no details at all on time lines, dates, specific therapeutic targets etc. etc.. How long have we been waiting for the fabled 3rd indication to be clarified? How long have they been preparing for trials? Sounds a familiar story to the VP trial which should've been done and dusted by now. Also, what's with the final chapter rubbish? Do they sit on their hands beyond this point?

Wolgen's AGM effort has been praised for talking the DNA concept up, but widely criticised for it's lack of investable detail around it. To me, this letter is little different, and I'd like to see them do better.

The CEO has his share package, the management have theirs, there's a new Chairman and 2 new Board members. Time that CUV upped it's rate of delivery.
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Frogster
Posted on: Nov 30 2019, 01:25 AM


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Posts: 621

If the gold standard P3 trial was for MT to do a comparative study, given CUV has complete and total control of distribution, how would MT get hold of the Scenesse implants it would need? Surely CUV can't be forced to supply for purposes that might harm itself? Therefore, could a gold standard comparative trial even be possible? Maybe this defensive benefit is part of the reason CUV has taken the control path it has? It'd help keep generics at bay later down the track too.
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Frogster
Posted on: Nov 26 2019, 05:42 PM


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Posts: 621

Sorry to leave you hanging Macgyver. I've been on holiday since the AGM and had more interesting things to do than type up thoughts on CUV. However, today I've returned to reality and ground out the following for you. Not in any particular order, and repetitious of some comments made here since the AGM by others. In summary, to me, Clinuvel remains the Curate's egg of the investment world. Some things about the company bug me and, I expect, will continue to do so, but the trajectory remains a compelling one.

Management Remuneration

PW has got his rights package across the line. In my view, the quantum he demanded was excessive, but it’s done now and I hope the milestones are achieved swiftly. I actually consider the trojan horse methodology of pushing a generous management equity scheme through as more significant than the package for PW. We all know that he has built a very tight team around himself. They have shown him great loyalty, and he to them the same. He’s now ensured that with modest further positive corporate developments his team will become wealthy, and with major success, they will become stonkingly rich. If you’re “in” with PW, there is no doubt that he’ll fight for you.

So far the estimate of how much might fall to management below PW sits between 5.8 (MattCUV) and 8.8% (me). The trojan horse approach of getting Blijdorp to make the detail of the scheme “public” by announcing it in the meeting to me is pretty sharp since 1) no indication of scale had been given to those who awarded proxy votes to the chair (directed or otherwise) 2) the detail was given only seconds before voting occurred 3) the details themselves were hard to understand (several other attendees I discussed this with found it equally as unclear as I did) 4) Given the detail was not delivered by the Chair or the CEO, it’s content hasn’t been disclosed to the ASX.

I’ve asked CUV IR for the detail of what Blijdorp said, but I’ve received no reply to that request. I promise I asked for it in a very civilised manner so I don’t understand why I’ve not had one.

I think it’s disappointing that they’ve gone about it this way, but it’s done. He, PW, has looked after himself, and now he’s looked after the team. Why is this so important? Well, I think it makes the possibility of takeover a far more palatable one for PW and the Board to look at favourably. Now, no one on the inside will miss out on the riches if it happens. I’m not saying I think it’s a short term certainty, only that PW now knows his team will all be just fine in the event one occurs.


DNA repair

I’m very glad to hear PW talk this up as the next stage. We’ve obviously all thought about the potential in the past, but to have the company admit this is the goal is great. CUV has set out it’s stall. It’s been said on here since the AGM, but this could be seen very easily as an attempt to entice a buyer our way. Again, maybe not today, but should there be success in those trials I could imagine something happening pretty quickly.


Timelines/Communications

I’m not shocked there’s no detail around the timelines of anything. A little while ago in a post on here I explained why I thought they’d not change their approach and I’ve posted it below rather than type it out again.

They can’t stand the scrutiny it brings when they miss timelines. PW will do much to protect himself and his team. They, the Board included, will not accept any comment that their execution hasn’t been perfect and so it seems like an obvious move from them to drop anything that enables objective and quantified commentary from the like of us when things don’t hit the plan. I think it’s a sign of corporate immaturity, and it’s disappointing, but not very surprising.

Stan M, in his outgoing commentary, makes the point that the quantity of communications betters that of their peers. However, he hasn’t addressed the quality of communications which, in my opinion, is often ambiguous, lacking in detail or inconsistent. However, they see no issue here. Until they do, nothing will change.


***
Personally, I'm not expecting their communications approach to change very much. I think they'll remain happy to communicate strategies in broad strokes - and it's an exciting strategy - but will continue to be light on making the detail public and very light on the opportunities to be questioned on those details as and when things vary from the broad stroke guidelines. Maybe the frequency of presenting those the strategies will increase (i.e. more investor conferences) but I'd be surprised if the content style changed much. They are great at stonewalling answers to questions, written and verbal, so simply doing more presentations doesn't equate to sharing more detail.


The company has achieved a tremendous milestone with FDA approval. They really have and I congratulate them for this, especially for their determination to get there, but the fact that extreme caution in communication was demonstrated by the way they ran the conference call. The approach of picking which questions they would respond to (the responses we're always answers in my opinion) smacked of this. They didn't need to do this. There were loads more questions that they just ignored.


I think it's simply the case that the cautious approach is their M.O. I can't see why PW would change this. He has never "pumped up the tyres" of any indication, and I don't think he ever will. I'm sure we'll get updated with milestones as they get ticked off - whether on time or delayed - but PW will never hype things. Having come to this realisation, I think I'd worry if he ever did. He's going to leave hyping things up to the likes of us.


Having crossed the threshold of FDA approval, I consider we're moving into a phase of exciting developments which have huge and lasting growth potential. I intend to hold my shares for a while yet, but I have little doubt that aspects of the "Clinuvel way" will continue to annoy the hell out of me for a long time to come, but I hope this will be tempered by what the growth does to the stock price. If they'd hired many proven, experienced operators to get us through the FDA quicker and run the paused programs in parallel I wonder what that'd have cost in total? Would that have left us in debt? Would they have diluted us significantly?


Without a change in management, I don't think there'll be change in management approach. That is, paint broad strategic strokes, keep the details close to your chest, manage cost conservatively and ensure a tension with shareholders by keeping relationships at arms length balanced by avoiding dilution and delivering earnings growth. Over the years that approach has worked for us, and may it continue to do so.

***


Board changes

Dr Sue Smith and Professor Jeffrey Rosenfeld both are highly credentialled new Board members. Dr Smith spoke briefly at the AGM, and I thought she came across well. I have high hopes they will revitalise the Board and bring a new and valuable independence which has been a little lacking of late. I think they have a large hole in Board level experience when it comes to contemporary commercial experience in a US setting, so I hope they are planning to supplement the Board with someone who knows their way around the current field of play. We can’t afford L plates in this role, and I hope the new Board members will quickly realise this.
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Frogster
Posted on: Nov 21 2019, 06:07 AM


Group: Member
Posts: 621

Lh2000, you are quite wrong. It might be hard to hear something when you are in the room. It's a lot harder when you aren't.

There will be dilution via rights issuance to management. You only have to get holders to vote on rights issuance to directors. It's the old sleight of hand thing again.
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Frogster
Posted on: Nov 20 2019, 02:19 PM


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Posts: 621

So what seems to be missing from the discussion so far is that Bjidorp also addressed the meeting. This was immediately ahead of the voting section. He was reading from a prepared paper, but I can't see that this has been published to the ASX. I wish it were, because it was really hard to understand what he was saying.

He was encouraging shareholders to support Resolution 4. He also revealed the quantum of shares that will me awarded to management if R4 was passed and all the hurdles met. In my notes I think he mentioned 8.8% dilution from them. I'm not 100% sure on the figure since he stumbled on the delivery of it. I'm also not sure if that figure included or excluded the 3% dilution Wolgen personally could be awarded. This whole section was hard to understand.

It doesn't seem to me to be very appropriate to drop such significant dilution into an informal comment seconds before a vote, especially when the detail was not available to those who'd nominated a proxy vote.
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Frogster
Posted on: Nov 18 2019, 09:28 AM


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Posts: 621

Is anyone on here a member of the Australian Shareholders Association? If yes, could you share their AGM voting suggestions for Wednesday? It'd be interesting to hear which way they're leaning.
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Frogster
Posted on: Nov 14 2019, 03:46 PM


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Posts: 621

Now. If you are voting by nominating the chair as proxy, you have till 10am on Monday to lodge your request. You can do this online with Computershare. Your papers should have arrived ages ago. Have you nominated to get online notifications? If yes, check your spam folder. If you are voting in person at the AGM, well, you have to be there.
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Frogster
Posted on: Nov 9 2019, 03:01 PM


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Posts: 621

Johnny, thanks for highlighting some details of record from those FDA papers. It may not make for edifying reading, and I'm sure we'd all rather believe the whole application was flawless and perfect, but I for one would rather the facts are out there minus any spin. What we all choose to do with that information, how we interpret it's importance historically and how relevant it is going forward, is obviously down to the individual and their own approach to investing, risk management and trust. May we all come to conclusions that we are all comfortable with in the long term.

LJS, The Corporation Act requires a listed company to have an AGM for it's members. Members are those who own shares. A company is under no obligation to allow members of the public into an AGM, though many may choose to do do as a policy. ADR holders do not own shares, therefore they are not members and have no automatic right of entry. They could be allowed entry as guests, but that is at the sole discretion of management. Validly appointed proxies are allowed to attend the AGM on behalf of members, but those are the only people, other than members, that CUV is required to let in the room.
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Frogster
Posted on: Nov 6 2019, 04:34 PM


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Posts: 621

I'm not sure if it's the last date to update the detail of Resolution 4 before the AGM, but what I do know is that AGM resolutions can be withdrawn right up to the point they are voted on. Please see the attached document which confirms this on page 5. The Board is not bound to hold a vote on Resolution 4 as it currently stands at the AGM.

For anyone who thinks Resolution 4 is flawed, as I do, you have the option to suggest to the Board that it is withdrawn, reconsidered and voted on at a later date under an EGM. I have done this via the IR submission form on the Clinuvel website. This appears to be the favoured method the company has to accept investor contact. We must assume management will fulfill their obligation to pass such comments to the Board.

Withdrawing, redrafting and resubmitting Resolution 4 would be a better outcome than seeing it voted down given the numerous questions, omissions and apparent largesse in some terms that at least some of us are concerned about.

Attached File(s)
Attached File  guidelines_for_notices_of_meeting.pdf ( 76.12K ) Number of downloads: 44

 
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Frogster
Posted on: Oct 30 2019, 05:49 PM


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Posts: 621

I agree with several of your points, but I don't see there is any overall benefit in their misremembering/misrepresentation of observable history.
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Frogster
Posted on: Oct 30 2019, 04:26 PM


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Posts: 621

From today's TGA press release:


“The submission of the scientific data on SCENESSE® to the TGA was always planned to occur after obtaining European and US approval,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.


This is a great example of the kind of behaviour from CUV which really annoys me. They are trying to rewrite history in a way that favours themselves. That statement is inaccurate.

The 2017 AGM presentation, p40, showed an anticipated TGA filing late Q3/early Q4 2018. p42 shows, at that stage, the FDA PDUFA date was expected to be Q1 2019, so clearly at some stage it was anticipated TGA submission would run in parallel with ongoing FDA consideration and NOT wait until US approval was given.

Timings change, and strategies change. I get that and don't have major issues with many of the reasons which cause delays. I'm not holding them to those particular dates, but please don't take us for mugs and claim you always planned it this way. You didn't, and any claim otherwise can only be seen as self-serving. Lodging with the TGA next year will trigger a performance clause in the Rights package they are seeking approval for, as would subsequent approval. If they'd filed on previously disclosed time frames, no such triggers would've been made. So, to me, a little more honesty and accuracy is in order since a big pay packet is linked to these claims.

I think the management has achieved something really great with FDA approval, and there is a bright future ahead for the company. PW in particular has already been handsomely rewarded for his efforts. I have no doubt PW and Management deserve to be rewarded well for any further significant progress, but I guess my view of "well" differs a bit from that of the Board. Also, some of the terms in the Performance Conditions, on reflection, are so loose you could drive a bus through them.

PW extolls the virtues of situational awareness. I'd encourage the company to develop a little more self awareness too. That means being happy, and even proud, to have achieved what they have, but please do not try and claim perfect execution and strategic vision and please recognise when your execution has varied from what you have presented to us.
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Frogster
Posted on: Oct 30 2019, 11:16 AM


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Posts: 621

That would've been more helpful if he'd explained why the recession clauses are so soft. 9% outperformance of an index wouldn't even rate as a Strong Buy at most investment houses, and yet it would see full payout, with the choice of 2 indexes as the baseline!
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Frogster
Posted on: Oct 26 2019, 08:53 AM


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Posts: 621

I think there are hints in the AGM papers that in their minds a Nasdaq listing is still very much on the cards, even if it isn't explicitly stated.

There are several peculiar things about the PC1 "recession" clauses, not least the following:

"Only in the case of a recession in the country of the Company's primary market exchange....." It's obvious, isn't it, where the primary market exchange is? It's Australia. If the listing status quo was certain to be maintained for the foreseeable, why write a clause that provides flexibility to move away from the current status if that was not a possibility being considered?

Also

"The Company's growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index......" So, this statement is a s clear as mud. They've mixed absolute performance metrics with relative ones, and provided themselves with a choice of indexes to outperform, one reference priced in A$ and the other in US$. They may have done this to make it even easier to achieve the clause thanks to currency movements, or they may have done this to automatically switch the reference index should the "primary market exchange" change to one where that has a different reference currency. You can take your pick as to which is most likely.

Of course, they could clear this kind of rubbish up very easily if they chose to engage with valid questions and not assume their lawyers and consultants have covered every issue beyond query.


On the issue of questions for management, a couple of points that may be of use to shareholders who cannot physically attend the meeting. In the 2019 Corporate Governance statement where the company states it complies with principle 6.3 it states:


6.3 Comply

A listed entity should disclose the policies and processes it has in place to facilitate and encourage participation at meetings of security holders.

The Company encourages full participation of shareholders at the AGM to ensure a high level of accountability and discussion of the Company’s strategy and goals. The AGM exists, among other things, to promote shareholder communication by providing shareholders an opportunity to ask questions to Directors at the time of meeting. Directors are expected to make themselves available to meet with shareholders at the AGM. The external audit firm partner in charge of the Company audit is available to answer shareholder questions at the AGM. Shareholders who are unable to attend the AGM or other general meeting may submit questions and comments before the meeting to the Company or the external auditor (in the event of an AGM). Also, shareholders are permitted by the Company to vote online and by other methods prior to the AGM if they are unable to attend.

I can't find any instruction at all in the AGM voting papers as to how shareholders who can't attend should actually submit any questions they may have, but I suppose you could use the submission form on the website. I'm sure those who attend the meeting will report back privately if your questions were asked, and also what the answer was. It's interesting that the principle CUV says it's complying with encourages participation of security holders - not shareholders. I wonder if, from a technical perspective, if CLVLY and UR9 are securities or shares?


Finally, for those questions of how to cast your vote, if IR isn't helping you out much, I note that the final point on the AGM paper is:

h) If you have any queries on how to cast your votes call Darren Keamy on (03) 9660 4900 during business hours.

That might be worth a shot.
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Frogster
Posted on: Oct 25 2019, 05:39 PM


Group: Member
Posts: 621

http://www5.nohold.net/Computershare/ukp.a...mp;cpage=vagent
Maybe try the online form and process suggested on this page. It's Computershare UK based advice, but since I don't know how and where you hold your shares it might just work (and, it might not!).
Good luck getting some representation on your investment. I sometimes think they momentarily forget they're a publicly listed company.
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Frogster
Posted on: Oct 24 2019, 11:12 AM


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Posts: 621

I'm pretty sure the ADR agreement says the shares held by BNYM on your behalf will not be voted unless you have directed your vote. Of course for that to happen, CUV has to ask BNYM to enquire what your voting intention is.
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Frogster
Posted on: Oct 19 2019, 02:58 PM


Group: Member
Posts: 621

I like the A$7.5bn mkt cap incentivisation bit. It's a demanding hurdle, but gets well rewarded. Multiply the shares price approximately 5 fold from current levels? Sounds good to me.

What I'm not so keen on is what the targets become if we have a recession, and lets face it that's quite possible in the next few years. Under those circumstances, he gets the same reward (number of shares) by outperforming a biotech index by a bit (only 9%!!!), over a calendar quarter. Whats very unclear is what happens if there is a recession which we come out of quickly. Does the switch to the "outperformance" metric stick, or do the targets switch back to mkt cap based ones? Let's say a recession hits in the next 6 months, but immediately thereafter we exit it. If the metrics do not switch back, then essentially there's 3 years left to outperform a bio index for just one quarter. These metrics seem very weak by comparison to the mkt cap. ones.

The other thing that's a bit unclear is where they say they intend to introduce a similar rights scheme for managers. Presumably that's CFO, CSO, LH and maybe others. It's possible to read what they've said as implying the same quantum of shares will be issued as for PW. So, does this bit mean they intend to issue ANOTHER 1.5m shares to non board level management as well?

"Following the Meeting and subject to Shareholder approval of Resolution 4, the Board intends to grant senior management Performance Rights under the Performance Rights Plan as a means to provide further incentivisation for their commitment to the Company’s commercial development under Dr Philippe Wolgen’s management direction. These Performance Rights will have similar or equal Performance Conditions to those attached to the Performance Rights to be granted to Dr Philippe Wolgen upon approval of this Resolutions, to align the interests of senior management with those of shareholders"

I'd like to understand how many shares might apply to this bit, cause 1.5m seems quite a few to me!
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Frogster
Posted on: Oct 18 2019, 11:59 AM


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Posts: 621

I agree. That bit is quite a soft touch.
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Frogster
Posted on: Oct 18 2019, 10:47 AM


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Posts: 621

AGM papers show a proposal to issue up to 1,513,750 performance rights to PW with a 4 year expiry date.

Hurdles to get maximum issuance include:

-Market Cap above A$7.5bn for at least 15 trading days
-A$150m in cash and equivalents held on the BS
-Launch of OTC VALLAURIX product
-Submission AND approval of another pharmaceutical product

There are plenty layers and grades of how much he gets for what, but the terms appear at first glance to be much more mature than those applied to the last rights plan. The biggest incentive, at approximately twice the size of the next biggest, is the Market Capitalisation/outperformance metric. That should please some of us on here.

At approx A$46.5m worth at current share price, how close does that get him to that football team?
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Frogster
Posted on: Oct 17 2019, 11:17 AM


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Posts: 621

I'd say it will be within the coming weeks.
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Frogster
Posted on: Oct 14 2019, 07:23 AM


Group: Member
Posts: 621

Personally, I'm not expecting their communications approach to change very much. I think they'll remain happy to communicate strategies in broad strokes - and it's an exciting strategy - but will continue to be light on making the detail public and very light on the opportunities to be questioned on those details as and when things vary from the broad stroke guidelines. Maybe the frequency of presenting those the strategies will increase (i.e. more investor conferences) but I'd be surprised if the content style changed much. They are great at stonewalling answers to questions, written and verbal, so simply doing more presentations doesn't equate to sharing more detail.

The company has achieved a tremendous milestone with FDA approval. They really have and I congratulate them for this, especially for their determination to get there, but the fact that extreme caution in communication was demonstrated by the way they ran the conference call. The approach of picking which questions they would respond to (the responses we're always answers in my opinion) smacked of this. They didn't need to do this. There were loads more questions that they just ignored.

I think it's simply the case that the cautious approach is their M.O. I can't see why PW would change this. He has never "pumped up the tyres" of any indication, and I don't think he ever will. I'm sure we'll get updated with milestones as they get ticked off - whether on time or delayed - but PW will never hype things. Having come to this realisation, I think I'd worry if he ever did. He's going to leave hyping things up to the likes of us.

Having crossed the threshold of FDA approval, I consider we're moving into a phase of exciting developments which have huge and lasting growth potential. I intend to hold my shares for a while yet, but I have little doubt that aspects of the "Clinuvel way" will continue to annoy the hell out of me for a long time to come, but I hope this will be tempered by what the growth does to the stock price. If they'd hired many proven, experienced operators to get us through the FDA quicker and run the paused programs in parallel I wonder what that'd have cost in total? Would that have left us in debt? Would they have diluted us significantly?

Without a change in management, I don't think there'll be change in management approach. That is, paint broad strategic strokes, keep the details close to your chest, manage cost conservatively and ensure a tension with shareholders by keeping relationships at arms length balanced by avoiding dilution and delivering earnings growth. Over the years that approach has worked for us, and may it continue to do so.
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Frogster
Posted on: Oct 12 2019, 06:42 AM


Group: Member
Posts: 621

Now that the FDA has accepted Scenesse essentially enables 6 hour pain free sun exposure and that it has established a good real world safety profile, I wonder if CUV will (or even can) go back to the EMA to formally update that approval with the more appropriate efficacy analysis and to remove the "exceptional circumstances" tag. It might be expected that formally accepting the efficacy data which the FDA has would significantly ease and extend further European rollout. On the other hand, will CUV simply leave peer group pressure to do its thing and continue operating with the limitations of the EMA approval status quo?
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Frogster
Posted on: Oct 11 2019, 02:07 PM


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Posts: 621

Any more takers for the Melbourne get together next Thursday? Let me know.
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Frogster
Posted on: Oct 10 2019, 06:14 PM


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Posts: 621

Good find.


It looks like FB Rice is just providing the location, with the event having been organised by Monsoon Communications. They were mentioned as the media agency covering Australia in the media (as opposed to the Asx) release yesterday.


CUV is beginning to market itself

On that issue a friend of mine recently bought some CUV through his broker, Shaws. His broker knew not too much about the company, but he expected a whole pile of extra coverage following our second major regional approval. Providing at least some access to management for brokers and analysts will be key to that. Not many investment houses will take the Sphene approach of in depth coverage despite no access to executives. Twilight Briefings and the like should be very helpful to us in that regard.
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Frogster
Posted on: Oct 10 2019, 11:09 AM


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Posts: 621

I think the chances of this have increased dramatically since yesterday. Given how tightly the shares are held, and how diverse and dilute the shareholder base, I can only imagine it getting up at a "good" price for current holders. I wouldn't actually be surprised if the "odd" trading ahead of approval was some mechanism of quietly building a stake. It will be interesting to observe from here on.
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Frogster
Posted on: Oct 10 2019, 07:08 AM


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Posts: 621

With the stream of posts on here since yesterday, I thought I'd repost the suggestion of a Melbourne get together next week lest it gets lost in the mix. I'll likely do the same again tomorrow before deciding the format and booking as appropriate.

So far we're looking at a nice dinner with board members whose characters come across as erudite, provocative, challenging, intellectual, informed, humorous and sophisticated. I only hope the face to face reality lives up to such expectations.


**********
Wow, what a night. What a day.
It's been a long haul to get here, with fun and frustrations along the way.

I'd be keen to have a drink with any of you who would like to mark this milestone.

So, next Thursday (I think we're all too frazzled to do tonight!), 17/10 around 6.30pm somewhere in the Melbourne CBD for drinks/bar snacks or drinks/dinner, depending on numbers.

If you're interested, let me know via private message ASAP and we can work out the details from there.
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Frogster
Posted on: Oct 9 2019, 04:13 PM


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Posts: 621

Nor mine.

Don't like that "selected questions only" approach.
Despite that, today was still a good day.
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Frogster
Posted on: Oct 9 2019, 12:38 PM


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Posts: 621

Wow, what a night. What a day.

It's been a long haul to get here, with fun and frustrations along the way.

I'd be keen to have a drink with any of you who would like to mark this milestone.

So, next Thursday (I think we're all too frazzled to do tonight!), 17/10 around 6.30pm somewhere in the Melbourne CBD for drinks/bar snacks or drinks/dinner, depending on numbers.

If you're interested, let me know via private message ASAP and we can work out the details from there.
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Frogster
Posted on: Oct 9 2019, 08:59 AM


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Posts: 621

Where's punkassderm? He should be joining in with the celebrations!

Whilst I'm very happy for us all financially, I'm just loving reading the joyous comments from patients on the social sites. I don't mind admitting some have moistened my eyes. We're (very) happy, but their lives are about to be transformed.
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Frogster
Posted on: Oct 9 2019, 03:27 AM


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Posts: 621

What super news for patients, the company and us.

It's been a long road to get here, but what an achievement.

I think I may try to get some sleep now. Would it be wrong to open a bottle of fizz with my breakfast All Bran in a few hours time?
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Frogster
Posted on: Oct 1 2019, 09:07 PM


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Here's a little detail on the recent launch in Denmark:


https://www.tv2fyn.dk/artikel/nu-kan-han-ta...ynsk-behandling


The doc calls Scenesse “groundbreaking” and “life altering” for the patients.

73 EPP sufferers in Denmark. 3-40 are eligible for treatment (probably the proportion who are adults).

100,000 DKr per implant = 15,500 USD. 4 implants per year.

Joachim says it has changed his life dramatically.
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Frogster
Posted on: Oct 1 2019, 10:09 AM


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Remember that the FDA can still be late in its response without another formal delay being invoked.
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Frogster
Posted on: Sep 27 2019, 06:40 PM


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Billy, what will you complain about if we get approval next week?


We all know it's been a long road, we all know some missteps may have occurred, we all know PW gets very well paid. I'm sure obsessing about volatility at this stage won't help any.


Maybe chill a little and come back in a few weeks and check if there's something to really complain about, or maybe even to celebrate.
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Frogster
Posted on: Sep 23 2019, 10:43 AM


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She will resign and stand for re-election at the upcoming AGM. You'll be able to vote on her appointment then.

Oh. Hold on.....
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Frogster
Posted on: Sep 13 2019, 02:57 PM


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Has anyone seen any detail from the safety and effectiveness data that was presented this week at the ICPP? I can't find it.

Announcing via press release it's being presented is all well and good, but I'd also quite like to know what the data actually shows.
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Frogster
Posted on: Sep 11 2019, 05:32 PM


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Hold on......you didn't mention the takeover????!!?
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Frogster
Posted on: Sep 11 2019, 05:24 PM


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So is the William Wallace character (Mel Gibson) representative of PW? Maybe he's a bit short to properly represent WW, but then so was Gibson.
Who, then, is Stan? What about LH? Would DK be on the front line, or at the back sharpening swords?

And who are the attackers? Angry, upset, nervous shareholders? The FDA? Maybe NICE (since they're supposed to be English). Maybe they're the shorters, or even the long awaited corporate interest that X ray reminds us of from time to time.

Whatever the case, WW and Scotland shone bright for a while, but he met a rather nasty end. As for Scotland, it made it's own unique way in the world for a while, only to be subsumed by a richer, larger competitor. At least, again, for a while. Perhaps that'll change again after 31 October.
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Frogster
Posted on: Sep 10 2019, 07:52 AM


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The slide posted by Sharelooker, according to the BPA twitter feed, came from a presentation delivered by Dr Rocco Falchetto.

As we know, he co-founded the International Porphyria Patient Network (IPPN) with Dr Jasmin Barman-Aksozen and that slide looks to me as if its come from a presentation on Sunday 8, probably "The Power of the Patients voice" or "The Empowerment of the Patient". My read is that he is about to explain why/how/when the IPPN was formed. He's not saying there "is" still confusion, but rather, there "has been" confusion.

Those themes are very close to the content of a great article posted on here by Seeva back in early August, written by Dr J B-A in which she discusses why/how/when they formed the IPPN:

https://journals.sagepub.com/doi/10.1177/23...eShareContainer

So, my guess is that the rest of his presentation would've hit upon the main points made in this article i.e. clumsily applied statistics can't always tell the full story, and patient experience is a critical part of any sensible assessment. Another way to put it might be that the presentation looks like it's probably a slide interpretation of the paper.

Read the paper if you haven't already - it's quite interesting.
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Frogster
Posted on: Sep 3 2019, 03:52 PM


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Posts: 621

A Director buying a few ADRs? That can't be a bad sign at this stage of the process.


Attached File(s)
Attached File  3A523337_CUV.pdf ( 182.85K ) Number of downloads: 263

 
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Frogster
Posted on: Aug 30 2019, 08:45 AM


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Posts: 621

I have no problem with management interests being aligned with shareholders. Indeed, like you, I very much want them to be. However, for me, the detail of how it's brought about and its extent is what matters. We don't yet know the detail of what is being offered to CEO/CFO this time round, so I think it's premature to take a final view on things, but what I'd say from previous experience with their schemes is this:

- any rights schedule should have timelines associated with it. Last time there were no expiry dates. We know how dreadful CUV is at hitting it's own delivery schedule. Sometimes this may be out of their hands, other times not. Whichever is the case, they simply need to accelerate their delivery and stop with their excuses and avoidance of responsibility.

- any performance hurdles need to be real challenges. Last time the 1st Performance Condition was that the rights plan be approved - a somewhat circular achievement! The 4th Condition was the submission of the NDA - not it's approval, but the submission. I don't mind paying up for good outcomes, but I'm less inclined to be so generous for following process.

To me, it should be a matrix of reward. Perform your job, and not especially quickly, you don't get any great bonus. Deliver a stellar outcome, and quickly, get rewarded handsomely.

What's different this time round is Blijdorp is Chair of the Remuneration Committee. He wasn't on the Board in 2014, and had no role in the last big rights package. His view that management should have up to 20% equity is, for me, too high for a company not founded by current management, but I'd be OK at up to 10% or so (with appropriate hurdles to get there). What I do very much like is his view that the Board should NOT be involved in Rights schemes. To me this is how it should be. The current Board has been way too cosy with management, and they shelter themselves from scrutiny by disenfranchising major groups of shareholders. 2 board members have been there for over 10 years - no longer independent by their own measures, and the most recent addition smacks of historical fondness rather than proven board ability. Moving to a more "arms length" approach is to be welcomed, and I'm hopeful that terms associated with the next Rights scheme will be similarly more appropriate.

So, I'm willing to wait to see the details before taking a view, but no doubt I'll remain very skeptical that the delay in negotiating new terms is down to the executives being busy as opposed to driving the AGM vote into the nice warm window we'll all experience if the FDA says yes. I can't imagine a big, generous rights package getting up if the FDA says no!
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Frogster
Posted on: Aug 28 2019, 06:21 PM


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Posts: 621

I don't think you should assume a NASDAQ listing is off the cards. Indeed, the CFO didn't trigger his cash BGI for either a listing or expansion through acquisition before 30/06/19, so those incentives have lapsed. However, both he and PW are (still) in contract negotiations.

As per Blijdorp on p13, the new agreements are with the lawyers for review right now. He states that a goal of them is to reduce short term incentives and business generating incentives settled in cash, and replace these with shares via conditional rights. I'm pretty confident these new employment terms will include share based incentives for a listing and acquisition, and, for PW an addition of other metrics.

Given Blijdorp has reiterated his view that he likes management to have up to 20% of a company, we can assume the equity on offer to management will be quite significant in magnitude. Presumably there will be a vote on the proposed scheme at the 2019 AGM which will be held shortly after a hopeful FDA approval.

Sounds to me like a pattern similar to the EMA approval which was very shortly followed by a vote on the generous 2014 Performance Rights Plan. A cynic might assume some linkage between the delay in the new employment terms and the delay in the PDUFA date, and not simply that the executives have been quite busy.
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Frogster
Posted on: Aug 20 2019, 09:25 AM


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Newsletter out.


No further delay anticipated, though not guaranteed.
Reminder, yet again, to expect similar pharmacovigilance in US and EU.
Intention to distribute by themselves in the US.
Might increase IR function.

Thin on detail, as you'd expect. Only a few foreign language references. Hand holding exercise.
Attached File(s)
Attached File  447mmgqw64f8kv.pdf ( 424.23K ) Number of downloads: 126
Attached File  447mmgqw64f8kv.pdf ( 424.23K ) Number of downloads: 40

 
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Frogster
Posted on: Aug 18 2019, 09:43 PM


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I don't disagree that Fda approval would be of seismic magnitude, but I do think that if there are ambitions to be a broad based company, simultaneous progress on parallel fronts is not an unreasonable thing to expect. I just hope they been doing something in this vein and not (yet) telling us about it.
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Frogster
Posted on: Aug 18 2019, 09:05 PM


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Agreed. There is So MUCH stuff that has gone dark since the Fda application delays/extensions that we might hope for a whole raft of newsflow after any approval.

Regarding VP, that was due to start European spring, with 6 or 8 month follow up (can't remember the precise detail) so that should be ongoing.

There should have been another indication announced early this year. What's going on with paediatric scenesse? Where are the oft referred acquisitions....... Etc etc.

I get that some stuff strategically relies upon fda approval. I'm not sure I get why everything seems to be waiting for it.
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Frogster
Posted on: Aug 16 2019, 04:16 PM


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We're not (yet) listed on the agenda for the August meeting. No meeting due in September AFAIK.
Ho hum. Twiddle twiddle. More hurry up and wait.
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Frogster
Posted on: Aug 7 2019, 01:26 AM


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Double post delete.
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Frogster
Posted on: Aug 7 2019, 01:26 AM


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There's no doubt that in the last few days the big market trade has been to take risk off the table. This approach make last a while, or it may reverse tomorrow. Who knows?

What there is also no doubt of is that should the FDA give us the go ahead then that will be the the biggest single derisking event CUV will ever likely see. It'll be far bigger than the European approval since it'll open the door to a bigger, single market place. As seeva referenced the other day, it'll also unlock the door to the much bigger opportunities that lie beyond EPP and, for most of us, that's probably what got us involved in the first place.

We're an odd beast. Low risk versus typical biotech (EU approval, sales, profitable, cash generative, no debt, first in class therapy) but high growth versus typical mature pharma business (huge potential for geographic expansion, line extensions, multiple orphan applications).

Should the approval go ahead, for me that will mark the transition from mature biotech to junior pharma. Whether the market is seeking growth or stability over the next fews, if the Fda approves, I think CUV will remain a great place to be.
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Frogster
Posted on: Aug 1 2019, 04:31 PM


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Thanks so very much for sharing these docs Johnny H. Very valuable primary research which you've been kind enough to let us all benefit from. Big thumbs up.
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Frogster
Posted on: Jul 31 2019, 09:36 AM


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The quarter was slightly below my modeling (13.5m vs 13.01m), but up 25% yoy for the quarter is still pretty damn good in my opinion.

Cash at year end was 0.2m below what I was expecting, but when you see that Product manufacturing and operating costs were over 0.4m more than the last guidance and that this is a leading indicator, then I'm fine with it.

For the next quarter, they're expecting to maintain high PM&OCs - above 2m only for the second time - and that advertising and marketing costs will nearly triple from the just reported period.

Sounds like they're expecting something significant to happen soon.
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Frogster
Posted on: Jul 16 2019, 02:22 PM


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Guesses? GUESSES?!?

I'm at A$13.5m for the quarter, 30% growth YoY, and cash at quarter end of A$54.475m.
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Frogster
Posted on: Jul 4 2019, 03:58 PM


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Agenda for NICE HSTEC meeting on 25/7 is available. We're not on in.

https://www.nice.org.uk/event/hstec-july-2019

The next meeting is 29/8.
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Frogster
Posted on: Jun 21 2019, 04:13 PM


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We're now an ASX200 stock.
Respect to PW, his team and all long-term investors.
Now, let's see the fundamentals delivered, please.
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Frogster
Posted on: Jun 19 2019, 03:41 PM


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Get Giles Delaney to do it.
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Frogster
Posted on: Jun 18 2019, 02:10 PM


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You have a job???
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Frogster
Posted on: Jun 18 2019, 01:51 PM


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Posts: 621

Just for kicks I thought I'd have a look at the trading volume of recent additions to the ASX200 between the date their addition is announced, and the last trading day before inclusion.

I looked at the last 5 additions, Cooper Energy, NRW Holdings, Nearmap, Hub24 and Pinnacle Investments. Most of them had 6 trading days from the announcement till the actual inclusion, but NRW had 8. There is a VERY strong pattern that the last day before inclusion is by far the strongest volume day.

If you calculate the daily percentage of the total traded between announcement and inclusion, you get:

Cooper: 4%, 8%, 8%, 8%, 10%, 62% i.e. 62% traded on the last day before inclusion, which is 8.3x the average of the other days
NRW: 8%, 14%, 7%, 8%,8%, 5%, 4%, 46%. Last day 6.1x average of other days
Nearmap: 10%, 20%, 16%, 10%, 8%, 36%. Last day 2.8x average of other days
Hub24: 6%, 10%, 11%, 9%, 10%, 54%. Last day 5.9x average of other days
Pinnacle: 6%, 7%, 8%, 11%, 10%, 59%. Last day 7.2x average of other days

Therefore the AVERAGE final day trading volume multiple on these 5 recent examples is 6.0x.

In the 2 full days of trading since the announcement that we are in, there was an average volume of 252,509 CUV shares traded (ANZ data). If the average final day multiple applies to us, then on Friday we could see a volume of 252,509*6 shares traded. That's 1,515,054 shares.

Wowzers. The current TOTAL offered shares are 32,100.
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Frogster
Posted on: Jun 16 2019, 11:51 AM


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Posts: 621

It doesn't seem unreasonable to me to forecast well above A$0.50 EPS in short order if we get a positive FDA and NICE response.
We had a fully diluted EPS of A$0.267 in 17-18 at the very early stages of European roll out. It depends how far down the track you want to look, but if you judge that at least some of the development goals will be reached, there is still a phenomenal potential growth story here in my opinion.
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Frogster
Posted on: Jun 16 2019, 09:36 AM


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Did you look at the forward p/e too? How might they compare?
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Frogster
Posted on: Jun 9 2019, 05:22 PM


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He doesn't seem to know very much about the detail of what Clinuvel does/intends to do.
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Frogster
Posted on: Jun 4 2019, 03:07 PM


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If that situation occurs, my thoughts would be to look at the available evidence and try to match that against published procedures to understand what had happened. Sure, I'd be pissed off, but I'd try and get to the why, not just wail about the what.

Don't confuse my position with me being comfortable, or even happy, that the process is taking so long. Far from it. I think aspects of Clinuvel's approach has been naive and inefficient, but I'm not seeing anything that suggests the FDA is twisting it's own procedures in order to defeat CUV. Whilst CUV itself isn't always forthcoming with detail, through lots of digging done through this board, plausible explanations have usually been found for delays.

PW has often stated that the dossier is a challenging one due to the innovative offering, the product history and ineffective scientific tools to prove efficacy. I'm less inclined to believe that the bogeyman is behind the various delays than I am to believe that what they're trying to do is really hard and they've made some errors along the way.
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Frogster
Posted on: Jun 4 2019, 01:36 PM


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Clinuvel stated yesterday, in black and white, that the Fda needs more time to study data provided by Clinuvel in the review period. That means data provided after the NDA was lodged. Ergo, the NDA was lacking in some way.

As proven by the document I linked to, extending the Pdufa date is perfectly consistent with a Major Amendment being accepted in an attempt to offset a Significant Deficiency (fda terms, not mine).

Has Clinuvel been incompetent? Perhaps, but then again the list of companies included in share lookers list of other companies with Pdufa extensions includes some very experienced broad based companies. Are they incompetent too? Perhaps, or maybe the fda is a high hurdle to pass.

Regarding patiently waiting, what else can cuv do? They've submitted more data post lodgement. The fda needs extra time to review it since it wasn't in the initial package, and they've applied the standard 3 month extension as per other companies. Cuv has laterly submitted what they think is required I. E. fixed the problem, and now, again, they wait. It's not finger pointing, they're describing the process. Regarding "finite resources", that's a truism. More hands, lighter work. It doesn't mean cuv thinks the fda is twiddling it's thumbs. Many times they've referred to the many fda demands. Cuv knows how finite resources can constrain achievements, just look at how slow our progress has been. I can see how it's possible to interpret the comments as fda shaming, but I don't think that's the right interpretation. As you say, why would they? In my view they are not doing that, they are simply, but clumsily, stating process facts.
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Frogster
Posted on: Jun 4 2019, 10:46 AM


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As with everyone else here, to see this extension is very frustrating. I've tried to step through the process to understand what as happened, and this is what I've come up with. Lots of speculation on my part, but nothing new in speculating on CUV! It's probably not stating much entirely new, but maybe I'm laying it out in a different manner to previous posters (thanks to you all):

Firstly, here's a link to the FDA policy on communication of planned review timelines to applicants:

https://www.fda.gov/media/72710/download

Next, here's what Clinuvel has told us about its communications milestones:

-On 10/1/19 (NDA press release) they told us that labeling and post marketing requirements would be issued by 8/4/19
-On 2/5/19 (Newsletter) they told us with regard to the 8/4/19 deadline "no further news can be reported" and that "the FDA is simply focused on other issues in the review" and "in the coming weeks we may receive the awaited labeling questions". Note that Clinuvel did NOT say the date has passed with no communication, rather that nothing can be reported.

In the FDA document linked above, there's a section which mentions what will happen when "Significant Deficiencies preclude the discussion of Labeling or PMRs/PMCs". Basically it says if they find significant deficiencies in the application, they probably won't communicate about labeling in the target timeframe. They will then tell the applicant these deficiencies preclude the labeling discussion. What the applicant does is obviously up to them. If the applicant responds (with data, facts, arguments etc etc) the FDA will decide if the response constitutes a major or minor amendment, whether it will be reviewed during the review cycle and if it will change the PDUFA date.

So, I think the story goes like this:

-the FDA accepted the NDA from CUV.

-they found what amounted to a Significant Deficiency in the dossier, most likely in the CMC area (in the newsletter PW told us this area was taking up the "lions share" of attention, and it ties in with JHs good work).

-CUV submitted amendments to address these issues (from yesterday: "to allow time to evaluate data provided by CUV as part of the scientific exchange within the review process" and I think collating this has been mostly what PW has been referring to when he's spoken of the team working all hours). I think they were unaware at the time of the Newsletter whether these would be considered minor, major or even would be reviewed at all. I think this uncertainty might be why PW started talking about 50/50 chance of CRL at that stage - he didn't know if the amendment would be reviewed. As it turns out, the amendment has classified as a major one which will be reviewed, with the standard 3 month PDUFA extension which is a better time frame then the alternative of CRL with a possible consequent delat of 12m+ (as PW discussed).

So, to my mind the "issue" lay not with the FDA, but rather on CUV's side, quite possibly and more accurately with their manufacturer. Looking at the great work by Sharelooker, it's clear that a PDUFA extension is in no way an impenetrable barrier to approval, and indeed the opportunity to respond to a deficiency is better than not being able to. Most of the companies SL found use some or many phrases like "more time to respond", "major amendment", "standard 3 month extension" etc. etc., and it strikes me that the release from CUV yesterday, whilst really frustrating, in content isn't much out of line with other communications of a similar situation.

So, maddening as all hell to see another delay, but it seems to me we're no less likely to be approved than we were last week. In fact, we could be more likely since we've had the opportunity to address a Significant Deficiency without a CRL being issued.
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Frogster
Posted on: Jun 3 2019, 09:30 AM


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Posts: 621

Can't say this is a complete surprise. We've been here before. A quick google threw this up as a possible explanation of why (given that CUV, rather disappointingly, isn't telling us):


"But what about moving the PDUFA date itself? Yep, the FDA can and sometimes does move a PDUFA date, though it is relatively rare. The FDA has a piece on it in the Manual of Policies and Procedures – MAPP 6010.8. Unfortunately, it is not available in English, it is written in beaucratese. I will do my best to translate.

The FDA can move the PDUFA date when there is a "major amendment" made to an NDA which can be because the FDA has requested certain information (a solicited amendment) or because the sponsor of the compound submits an amendment because there is new data that has to go into the application, such as results from a study (an unsolicited amendment). In the case of Eisai, it was due to the former situation.

Examples that serve as the basis for a "major amendment" is information about (i) protocol deviations and the impact that they might have had on study outcomes; (ii) that provides clarification about a manufacturing site; (iii) data inadvertently left out of the final study report; (iv) there is new validation data and analyses; (v) updated data from a previously reported study.

Just because there is a major amendment doesn't mean that the PDUFA date will have to be extended, it just means that it can. If the major amendment is submitted early in the review cycle then the division overseeing the application may not choose to extend the date. If however, the information is submitted to the FDA within 90 days of the PDUFA date, then the original PDUFA date will be extended. "



http://eyeonfda.com/2010/08/when-does-fda-...d-a-pdufa-date/
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Frogster
Posted on: May 30 2019, 01:04 PM


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Posts: 621

At the beginning of this month Sharelooker found a NICE reference which suggested the results of the UK NICE HST re-appraisal (after the success of the appeal last year) was expected to be published in June.

We didn't manage to beat this expectation and make it onto the May HSTEC agenda, and their June meeting has now been cancelled (see below). The next meeting date is 25/7 therefore it looks like the newsflow order should now be:

-ASX200
-FDA
-NICE

Personally I'd rather see fundamentals lead the technicals, but I'll not complain about that if they all come in with a tick.

https://www.nice.org.uk/get-involved/meetin...ation-committee
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Frogster
Posted on: May 28 2019, 04:13 PM


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Posts: 621

Have we ever had 1m+ shares traded in a day?
That'll help the ASX200 liquidity calcs.
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Frogster
Posted on: May 16 2019, 05:40 PM


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Posts: 621

In the event of a merger, dealing with a very disparate number of shares in issue on either side of the transaction is a trivial matter. You'd just play around with conversion ratios to make sure that respective shareholders got the appropriate share of value in the new entity. If one party had a gazillion shares and the other 5, it wouldn't complicate a merger at all.
To your question can companies cooperate without merging, the answer is yes. Form a JV (ownership shared between the parties) and do the work through that. You probably wouldn't do that in this case though. The operations appear quite complementary, so if anything is to happen, I'd think an all in approach would be the most sensible.
Yay for the price action today. I'm a bit upset I missed watching it real time - but I'll get over that I'm sure.
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Frogster
Posted on: May 8 2019, 09:37 AM


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Posts: 621

Sounds to me like a securities lawyer had a close look at the signed ADR agreement and decided things hadn't quite been reported correctly in the past. By negotiation with ASIC, the situation has now been smoothed out via the relief process.

There's a little on that process and relevant circumstances here: https://asic.gov.au/about-asic/dealing-with...ply-for-relief/

I might imagine that having a securities lawyer look very closely at your existing listing arrangements might be a step in the process of investigating/instigating another listing elsewhere.

Housekeeping. Ducks in a row kinda thing.

Maybe.
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Frogster
Posted on: May 2 2019, 01:00 PM


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https://www.clinuvel.com/social-media/subq/...he-drivers-seat

Not seen this one listed on here yet. I particularly like the way it links the thesis to Clinuvel and the pharmaceutical industry.
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Frogster
Posted on: May 2 2019, 11:30 AM


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I think the language from PW is entirely appropriate at this stage.

From where we stand in the NDA there are essentially 2 possible outcomes: approval, or non-approval (CRL). 2 outcomes - a binary situation - and whilst not strictly accurate these could be considered as equally weighted outcomes with a 50/50 probability.

Think about the alternative. What if PW was publically stating that either outcome had a probability greater than 50%? Wouldn't that be placing a demand for a certain result on the FDA? Wouldn't that be telling them what to do? To me, that would be a complete no no. I do NOT want PW to be stating any kind of public expectation of what the FDA will decide. It would be entirely inappropriate.

We know that any approval essentially weighs the risk vs reward of a product. As per this newsletter you can re-write that as safety vs efficacy. On the basis of much detailed data that we are not privvy to we know that PW has made many statements expressing an opinion that Scenesse is both safe (PASS data) and effective (High continued usage).

His opinions here may be a very strong, but his job right now is only to convince the FDA his opinions correctly reflect the data and patient outcomes.
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Frogster
Posted on: Apr 26 2019, 10:04 PM


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The line where Wolgen suggested a link between Sphene and Homm - despite no proof - appears to have been dropped from the AFR website version of the article.
I wonder if there was a complaint and, if so, from whom.
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Frogster
Posted on: Apr 26 2019, 02:07 PM


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Wow. If PW doesn't like the pressure of an analyst suggesting $40 fair value, I wonder how he feels about the Chairman talking about becoming a company "an order of magnitude" larger than we currently are!
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Frogster
Posted on: Apr 24 2019, 06:37 PM


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I just had to say thanks to give you your 2000th. Nice work.
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Frogster
Posted on: Apr 24 2019, 02:04 PM


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Totally agree that it's wise to be very wary of "transformative" transactions. They are rife with the pitfalls you mention. However, "inorganic growth" could include licensing molecules, products or product lines. Inorganic growth can be small and manageable. It doesn't have to be hard to swallow. I think that's more PW style.
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Frogster
Posted on: Apr 20 2019, 03:20 PM


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If you aggregate the receipts from customers on a quarterly basis from Q1 12/13 until Q4 17/18 and calculate the proportion that each of these has been for total receipts, then Q1 has averaged 26% of RfC, Q2 21%, Q3 14% and Q4 39%. So, statistically Q3 has been on average the lowest quarter, and Q4 by far the strongest.

Each year can vary quite a bit from these averages due to timing factors, and of course there's a strong growth rate underlying all the data which makes for an imperfect analysis. I think we mostly thought Q2 in the current financial year was surprisingly weak. CUV reported this as being in part due to customers paying more quickly than in the corresponding prior period but they haven't explained if the same behaviour will repeat, or if it will likely have a positive or negative effect on the Q3 results.

FWIW I'm modelling that Q3 will be better than Q2 was, but in light of the timing factor question, my conviction is not strong on this.
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Frogster
Posted on: Apr 18 2019, 02:37 PM


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Safety is always a concern - indeed the primary concern - for any and every pharmaceutical product no matter how benign it may appear and no matter how long it's been used. There are many cases of drugs with a far longer history and wider use profile than Scenesse suddenly being found to have major issues.

Happily, the criticality of this is not lost on Dr W, not will it ever be by the FDA, EMA or any other agency.

I have no reason to think that Scenesse is anything other than a very safe drug, but if you truly believe that safety is a non issue and not even worthy of consideration, then I think you're deluding yourself.
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Frogster
Posted on: Mar 22 2019, 12:31 PM


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I think I may have stumbled across your form/forum. Doesn't seem to be live on the main website. And, sadly, it is a form.
https://www.clinuvel.com/about-clinuvel/inv...ns-contact-form

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Frogster
Posted on: Mar 20 2019, 07:50 PM


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Nothings gonna stop us now.
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Frogster
Posted on: Mar 20 2019, 07:07 PM


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I said the other day that I didn't think the source of any shares would be PW selling off his recent issue due to the fact that these shares are commonly locked up for a period which I suggested might be 6 or 12 months. I also suggested the factual detail might be out there if anyone could be bothered to look for it.

Today, I thought I might bother to look for it.

According to the 2014 AGM notes where the recently completed Performance Rights Plan was approved, and describing shares issued under that plan:


"Any Shares issued under the Plan upon vesting and exercise of a Performance Right will rank equally in all respects with other
Shares for the time being on issue except as regards any rights attaching to such Shares by reference to a record date prior to the
date of their issue. The Company will apply for quotation of Shares issued under the Plan. However, the Shares will be subject to
the following transfer restrictions, and may not be traded on ASX while those transfer restrictions apply:

• A participant is not entitled to trade in any Shares issued under the Plan without the prior written consent of the Board until
the earlier to occur of:

a) 7 years after the date of grant of the Performance Rights;
b) the date on which the participant ceases to be employed by the Company or any of its subsidiaries; or
c) such other date as the Board determines.

• The Company may implement any other procedures it considers appropriate to restrict a participant from trading in Shares
issued under the Performance Rights Plan in accordance with these transfer restrictions."

So, it's clear that any recent selling was not from PWs recent issuance. Perhaps it could be from much earlier share award schemes (again, if you're keen to know, you can likely look it up!) but my feeling is that today's move was just technical in nature.

Tree shake, headfake, retrace - any or all of these. Not driven by fundamantals, or anything in the newsletter IMHO.
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Frogster
Posted on: Mar 20 2019, 01:42 PM


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Well, at least the volume today will bolster the chances of ASX200 inclusion next time round.
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Frogster
Posted on: Mar 19 2019, 01:09 PM


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....and of long-termers.
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Frogster
Posted on: Mar 19 2019, 12:39 PM


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If only the 50% CGT discount was cumulative for each and every 12m holding period and not just the first.
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Frogster
Posted on: Mar 18 2019, 09:01 AM


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Couldn't see this "extra" volume over the weekend, and can't see it today either. Can anybody else? Do we know if the "extra" 700k changed hands or not?
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Frogster
Posted on: Mar 15 2019, 04:18 PM


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Posts: 621

Shares issued to management would usually have a lockup period of maybe 6 - 12 months. I haven't checked if this is the case with the cuv award scheme, but the detail is probably out there if you can be bothered to look. Personally, I therefore seriously doubt the seller here is PW with his new shares. I suppose it theoretically could be with he previously issued shares, but personally I doubt it very much. Given he has inside info regarding the Fda application he's probably prohibited from selling right now anyway. I guess we'll see when/if a change in significant holder notice is published.

My guess is fido or lagoda lightening up. The great news is that someone is on the other side of that sale and in size.

We hit an ATH of 29.99 today, on the biggest trading day by value in our history.

Its the end of a warm Friday afternoon here is Aus. I'm celebrating.
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Frogster
Posted on: Mar 15 2019, 03:04 PM


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What a day - and not yet over. Interesting aftermarket shenanigans.
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Frogster
Posted on: Mar 14 2019, 07:22 AM


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I think you'll find those shares are the newly issued board incentive shares which have now been created since the nda has been accepted by the fda. No money has changed hands.
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Frogster
Posted on: Mar 8 2019, 08:10 AM


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Diary note made for 14 June.
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Frogster
Posted on: Mar 6 2019, 04:36 PM


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Posts: 621

Thanks for the namecheck, but I must say this site has been invaluable thanks to the efforts of many and varied posters over a long period of time. Long may that continue. It feels a bit like an extended family get together in here sometimes. Some you really want to talk to and share news with, some you really want to listen to for their wisdom, some you respect their attendance, are happy to say hi to, but that's enough contact till the next event, some are off their meds and some are off their meds and drunk.


Moving on....

We're hoping for ASX200 inclusion to be announced on Friday. Touching on the post from Johnny H the other day, I was wondering how we're travelling in price and volume terms when compared to the ASX300 announcement, so I added the numbers up (I think this includes both ASX and Chi-x data, though I'm not 100% on that).


ASX300 inclusion was announced on 7/9, with the index changes taking effect on 24/9

In the 10 trading days prior to and including the announcement the shares went up 27%, 784,268 changed hands at a daily average volume of 78,427.
In the 10 trading days after the announcement but before inclusion the shares went up 23%, but with nearly double the volume at 1,492,400 (149,240 daily average).
In the 10 trading days including and after index changes took place the shares rose another 16%, and total volume was 1,412,577 (141,258 daily average).

Assuming a positive annoucement on Friday, we've just seen the close of day 8 in the first block of 10. In that period the shares have risen 19% with a total volume of 904,285, giving a daily average of 113,036.

Since the move into the ASX200 is a bigger deal than the move into the ASX300 I'd guess that more traders might try to trade the inclusion. That might explain the near 50% increase in daily volume so far "this time round". Looking forward, given that more index funds track the ASX200 than the ASX300 and that more active funds will be able to invest due to mandate restriction, if we're included announced come Friday, I wonder if we'll see an even bigger (i.e. more than double) volume impact over the coming months.

Whatever happens, I guess we'll be watching with interest.
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Frogster
Posted on: Mar 4 2019, 02:29 PM


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Lol.

I hear what you're saying, but as we know it's not the m.o. of Wolgen to hire those with a proven track record in the field in question (think Agersborg on the board, LH in IR then general manager, think training from with and Clinuvel university). Mr Bull seems to have some solid commercial banking experience, but nothing in IR. He was never going to shake it up from day 1. I hope he can grow into the role and make it his own.
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Frogster
Posted on: Mar 4 2019, 11:58 AM


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Posts: 621

First public namecheck for Mr Bull, the new IR Manager. Will be interesting to see how his profile develops.
Looks like this is an East coast Aussie only roadshow - delivered by Keamy. First one of those that they'd done for many years if my memory serves me well.

Nothing stunningly new (as you'd expect) but it does list "2nd indication Q1 19" as happening. This is comforting to me. I wonder why they only call it 2nd though. We have an approval for EPP. We know they are targeting VP also. Wouldn't that then make the next indication the 3rd? Or does this imply an indication beyond the porphyrias? Also, how does vitiligo fit in, especially since we've already had a few trials there?

US approval would "potentially double our EPP addressable market". Nice, and timely given the few comments recently about the size of the US market place.

EU expansion - "additional expert centres" are listed as the first point in "What's next?" Not clear if this is more centres in NEW countries, or more centres to address the bottlenecks in Germany for example.

Overall, nice to see more communications taking place.
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Frogster
Posted on: Feb 27 2019, 03:11 PM


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What intrigues me here is that the index tracker funds are unlikely to be front running any index changes. After all, they are passive only funds which invest on data, not speculation. However, plenty of active traders will be trying to position themselves ahead of any news. So, by my way of thinking, this volume is not driven by index funds. Yet.
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Frogster
Posted on: Feb 7 2019, 06:18 PM


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Wake me up when it's 123.45. smile.gif
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Frogster
Posted on: Feb 7 2019, 01:41 PM


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No, I don't think that's right. From memory 2 PSURs have been made annually to this point in time. They had hoped that this might drop this year to annually, but that hasn't happened so the status quo remains.


....
Just checked the text from the AGM presentation. It was 6 monthly, and remains so:

"Significant in 2019 will be the first reduction and relaxation of reporting obligations under the post-authorisation
commitments as agreed with the European Medicines Agency (EMA). Instead of safety analyses being performed
every six months to populate periodic safety update reports (PSURs), CLINUVEL will now be allowed to supply the
EMA with these reports once per annum, together with an Annual Report. Our teams are working to reduce the
burden to physicians and patients who literally spend hours recording diaries and transferring these data in the
European EPP Disease Registry with very little added value."

However, Wolgen seemed confident the drop in reporting would occur, and it hasn't. I can't imagine that this is anything to do with an actual safety concern, else we'd have heard about it! I'd rather imagine (speculate) it's more to do with the change in Rapporteur who, perhaps, just does things differently to the prevoius one.

Message to Clinuvel: why has this change to annual reporting not occured when at the AGM PW was confident it would? It was touted as a "significant" development. What has changed? It would be very useful if you had a functioning IR department which responded to "significant" questions like this. You are a A$1bn mkt cap company and knocking on the door of the ASX200. You can do better than this!
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Frogster
Posted on: Jan 31 2019, 09:10 AM


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Disappointing receipts number.

Having said that, with sales only ocurring in one region from one product the impact of any variation in payment timing can be very significant. Hopefully that's all we have going on here. It'd be very useful if CUV published some kind of data that helped us understand just how much is a timing effect, and how much might be reflective of underlying trends i.e. tell us average days outstanding for invoices, number of product orders/prescriptions etc etc. Simply saying yeah, there are seasonal and timing effects doesn't help all that much.

Admin and corporate costs at over A$1.033m were A$300k more than predicted. That's probably your extra FDA NDA#2 costs Johnny H.

Manufacturing costs were only A$593k for the quarter versus an expectation of A$1.3m. My guess is that these costs were avoided since the US launch is dealyed versus earlier hopes. They're again predicting A$1.32m for the current quarter, so the ramp up is still expected soon......let's hope they get this bit right eventually. All other cash flow guidance seemed inline.

So, a hiccup, but the result from early July is still really the only game in town.
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Frogster
Posted on: Jan 29 2019, 02:17 PM


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Posts: 621

Looks like someone hasn't done their paperwork for a few years.


Attached File(s)
Attached File  3A509622_CUV.pdf ( 230.79K ) Number of downloads: 288

 
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Frogster
Posted on: Jan 25 2019, 10:45 AM


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Posts: 621

Regarding your desire to see use in HDD and the like, I wouldn't be amazed if we saw an occasional off label use under the type of scenario you suggest i.e. an extreme therapeutic need. After all, we already know CUV has allowed off label use in 1 instance - that of a terminally ill CEP sufferer (AGM 2018). It's the cosmetic off label use that's the non-starter at this stage due to the distribution control systems in place in the EU and planned in the US.
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Frogster
Posted on: Jan 25 2019, 07:21 AM


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Wolgen and the board have made it quite clear time and time again they are not pursuing the goals and business model of Epitan, and they have significant voting clout to back this mindest up.

They have set up and are bound to an incredibly tightly controlled distribution system in Europe almost entirely to avoid off label use. They plan to implement a similar system in the US for the same reason.

Off label use for Scenesse in cosmetic applications is a non starter for this management team IMHO.

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Frogster
Posted on: Jan 23 2019, 06:40 PM


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From S&P/ASX Australian Indices Methodology, December 2018:


Investable Weight Factor (IWF)

Investable Weight Factor = 1 - Sum of the % held by strategic shareholders who possess 5% or more of issued shares.

All issues in the S&P/ASX indices - with exception of the All Ordinaries - are assigned a float factor, called an Investable Weight Factor. The IWF ranges between 0 and 1 and is an adjustment factor that accounts for the publicly available shares of a company. A company must have a minimum IWF of 0.3 to
be eligible for index inclusion. The company’s adjusted market capitalization determines an equity issue’s relative weight in the index.

S&P Dow Jones Indices identifies the following shareholders whose holdings are considered to be control blocks and are subject to float adjustment:

1. Government and government agencies;
2. Controlling and strategic shareholders/partners;
3. Any other entities or individuals which hold more than 5%; excluding insurance companies, securities companies and investment funds;
4. Other restricted portions such as treasury stocks.

IWFs are reviewed annually as part of the September quarterly review. However, any event that alters the float of a security in excess of 5% will be implemented as soon as practicable by an adjustment to the IWF.

The function of the IWF is also to manage the index weight of foreign-domiciled securities that quote shares on the basis of CDIs. Due to the volatility that is displayed by CDIs, unusually large changes in the number of CDIs on issue could result. Where this is the case, the IWF may be used to limit the effect of unusually large changes in the average number of CDIs (and, thereby, limit the potential to manipulate this figure). Where the Australian Index Committee sees fit to apply the IWF in this manner, the rationale for the decision will be announced to the market. This will be reviewed annually at the March-quarter index rebalancing date.

Your "long term holder" label isn't mentioned here by S&P/ASX. The closest similar would appear to be the strategic shareholders/partners label, which I'd interpret as commercial cross holding type arrangments rather than retail investors who happened to get in early and hold for a long time. So, unless you have 5% or more, yours should be included too as should most others held via nominee accounts or, for that matter, directly. On the above description, Lagoda should also be included.
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Frogster
Posted on: Jan 22 2019, 06:21 AM


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My spreadsheet is telling me A$7.0m.
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Frogster
Posted on: Jan 10 2019, 07:20 PM


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A further indication (XP?)
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Frogster
Posted on: Jan 10 2019, 09:51 AM


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Nice start to the year. 👍
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Frogster
Posted on: Dec 12 2018, 05:51 PM


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I understand the logic for the Dec 31 date you've quoted, but I'd note that the AGM slides put validation and decision on priority review as calendar year 2019 items.
I guess, if "satisfy(ing) these latest regulatory requests" (Nov 5) does not equate to actually resubmitting the NDA (if that's how things happened), that might explain how things could slip into next year.
I hope we get a PDUFA date this calendar year, but even if we don't, according to AGM timelines we should see the third indication and CUV103 results in this current calendar year.
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Frogster
Posted on: Dec 8 2018, 10:13 AM


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This is now a moot point - and I'm not sure if you're saying you don't think they got an RTF or if you're saying we should simply move on from questioning if they did or didn't - but if it's the former, then in my reading of it I don't think they actually stated they didn't get an RTF.

As you have quoted below, they stated that "no major outstanding issues....would lead or need to lead to a refusal to file". To me this still leaves room for a minor issue (or issues) which could, and perhaps did, lead to an RTF.

The reason the point is moot is because they have clearly also stated they have now "provided answers to each individual question to satisfy these latest regulatory requests", and I don't think there's any room for interpreting that in any other way than to understand they have answered whatever questions the FDA had and, making an implicit assumption support by this and other statements, things are rolling again.

My best guess is that they:

- got an RTF on minor issues only
- answered the issues quickly
- refiled, and we're now in the 2nd validation period

I cannot see another way that CUV statements and actions around this issue fit with my understanding of FDA processes.

I think, come an assumed filing acceptance and PDUFA date, all this will become a minor historical hiccup, and just another example of the sometimes frustrating lack of precision and explicit clarity that CUV communications bring. Less than perfect clarity from CUV is nothing new to any of us who've been around here for a while. If we get an FDA approval within the next 10-12 months, I expect I'll be happy with the result even if I've had a few grumbles along the way about how we got there.
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Frogster
Posted on: Nov 26 2018, 09:38 AM


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The incidence of inherited porphyrias in Europe (2012) by George Elder, Pauline Harper, Michael Badminton, Sverre Sandberg & Jean-Charles Deybach put the number, based on incidence, at 286.
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Frogster
Posted on: Nov 21 2018, 03:18 PM


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Well, what is there to say about the AGM 2018?

Not much of any great note. I don’t think I really learnt very much new, neither good nor bad. We know CUV is a company that doesn’t hype itself, and that was on display in spades. We’ve seen before that PW’s style and M.O. is one of caution. No Elon Musk type hype from this guy, ever, in my expectation. That’s neither good nor bad I guess, it’s just the way it is, and it’ll never change.

In no particular order:

Aspects of the presentation were historic in nature, and struck me as a new way of presenting old information. I guess there will always be an element of this in an AGM presentation. Regarding forward looking stuff, PW was very limited in his commentary. He cited confidentiality arrangements, and really gave no “update” on key issues of NICE or the FDA. I didn’t get the sense this was for any negative reason, but rather due to an abundance of caution.

If last years AGM saw an expansion of detail on expected milestones, timelines and events, then this year saw a reversion to the default position of saying as little as possible. I’m note sure if that was due to being a little burnt by the things they “missed” doing in the last year, or whether it was due to the current hiatus with the FDA putting everything in hold. A bit of both probably. If it wasn’t already obvious that the last newsletter, which saw PW answer minimally some key questions we’ve had (i.e. where’s the OTC gone?), then it became very clear that was done to head those questions off at the pass prior to today.

Vitiligo: some reasonable time was spent on this. CUV103 was announced as being almost ready AGAIN. How many consecutive AGMs is that now? 3? 4? 5? They must surely have some insight on the data by now, and to keep mentioning it must suggest the data is good (to me at least). It seems obvious they are just waiting for the time to be “right” before revealing. When is “right”? FDA progress on EPP is my guess.

Brief presentation by Blijdorp. He talked a bit about his long running history with CUV, about his belief that people make the difference in companies, and why he spent up big to take his stake. As per his section in the A.R., this seemed to be another stage is introducing him to us. It did nothing to reduce the view that he’s being lined up as the next Chair after Stan finally retreats from the stage. As a very successful businessman Blijdorp is due respect. His reserved, unflashy presentation style appears similar to that of PW.

Prof Minder from Tremli said a few words. She’s administered over 1,300 implants. To her patients, and in her professional view, the product works, and has only minor side effects. Nice to hear first hand what we already have read from many locations. In fact, I’m sure I could hear a low level background chant of along the lines of “safe and effective” being piped over the PA throughout proceedings.

Japan/Australia in EPP was presented as having the same pipeline status as the US. Does that mean an application has been lodged? Sorry, not clear on that.

On the disclosure question below, there are two different things in play. PW mentioned that the company will continue to report quarterly cash flows (the 4C), even though we know they now probably don’t have to. He also stated separately that the frequency of reporting safety data under the Post Authorisation safety protocols to the EMA drops from every 6m to every 12m. Two very different things obviously.

Much flasher location than last year, and particularly the year before. I don’t know that there were many more attendees than previous years. Maybe a few, but not that many. Flashy ceiling to floor screen on the stage, but not helpful to have annotations and translations lost at the bottom of if by the back of the head of the person in front of you.

Overall, if you didn’t make the trip over, you didn’t miss much. Nothing major new bad. Nothing major new good. FDA is the only real game in town, and there’s nothing new to add to that just now.

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Frogster
Posted on: Nov 19 2018, 09:24 AM


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I believe a number of the usual suspects will be attending.
Regarding Q&A, the allocated time has never been a limiting factor. Historically not all that many questions have been asked - perhaps up to 8 or 9 - and some might suggest not all that many have been answered either.
In the context of significantly more comms effort this year, it will be interesting to see if they take a more generous, engaged approach to the answers this year.
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Frogster
Posted on: Nov 16 2018, 03:11 PM


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Didn't he say early Christmas present for 2019? It wouldn't rule out early 2019, but I'm pretty sure those were his words.
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Frogster
Posted on: Nov 14 2018, 03:43 PM


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Posts: 621

Thanks so much for posting.

He seemed to be smiling alot more than he usually does at the AGM.
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Frogster
Posted on: Nov 12 2018, 03:01 PM


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Is the Walnut paid too much? A rather simplistic analysis, but for what it's worth:

https://simplywall.st/stocks/au/pharmaceuti...stay-motivated/
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Frogster
Posted on: Nov 5 2018, 02:16 PM


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Also, hopeful NICE will engage in a managed access scheme and the delay in the OTC product line was due to issues at a supplier - now hopeful of launch in the New Year.

Furthermore, some defence of the Chairman against those who were critical of his comment that the further FDA questions were antcipated before the NDA.
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Frogster
Posted on: Oct 30 2018, 06:58 PM


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I've been on the road these last few weeks, and not been following in detail (probably just as well). Have they actually said they've submitted the extra info, or have they only said fda hasn't commented on time lines? I know this was the case when they announced the initial delay (throw shade at the fda, but hide from the fact a large part is 100% down to them) but I wasn't aware that the first stage to solution (to answer the query) had been reached. I sure hope it has!
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Frogster
Posted on: Oct 15 2018, 07:35 PM


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Probably just 10 of us checking in 9,000 times each.
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Frogster
Posted on: Oct 12 2018, 07:39 AM


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Anyone who owns CUV shares is entitled to attend. Doesn't matter how many or how few. It's a bit more murky for CLVLY and UR9 holders. Some have (I believe) been denied entry previously, and CUV has not enterred into a dialogue (as far as I know) about how to arrange entry for these holders. I suppose a CUV holder might be able to nominate someone as proxy to vote their shares (or perhaps just 1 of their shares). I don't know if being a proxy also entitles you to ask questions.
In the past they have never been recorded, broadcast or transmitted. Doubtful that will change - you have to be in the room.
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Frogster
Posted on: Oct 12 2018, 07:16 AM


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Wouldn't it be handy if the answers to those extra 2 questions and resultant acceptance of the NDA coincided with the AGM where we might just be asked to vote on the NEXT performance rights plan?
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Frogster
Posted on: Oct 4 2018, 02:32 PM


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Posts: 621

Clearly Lagoda has sold a bunch of shares on the market, but this announcement also highlights that Richard Bayles has left Lagoda and, seemingly, taken a bunch of accounts (Brown Brothers, JPM, State Street, US Trust, Wells Fargo) with him.
It looks like he might have gone to Oppenheimer, and presumably they will now be managing these shares instead.

Lagoda loosing the mandate to run these funds looks to be a bigger factor in them ceasing to be a substantial holder rather than quantum of the listed disposals (which I only added up by eye).
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Frogster
Posted on: Sep 26 2018, 10:30 PM


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Posts: 621

$40 share price (or more) might be possible in that time frame with positive fda news, 2nd indication, good cuv103 results, asx200 etc. etc., but I don't expect we'll be seeing A$94m annual revenues and A$76m earnings in a reporting period that closes 9 months from now. I'm very excited by what's finally going on, but I'm trying to keep some realism about how the business is likely to progress. Remember this is CUV. Between hares and tortoises, they have a very hard shell.
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Frogster
Posted on: Sep 26 2018, 09:49 PM


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I'm not sure what you mean by 1,200 "confirmed patients".
If you mean patients being continually treated today, that sounds pretty high to me.

In the recent 4E and the NDA submission announcement from 25/6/18 they pointed out the data set submitted to the FDA (i.e. pretty much everything the know about the drug) encompassed "nearly 6,700 afamelanotide doses administered to more than 800 patients" and in more recent presentations they've been talking about >7,900 doses and >975 patients in 34 clinical trials.

Of these 800-975, this includes many from trials in regions which are not currently reimbursing the product and it's not all patients in trials for EPP alone. I don't think CUV has given an official number of current EPP patients, but if revenue is circa A$26m annually (FY17-18), and approx treatment cost E70k*1.62 then that equates to a current patient population well below 1,200. A few hundred at present it would seem. Sure, we can hope for growth here, but it will take time.

I'm not saying there isn't the prospect of strong growth over coming years, especially with a US approval, but I think we're quite some way from A$94m revenue on European EPP alone.
Totally agree with the growth drivers you've listed thereafter.
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Frogster
Posted on: Sep 22 2018, 05:28 PM


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Maybe they'll correct "Clivucel" too rolleyes.gif .
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Frogster
Posted on: Sep 22 2018, 03:08 PM


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From yesterday:

https://scrip.pharmaintelligence.informa.co...n-Drug-Scenesse

It won't let me start a free trial for some reason. Can anyone else access the interview and share it here?

Damn. Beaten by odi01.
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Frogster
Posted on: Sep 21 2018, 04:11 PM


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A casual 576,000 shares traded for the day, with another 540,000 still (currently) showing on the bid.
A happy weekend to one and all longs.
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Frogster
Posted on: Sep 21 2018, 04:05 PM


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Interesting post close market depth!
I guess this is a pre ASX300 inclusion thing.
Will be interesting to see how the post close auction pans out.
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Frogster
Posted on: Sep 20 2018, 10:03 AM


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PW emerges.
Attached File(s)
Attached File  02024364.pdf ( 1.73MB ) Number of downloads: 169

 
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Frogster
Posted on: Sep 11 2018, 07:42 AM


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Posts: 621

39,328 share trade at 18.462 showing on CHI-X already today. I wonder if that's a hangover from yesterday, or genuinely from today.
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Frogster
Posted on: Sep 10 2018, 01:53 PM


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At the current share price our mkt cap is bigger than 6 companies currently in the ASX200.
Just saying.....
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Frogster
Posted on: Sep 8 2018, 07:41 AM


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Hi Peter. Welcome to Sharescene. That must be the most liked first post ever on this forum!
Thanks very much for your research on CUV - it's very much appreciated.


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Frogster
Posted on: Sep 5 2018, 07:31 PM


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I've just been putting together some similar thoughts to you Mauricinho. I was typing this whilst you posted your view:
I've been trying to get my head around where we are in the application process, and I must say I've now worn a nice neat circle in my carpet.

On 23/8 CUV88 posted the following link:

https://www.fda.gov/downloads/AboutFDA/Cent...s/UCM218757.pdf

This is an FDA desk reference guide (a 59 page summary) to the CDER process for reviewing NDAs dated Sept 2014. It's a few years old, but I can't find any updated process so let's assume it's current. It highlights all the dates by which FDA actions must take place, and what those actions mean.

The bulk of what's relevant today is between p17 and p21, though Appendix A is also very useful. Points to note:


1) Preliminary FDA decision on Priority/Standard review designation is made by Day 14 after application receipt. (Appendix A)

2) Priority/Standard review designation is confirmed at the Filing Review which will take place by Day 45 for Standard review or by Day 30 for Priority review. (Appendix A & p17)

3) At the Filing Meeting there are 3 potential decisions (p20):

a. File the application (no major omissions or deficiencies, minor issues may exist)

b. Potentially RTF the application (correctable deficiencies exist, if they are fixed by Day 60, the application is filed)

c. RTF (deficiencies cannot be rectified readily)

4) For filed (accepted) Priority reviews a "Filing Notification" letter will be issued by Day 60, along with a "No Filing Issues Identified" letter by Day 60, or a "Filing Issues Identified" letter between Day 60 and Day 74. (p21)

5) For filed (accepted) Standard reviews a "Filing Notification" letter will be issued by Day 74 along with a "No Filing Issues Identified" letter or the "Filing Issues Identified" letter. (p21)

6) "Program" Review Timelines for filed applications will be submitted by Day 74 i.e. FDA communicates ongoing timelines promptly. (Appendix A & Section 3.3)

7) - If an RTF decision is taken at the Filing Meeting, an RTF letter will be issued within 60 days. An RTF ends the review process. The NDA will have to be resubmitted with deficiencies addressed and will be considered a new application, or they can be "filed over protest". (p20)

So, what does all this mean about where Clinuvel is in the application process? If we consider that Clinuvel has made a single NDA application on 22 June, then the FDA will have made its Priority review decision at the Filing Meeting held within 30 days of that. If CUV is telling us no Priority Review decision has been made, then I cannot see how that can be the case for a "still live" NDA made on 22 June. There appears to be no process "pause" button, no "extension" process which can push back the Priority Review decision. It seems that at this stage the 22 June application is either filed, or it is not. If it is not, then CUV has had an RTF letter, which it would have had by Day 60 – 2 weeks ago (Continuous Disclosure anyone?). If we've had an RTF letter, then that application is dead - apart from if they've filed under protest, but then a Priority Review decision would've been made - and another application will have to be made.

If it is filed, then CUV would've been informed by the FDA of its review status either way.

So, the only thing to me that makes sense is that they've had an RTF letter and will need to resubmit the entire NDA with corrected deficiencies. If no resubmission has yet occurred, then of course no further timelines can possibly have been provided by the FDA. If a resubmission has occurred, then the timelines are known. I don't think we currently have an NDA in front of the FDA.

If this is the case, then it's at best a pretty disingenuous release today. At worst it's highly misleading.
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Frogster
Posted on: Sep 5 2018, 02:55 PM


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So, this is frustrating as all hell. So many, as usual, unanswered questions.

-Is it a formal RTF or not? We don't know.
-Or, has the application in fact been validated? Not clear, but it would appear not.
-Has the review "clock" started yet? Subject to the above my guess is no.
-How can this happen after such long-term intimate FDA contact? Well, apart from incomptence somewhere in "our" process I guess it's hard to say.

I get that the FDA might not have shared timelines to the PR decision once the inadeqacies are covered, but there is no acceptable excuse for not sharing with us timelines to submitting the relevant data. Heads should roll, but of course they won't since they like carrots but seem to be fresh out of sticks. Where is Wolgen in all this? It seems like he's terrified of putting his name to anything other than "Newsletters" these days - he's always putting up someone else to make the commentary. Very odd.

Having said all that, "product manufacturing information" and "details from the Europen post-authorisation use of Scenesse" sound, hopefully, easier to address than questions around efficacy or safety.

It's a bump in the road, but hopefully not a Blues Brothers style incomplete freeway.
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Frogster
Posted on: Sep 5 2018, 12:12 PM


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"Through diligence and integrity we advance and serve the people."
Is this becoming another countdown clock?
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Frogster
Posted on: Aug 31 2018, 05:07 PM


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Well, what a nice way to head into the weekend.
RC, if you still read this board, drop me an email at frogsterfrogsterfrogster@gmail.com please.
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Frogster
Posted on: Aug 30 2018, 10:09 AM


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You might be right ultimately - there's certainly no compelling operational reason to stay domiciled here. If our speculation about Blijdorp becoming chair is correct then 3 of 4 known directors themselves would be domiciled outside of Australia. Personally I'd expect any exit to be staged. I'm not sure CUV will ever be paying a fully fraked div anyway!
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Frogster
Posted on: Aug 30 2018, 09:49 AM


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Indicators from Clinuvel? Yes, most assuredly. See the post by Investek a page or so back, quoting the preliminary financial report.

What we now know is that a succesful listing on an overseas exchange is a bonus trigger for the CFO, with an execution date of 30/6/2019. If that date isn't met, then of course his bonus terms might be rolled over, but at the same time it hints something could happen in fairly short order.
Any NASDAQ listing would surely have ownership rights, and voting rights too in all probability. What would be the point of it otherwise? There'd be no real change from the current status quo otherwise. A NASDAQ listing would not neccesarily mean the CUV listing would disappear - dual listings are nothing unusual. I'd expect each shareholder would be given the option to keep current holdings/convert as they so desire. The paperwork would be trivial to the share registrars.

There could be a NASDAQ listing with no capital raise, but to me that would be a missed opportunity. From a post I made just over a year ago:

**********
https://listingcenter.nasdaq.com/assets/initialguide.pdf

Page 6 in here (from Jan 2017) suggests we'd fail to meet the criteria for the top tier NASDAQ Global Select Market, but p8 and p9 suggest we meet the Market Value Standard criteria for the second tier NASDAQ Global Market or the third tier NASDAQ Capital Market. Depending on the FY results in a few weeks, we might also meet the Income Standard for both these tiers very very soon. So, NASDAQ might work.

As we've discussed on here before (what seems like years ago.....), the following scenario once again looks plausible.

If management were able to go to the US as:

a) a cash generative, debt free, profitable company, with
b) a product already approved in the EU, and
c) a US NDA/approval for EPP in place/pending, looking for a
d) US listing alongside a capital raise, to fund
e) phase 3 US vitiligo trials, supported by
f) strong CUV103 trial results

then it could be a compelling story. As an aside, in just checking my notes from the last AGM, PW was asked about the possibility of a US listing. His answer suggested this was likely only if true corporate value was not reflected in the share price.
**********


List on NASDAQ and raise funds for phase 3 vitiligo trials is quite likely in my view. We still wouldn't meet the listing criteria for the Global Select Market (1 more year and we probably would), but I think we'd qualify on the Global Market and Capital Market tiers as of now.
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Frogster
Posted on: Aug 29 2018, 07:13 PM


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Totally.
Plenty of institutional fund investment mandates require that investments are only made in dividend paying shares.
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Frogster
Posted on: Aug 29 2018, 05:43 PM


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Interesting that there is, for the first time, an introduction to the remuneration report by the chair of the remuneration committee - Mr
Blijdorp. The text is below.

I wonder why they might do this? Is it an attempt to "introduce" him and his thinking to us ahead of Stan steping down within the year? It strikes me as unusual to go into his thinking in as much detail as they have without some objective behind it. Blijdorp for Chairman seems quite likely to me.
In terms of content, it's interesting that he likes companies he's involved in to have up to 20% of equity in executive management hands. Also he want PW to stick around through to 2021. Also, he hopes to announce a new contract for PW before year end.
I think that means we can expect PW to be offered another chunky share package at the AGM.



INTRODUCTION BY THE CHAIR OF THE REMUNERATION COMMITTEEChairman of the Remuneration Committee: Mr Willem Blijdorp
“I regard my duties as Chairman of the Remuneration Committee as paramount to the wellbeing and longevity of the CLINUVEL group. From the current position of the Company it is imperative for me and my fellow Board members to look ahead and plan for the next few years for the Company to grow and thrive further.
In providing the objectives of the Remuneration Committee and its approach to executive remuneration, I briefly share my professional background and outlook which has taken me where I am professionally today.
As Chair of the Dutch-publicly listed B&S International, a global leader in trading and logistics, I am used to operating in markets which are often tested by changing legislation, new tariffs and where pressure on pricing is experienced. To navigate these challenges, I have always chosen the most successful leadership teams based on a set of fixed criteria. In my opinion, company executives need to demonstrate strong leadership skills, have an ability to roll up their sleeves, and be able to articulate to the Board of
Directors periodically their realistic vision for the company for the years ahead.
Above all, I regard the success of a company as a direct reflection of the intelligence, insistence and integrity of the management teams. In this sense, the key management personnel and the company executives can make or break a company, seldom its services or products, and it is the daily quality of the managerial decisions made by the top people at the helm which matter, nothing less in my books.
In addition, I want to see in the executive management in all companies with which I involve myself to have a sizable ownership by executive management – in cases up to 20% – to make sure that their objectives are aligned with the 80% owned by other shareholders. This approach has provided me and my shareholders the success I enjoy today, and as Chairman of the Remuneration Committee I am supporting the same criterion when it comes to CLINUVEL’s leadership team.
In line with the objectives set by CLINUVEL’s Board of Directors, the task of the Remuneration Committee, as explained in greater detail in this Remuneration Report is to:
1. secure the services of excelling management;
2. align the key performance indicators of executive management with those objectives set for the group of companies;
3. evaluate the performance of executive management against
a) internal performance criterion;
b) international benchmarks in context of this sector;
4. strive for business continuation and sustainability through retention of staff.

I use this very approach also to assess the attitude and performance of the CLINUVEL key management personnel and its company executives with an eye to grow the Group in the coming period. In July 2018, I invested significant sums of my own capital in CLINUVEL, I have a clear interest to continue the success story of this biotechnology venture.
In all the conglomerate of business enterprises I lead, my motto has remained simple: “people work for people”, and this holds true for Dr Wolgen and the team around him. In order to succeed in markets where great challenges are expected and met, you need in business execution what I call “eccentric leadership”. In Dr Wolgen we have this and it needs to continue for another three years, through to 2021, to meet all CLINUVEL’s objectives. While I am certain others could do the job, in my position as Head of the Remuneration Committee, I wish to see continuity for the next term, focus to be sustained, meaning zero distraction from the end game.
What is said about the CEO also goes for the steady and reliable financial management by the CFO in overseeing the Group of six companies globally and containing the Company’s management of costs. The profitability of CLINUVEL is largely owed to the work of Mr Keamy, hence our strong wish to prolong the CFO-CEO axis.
Lastly, we have agreed that the Acting CSO, Dr Wright, will remain as key management personnel while training and providing a basis for succession planning of the next generation of scientific management.
Overall, as Chair of the Remuneration Committee I make a periodic assessment of the operations of the Group. In this sense, I do wish to see continuation and no disruption to the CLINUVEL business to maintain enterprise value at a time where the US market beckons, European distribution grows, new products advance, and the growth of managerial talent is taking place under the leadership of the Managing Director.
Since initially attending a CLINUVEL shareholder meeting in Melbourne in early 2006 I have witnessed – first from distance, and since 2015 as a Board member – how this Company has plotted and manoeuvred around buoys along its voyage.
At multiple cross-roads the Board of Directors has had the choice to intervene or take a more passive attitude towards top management when it came to decisions such as opting to license out the lead technology, sell it off early, or retain it to develop it to today’s success. Other key decisions involved, for example, the financial management of the Group, whether to make larger investments in R&D, pursue multiple indications at the same time with one or several technologies, and raise more capital. As a Non-Executive Board member I have an advisory role but am personally more in favour of steadily building the Company and staying in control of our own destiny. While I try to share my strategic vision with current management of CLINUVEL I stay away from imposing too strong views, however I am extremely content with the way we perform.
The quality of CLINUVEL’s decisions rested on the depth of analyses of the executive management teams giving me and my fellow Board members the confidence that CLINUVEL would navigate and sail around obstacles to make the Company profitable and sustainable. This is the place where we are today.
As Chair of the Remuneration Committee I focus on corporate results and the Company’s ability to meet the short- and mid-term objectives that are within management’s reach.
The short-term objectives are found in the key performance indicators (KPIs) set for all personnel, and in more specific terms in those of the other executive Key Management Personnel including the CEO. Several of these KPI’s are commercially confidential in nature in an attempt to stay ahead of possible competitors, other indicators are more tailored to general business objectives. The mid-term objectives are directly related to the Group’s objectives to achieve profitability and sustainability, and are captured in Business Generation Incentives.
In my view, the current successes of CLINUVEL are assigned to the vision, leadership and execution of the current management team headed by our CEO and CFO who are responsible for the financial discipline which has led to today’s profitability.
The Company’s mid-term vision is found back in its “2020 CUV Strategy” explained in the 2017 AGM presentation and it provides this Committee with a framework for the corporate objectives for the foreseeable future. Accordingly, these objectives are reflected in the remuneration packages of the Managing Director, CFO, Acting CSO and in the future of other executive Key Management Personnel to be recruited.
In arriving at the executive remuneration packages, we strive to provide overall incentives that secure continuation and no disruption of the business at this critical stage of CLINUVEL. The Committee assesses the criticality of CLINUVEL’s business operations based on the following corporate milestones:
1. US regulatory clearance for SCENESSE®
2. US market entry & distribution of SCENESSE®
3. Continuing successful distribution of SCENESSE® throughout the Europe Union
4. Establishing a European business unit by March 2019 (post-Brexit)
5. New product development of
a) VLRX001, CUV9900
b) complementary OTC
6. Expansion of the CLINUVEL Group.
As the Chair of the Board of Directors Mr McLiesh stated earlier this year in his ‘Chair Letter’, our immediate task is to finalise a new employment agreement with the Managing Director. I hope to be able to report on these agreements by the end of this calendar year.
Herewith, I recommend CLINUVEL’s shareholders the remuneration incentives offered to the key management personnel.”
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Frogster
Posted on: Aug 14 2018, 02:12 PM


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Over the years of being long CUV I've often wondered just how significant our collective tendancy to masochism is.
I guess it's a spectrum.
biggrin.gif .
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Frogster
Posted on: Aug 11 2018, 03:41 PM


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By Farmazutical, from March:

New indication:
I agree with Uho who recently posted on GG that, logically,
the new orphan indication for Scenesse could be XP.
There is no cure for the condition and absolute sun avoidance
is one of the ways to live with XP. Although there are a few known cases
of XP in Fitzpatrick 5 it’s predominantly a condition that affects
lighter skin types. The pathology is different but there are many
similarities with porphyria. Scenesse’s DNA repairing, anti-inflammatory
and melanogenetic properties could very well
alleviate many of the symptoms in XP.

Clinuvel stated recently, that they are seeking regulatory
approval for EPP in Australia and Japan in H2 2018 following
submission of the NDA in the US.

Prevalence of EPP is the same in Japan as in most Western countries.
With a population of 127 million people we can expect <500 EPP patients
in Japan.

XP, however, has a prevalence of 1:20.000 in Japan resulting in
more than 6000 XP cases in that country alone. It makes sense to approach
Japan for EPP with the scope of gaining a label extension approval
for XP shortly after.


Kudos to Farma and Uho. Looks like you could well be right.
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Frogster
Posted on: Aug 9 2018, 02:37 PM


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I guess we'll get to see just how much real intent there is to pay more heed to the patient voice. There's been alot of talk about it. Let's hope the practice and reality stacks up.
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Frogster
Posted on: Aug 9 2018, 07:08 AM


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I hope it makes them feel a whole lot better as I can't see it helps the appeal process very much.
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Frogster
Posted on: Jul 27 2018, 09:59 AM


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http://www.clinuvel.com/investors/news/announcements

Newsletter out.
Not terribly exciting content.
:FDA application......it was a big dossier.....well done all
:Pharmacovigilance.....implant design was important to control distribution channels
:Brexit.....we don't want to have to move from the UK
:Expansion.....product line underway. No substantial detail on launch of new product line (July looking less and less likely!), CUV103 results expected sometime (really?? been expected for about 4 years now!!!), US vitiligo trial depends on US EPP review.
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Frogster
Posted on: Jul 26 2018, 01:52 PM


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We're probably all expecting Clinuvel will announce record quarterly receipts from customers in the next few working days via the 4C quarterly report for entities subject to Listing Rule 4.7B. Does anyone know for sure that they will do this?

By this, I mean release a 4C. I'm certainly expecting the receipts would be a record, but I'm not sure they'll have to release the document.

ASX Listing rule 4.7B is basically a rule that applies to companies with similar cash flow characteristics to oil or mining exploration companies, before they become oil or mining production companies. i.e. the rule provides for enhanced cash flow reporting whilst entities are consumers rather than generators of cash. When companies have changed the nature of their operation to become cash generative, the need to report a 4C drops away.

ASX listing rule Guidance Note 23 (p8, link below) states:
"As a general rule, ASX usually likes to see at least 4 consecutive quarters of positive net operating cash flows before it will lift the requirement for an entity to provide quarterly cash flow reports under Listing Rule 4.7B. To that end:

an entity whose last 4 quarterly reports have all reported positive net operating cash flows will not usually be required by ASX to continue any further quarterly cash flow reports;"

So, as we know, CUV has been net cash generative for the last 4 consecutive reported quarters (bet they squeezed things real hard last quarter to make this happen) and may no longer have the requirement to issue a 4C. The decision to lift the requirement does not appear to be an automatic right, but rather the ASX has the discretion to ask for more 4Cs if it sees fit. Their reporting calender on the Financial Overview page on the website still lists a Q2 4C as due no later than 31 July, but they're usually pretty slack in keeping this page up to date and accurate. I've asked them (CUV) for clarification but as we know they don't often like to engage with us on these matters.


So, I wouldn't be surprised to NOT see a 4C this month, and that means the next results due would be H1 figures due by end August. Of course, before then, we may yet see an announcement on the fabled new product line (states as "expected to be announced in July 2018 following the completion of the NDA submission", and of course we can hope for validation of the NDA on 22 August (4 weeks yesterday).


So let's wait and see what happens, but some advance clarification would be nice. Essentially, if no 4C emerges by close on Tuesday it's not neccesarily a cause for panic!


P.S. Kudos to the member on here who sparked me into looking this up.


https://www.asx.com.au/documents/rules/gn23_appendix_4c.pdf
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Frogster
Posted on: Jul 7 2018, 02:23 PM


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I'm not sure I'm any more qualified to comment here than anyone else, but I've been involved in a few block trades over the years and my speculation on what's happened is as follows:

-block trades are used to shift sizeable positions with minimal market impact. Imagine trying to sell 1.3m CUV on the market! That would be a LOT of average trading volumes days and would doubtless have a substantial negative impact on the price of a very thinly traded stock. The 10% discount to market is what the seller has accepted to mitigate the very real chance that selling piecemeal would drive the stock significantly lower. I don't think the $10 would have been agreed long ago and that this was a long planned trade between 2 known parties, I just think it nicely fits the current interests of both parties. On balance Lagoda has judged it's interests are better served by selling at -10% in one hit rather than being every share on the sell side for a solid 65+ days or trading.


-block trades are usually negotiated at arms length. It's more usual for the buyer to know who the seller is (cause the shares can only come from a holder in size, but anyone can be the buyer) than vice versa. That doesn't mean the seller would never know who the buyer is, but in my experience they may well not. It's not clear to me if this was done through a service like Centrpoint as described by Johnny H, or if it would have been put together the old fashioned way, through networks and contacts. I would speculate the latter, and I wouldn't be surprised if Lagoda got in touch with Stan or the Walnut directly and asked if they knew of any party interested in buying in size......and as it happens it appears they did.


-Why sell now from Lagoda's POV? Obvioulsy could be very many reasons, but I think MrDax is probably right that a big speculative overweight position taken out years ago has just been getting bigger and bigger as the stock has climbed from the $2ish they started buying at to the $11ish of today. A PM has to managed their risk profile, so why not unload a huge heap of risk and lock in a great profit? I don't know what their average cost price was, and I'd guess they're not in a free carry position for their remaining holding, but they have enormously derisked their position. If you are a sizeable holder of stock, you've got to have an exit strategy, and I wonder if the NDA was a pre identified trigger for Lagoda to rebalance. Will be interesting to see if they keep hold of the smaller stake, or if they want to seel a few more.

-the trade was concluded in a closed period, but it was started before the period began. Blijdorp was given permission to conclude a trade in the closed period by applying to do so on 28/6/18. I don't think he knows FDA approval will be given - if he did that would surely be insider trading and for the same reason he probably doesn't have even provisional year end financial data - but clearly has a positive expecation for the company for years to come. I find that very comforting.

So, overall, my speculation is something along the following lines happened: NDA was submitted. Lagoda recognised that as a trigger to rebalance, lock in a profit and derisk. They called Stan to ask if he knew anyone interested in buying a block. Stan said let me check....he asked PW.....who said "Hey, I just might......give us a few days....." After a few days PW replied to Lagoda "Yup....we've got you a counterparty who'll take 1.4m at $9." Lagoda squeezed them up to $10....and the paperowk was finallised in the closed period with CUV ethics committee approval. My guess would be that Lagoda only found out who the buyer was later......but they don't care cause a Director spending that much of his own cash is a tremendous signal for a stock that they still have a big exposure to.
So, that's my speculation....it's a story that for me fits....but I guess we'll never know the facts.
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Frogster
Posted on: Jul 6 2018, 03:18 PM


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That is very good to hear!
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Frogster
Posted on: Jul 4 2018, 03:22 PM


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Yep. And to think they started buying in size at A$2 (or thereabouts).
I wonder if we'll see the other side of the trade. That would be fascinating.
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Frogster
Posted on: Jun 25 2018, 06:44 PM


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Thank you mrdax. I'm on my phone and doing that myself was just too hard.
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Frogster
Posted on: Jun 25 2018, 06:17 PM


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Royco, search my past posts for data on how long its taken in the past for performance rights shares to be issued after meeting a performance condition. From memory its been between a week and a couple of months. There's nothing sinister or unusual in the fact that its not been announced yet.
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Frogster
Posted on: Jun 25 2018, 10:36 AM


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Congratulations to management.

They have variously come in for lots of criticism from many of us, myself included, and they sure have deserved much of it. Having said that, they have today announced something pretty remarkable. One thing we have never criticised them for is their tenacity. That's on show today in spades.

Whilst there's still a long and challenging path ahead, today is a good day.

Well done Dr Wolgen and team.
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Frogster
Posted on: Jun 25 2018, 09:55 AM


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Duplicate. Tooooooo sloooooooowwwwww.
Attached File(s)
Attached File  43w0mgrl4csb10_1_.pdf ( 373.73K ) Number of downloads: 92

 
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Frogster
Posted on: Jun 24 2018, 02:13 PM


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Remember that 924,974 number is the total of performance rights that he holds. They convert to shares on a variety of milestones.

The single biggest one is the SUBMISSION (Seeva) of the marketing application to the FDA. It's a pretty sweet hurdle. Submission only. Not triggered by actual approval or anything commercially important like that.

This is Performance Condition 4 of the scheme that was put to shareholders at the 2014 AGM. You can read the exact phrasing in the AGM explanatory notes. The scheme was renewed at a more recent AGM (last year?). Triggering PC4 nets PW 624,975 shares.

Stan will get 25k shares, same for Brenda and Elie would've got 17.5k.

I'm not sure what the specific events are that'll get Wolgen his remaining 299,999. Strange number that.
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Frogster
Posted on: Jun 24 2018, 12:33 PM


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He wont be getting 5m shares. It's something like 624k shares from memory on submission of the NDA.
3 of the other directors will get a much lower number of shares on submission.
Some of the management will get shares on approval of the application, but the quatum hasn't been published.
There's a huge difference between a trading halt around a capital raising, and the issuance if shares to action an approved reward scheme. I'd be surprised if you ever get a halt for the latter.

If share issuance is involved in this event, it's a secondary item to the regulatory submission.
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Frogster
Posted on: Jun 23 2018, 04:34 PM


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Posts: 621

I found myself wondering in the middle of last night why trade would be halted in Australia and Germany but not in the US?
We know CUV hasn't always dotted every i and crossed every t, but to forget to request a halt would surely be beyond the pale.
Anyway, I did some digging and found the following. It's not that enlightening about the core issue, but it answers some questions I had.

- Clinuvel trades OTC in the US as a Level 1 ADR. It's not an exchange listed security.

- The ADR agreement between Clinuvel and BNY Mellon makes no mention of Trading Halts and how they should be handled.

- According to this page, OTC traded products are regulated by the SEC and FINRA and only they can halt or suspend trading in stocks (I think Johnny H mentioned this a few days back) https://www.otcmarkets.com/learn/faqs

- According to this SEC pdf, https://www.sec.gov/investor/alerts/tradingsuspensions.pdf the SEC will only suspend trading to protect investors and the public interest when there are questions around things like failing to file periodic reports, allegations of insider trading and accuracy of finanial reporting. So, a regulatory submission wouldn't get the SEC to raise an eyebrow.

- According to FINRA, as per this page, http://www.finra.org/industry/faq-otcbb-fr...d-questions#700 FINRA will halt trading of an OTC ADR if trading in the foreign exchange is halted for "public interest concerns" but "FINRA will not impose a trading and quotation halt if the Foreign Regulatory Halt was imposed solely for material news, a regulatory filing deficiency, or operational reasons". So material or operational news will not be enough for FINRA to halt trading on CUV ADRs.

This all tells us nothing about what the underlying reason for the Aus trading halt is, other than to say it's probably material news. What is does suggest is that each exchange/body has appropriately applied it's own differing rules, and that there's no failing by CUV in this.

Personally I think the news in question is simply that the NDA is finally lodged and that some kind of timing issue meant they couldn't announce to the ASX on Friday. I'm imagining a scenario where the submission was completed late Thursday US time, and confirmation wasn't received till Friday in the US, which was too late to publish when the ASX was open. For some reason they thought the news might leak, so they chose the halt to be certain trading wasn't misinformed. If it was something like an RTF, surely an instant ASX release would have been required, in the same way that they were very swift to inform recently of the unhelpful developments at NICE. I guess we'll find out soon enough.

GLTA.
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Frogster
Posted on: Jun 22 2018, 01:41 PM


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Something along those lines makes sense to me.
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Frogster
Posted on: Jun 22 2018, 01:28 PM


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Is anyone else feeling a little distracted from whatever else they should be doing today?
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Frogster
Posted on: Jun 22 2018, 10:12 AM


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Yes, it's re "regulatory submission"


Attached File(s)
Attached File  43vz4mf92z60zj_6_.pdf ( 235.37K ) Number of downloads: 188

 
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Frogster
Posted on: Jun 22 2018, 10:07 AM


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Ooooh.
Trading Halt.
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Frogster
Posted on: Jun 21 2018, 12:56 PM


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Lol.
Demonstrable protection from the shell too!
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Frogster
Posted on: Jun 21 2018, 12:40 PM


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I'm imagining Frilly is infact still on the scene, only he's been reassigned.
He's no longer the frontman.
He's delivering the NDA to the FDA. On foot. One page at a time. And eating a few along the way. Probably.
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Frogster
Posted on: Jun 17 2018, 12:50 PM


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Not sure this update (or rehash) from Friday has been posted here:

https://simplywall.st/stocks/au/pharmaceuti...limited-asxcuv/

and their company report:


https://simplywall.st/stocks/au/pharmaceuti...utm_source=post

This includes a DCF derived target price A$54.61.

I'm not a subscriber to Simply Wall St and I haven't looked at their assumptions in detail but the target price sure is worth thinking about.
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Frogster
Posted on: Jun 15 2018, 04:45 PM


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That high?In that case I'm doubling up first thing Monday! rolleyes.gif
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Frogster
Posted on: Jun 15 2018, 04:17 PM


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10 trading days left till the end of June.
Will they/won't they submit within their latest deadline?
Fingers crossed they finally mange it.
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Frogster
Posted on: Jun 4 2018, 06:00 PM


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Funny? Yes.................but it's Clinuvel.
As to the revenue trigger, I think you might be assuming that all group revenues are made under the EMA, and I don't think that's the case. Special access schemes are not included under the umbrella of the EMA.

Revenues listed under the "Sales reimbursements" P&L line item are the revenues from the Swiss and Italian special access schemes which have been running for some time (though the Italian SAS ended in 31/8/16).
Those listed under "Commercial sales" are those made under the EMA approval (to the Netherlands, Germany, Austria and, since 1/9/2016, Italy), and these have only been generated since the first commercial sale was announced on 21 June 2016.
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Frogster
Posted on: Jun 4 2018, 11:56 AM


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Minus Sinus, I don't think this means they have changed the terms of the award for Directors. I believe what this shows is that Directors will get their big slug of shares on submission of the dossier as before, but that executives and other staff will get some shares when approval is granted. They've combined in this list the conditions attached to different schemes pertaining to different levels of function, and not all conditions apply to all schemes. That's why condition B says "not attached to Non-Executive Directors" i.e. it's not a condition that applies to their award.
My guess is that this share issuance is triggered by condition E or F.
The recent regulatory update stated Vallaurix is "working to establish an appropriate formulation of afamelanotide", so it could be that.
As for the 10m figure, the trigger is EURO 10m, not A$. In 16/17 commercial sales, which I'd interpret as those made under the EMA approval (as opposed to under other special access schemes), were A$11.9m which is approximately Euro 7.7m. With growth into the current season that Euro 10m hurdle could now have been breached but I'm not sure it previoulsy would have been.
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Frogster
Posted on: May 29 2018, 09:23 PM


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http://www.clinuvel.com/social-media/subq/such-tweet-sorrow

Are anyone's ears burning?
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Frogster
Posted on: May 29 2018, 04:35 PM


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Hi Stan,
Could you give us that in German, Swahili, or perhaps Latin please?
TYVM.
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Frogster
Posted on: May 25 2018, 11:54 AM


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Clinuvel promised 3 scientific communiques in April and May.
Only 1 published so far. May is obviously not over yet, but it's cutting it a bit fine.
I wonder if they will be delayed along with/because of the NDA and topical launch?
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Frogster
Posted on: May 17 2018, 12:15 PM


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http://www.aspecthuntley.com.au/docserver/...&popup=true

Lagoda must have thought so too.

Turns out they've been selling in dribs and drabs since November 2017.

Who's doing the buying?

German retail spruiked by Mr Homm?
New insto?

Interesting times.
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Frogster
Posted on: May 16 2018, 12:33 PM


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p41 of the AGM slides indicates Q3 Asian "Launch CLINUVEL skincare solutions 2 distribution channels" which - hopefully - does actually relate to an actual commercial launch of an actual product. Actually.

You may very well be wise in taking a low expectation view, but if this "launch" isn't in fact a launch, then we'll have another example of failed communications to gripe about. I hope we don't get another. We already have enough I think.
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Frogster
Posted on: May 14 2018, 01:36 PM


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My guess is the work experience lad can't cope with writing 2 press releases at a time.
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Frogster
Posted on: May 14 2018, 08:36 AM


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NDA expected before 1 July 2018.

Safety data all good.

Haven't read the rest yet.

Have read it now:

5100+ implants
4000+ implants to EPP patients
99% patients remain on treatment
Latest PSUR raised no new safety issues
No off label use has occured - the controlled distribution works
Some Swiss patients have had over 50 implants over 12 years
New saftey data is now incorporated in the NDA, with final submission of the dossier expected before 1/7/2018
First complemenatary non-prescription products/follow on products due to be announced in July following the NDA (I guess 20 May no longer applies)
Work on paediatric Scenesse is underway.
Attached File(s)
Attached File  01980973.pdf ( 97.21K ) Number of downloads: 164

 
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Frogster
Posted on: May 12 2018, 06:59 PM


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Did the walnut not say by (not on) the 20th? Can't check right now, but that's what i recall.
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Frogster
Posted on: May 11 2018, 07:38 PM


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It sounds somewhat unethical to me.
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Frogster
Posted on: May 1 2018, 01:59 PM


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Maybe it looks a bit low on the face of it but you wouldn't take shares, presumably with some lock up agreement, unless you thought they were going to be worth more at and beyond the point the lock up expires.

A typical lock up period might be a year. A lot of good stuff is widely expected to happen in that time frame.

Equally, if you thought a lot of bad stuff was going to happen in that time you probably wouldn't take shares would you?

I'd expect Biotech Lab to be better informed of what's going on on the inside than any of us here.
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Frogster
Posted on: Apr 30 2018, 11:25 AM


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FWIW my thoughts are that for the weakest seasonal quarter, these are a decent set of figures. I was expecting slightly negative cash flow (-A$720k) so to see them generate A$230k from operations is pleasing Cash generateive all year round? I like that.

Virtually all of the uplift came from Receipts being better than I'd anticipated (A$3480k reported vs A$2500k expected). A fairly big FX effect obviously flattered the cash balance, but there's little you can do to control that inthe long term.

Other points I thought were interesting:

- Q4 Advertising spend antcipated to be 2nd highest in their history
- Product manufacturing costs expected to set a new high in Q4, having today set one in Q3
- Staff costs in Q4 are expected to remain high af A$1640k. That would be the 2nd highest quarter in Clinuvel history (the highest being Q1 this year). Q1 is normally high due to bonuses, so I wonder if Q4 is related to staffing up, or a continuation of the highish level seen this quarter (long term personnel related payments)
- Can't remember the CFO ever making a statement on the 4C before. I'm pleased to see they are beginning to discuss things a little more than they used to.
- "developing and delivering treatments for patients with a RANGE of severe genetic disorders" Mmmmm. Expansion.

Obviously the top line isn't going to grow dramatically till more markets come on line (especially the US) but as the company works towards that goal, these strike me as a pretty reasonable set of figures.
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Frogster
Posted on: Apr 22 2018, 12:56 PM


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Clinuvel has only ever referred to the figure in that classy new logo as Diana.

Diana (daughter of Jupiter and Latona) was a Roman goddess, whilst Artemis (daughter of Zeus and Leto) was the Greek version of a similar character. I guess whether they actually can be coinsidered as interchangeable depends on whether you are Greek or Italian (then probably no) or from elsewhere (then probably yes).

Would it therefore be inconsistent to trumpet Diana in the logo, then expand a product line under Artemis branding? In my opinion, probably yes. Would this worry Clinuvel? In my opinion probably no - I don't think they thought that deeply about the rebrand in general, so if they didn't think about this aspect either I wouldn't be surprised.

Anyway, maybe that's enough moaning about the logo and perhaps it's time to enjoy the recent share price action instead.
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Frogster
Posted on: Apr 17 2018, 11:57 AM


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At least they've dropped the Latin in the motto on the instagram channel.
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Frogster
Posted on: Apr 6 2018, 03:36 PM


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You may well be right, but my guess is that this was done by the current graduate trainee.
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Frogster
Posted on: Apr 6 2018, 01:55 PM


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What a great way to attract long-term fundamental investors by making the first analyst report you publicise in 5 years one where fundamentals are barely mentioned, fair value isn't discussed at all and the entire research theme is based on stoking speculative takeover froth!

On the one hand I'm pleased to see the company crank up the communication efforts a little. On the other it's really disappointing to see they still have the learner wheels well and truly bolted in place.
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Frogster
Posted on: Apr 5 2018, 06:30 PM


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Indeed there was. From 8/3:


Just for reference:

Performance Condition 1 was met on 28/11/14, and the 3B (New issuance) and 3Y (Change in Directors interest) notices were issued on 4/12/14 i.e. 6 days

Performance Condition 2 was announced as met on 23/12/14 and the 3B and 3Y notices were issued on 23/1/15 i.e. 31 days

Performance Condition 3 was announced as met on 22/6/16 and the 3B and 3Y notices were issued on 4/8/16 and 5/8/16, i.e. 47/48 days

If history is any kind of guide, when Performance Condition 4 is met, it might be 1 to 7 weeks before the statutory ASX announcement is made.
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Frogster
Posted on: Mar 24 2018, 10:45 AM


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I'm not so sure.

The minutes of the meeting held 14/2 refer to the IR panel convened on 23/1, the outcome of which would be presented at the next meeting (to be held on 14/3).

Seems to me that the 22/3 Welsh government ratification of the recommendation not to use in NHS Wales was made after the IR panel result was presented last week.

If this really is the final word in Wales (at this stage) it's not pleasing, but probably not that surprising either. It just reinforces that FDA approval is the critical factor right now.
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Frogster
Posted on: Mar 19 2018, 09:27 AM


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In the AGM presentation, on page 40, the EPP expert meeting SCENESSE evaluation was listed as the 3rd European & Australian milestone for the year. To my eye the data point sat in roughly April/May, so it appears to have happened early.

p40 of the same presentation showed that the FDA decision on Priority Review should occur almost simultaneously with the expert meeting.

Whether or not this is significant depends, I guess, on your view as to why the expert meeting seems early: genuinely brought forward? AGM timelines intentionally inaccurate/indicative only? Can you draw parallels between the regional milestones at all?

Anyway, time will tell, but it's good to see stuff happening broadly as planned this year.

EDIT: I think my post ties in with ajshare's comment. Reporting on the PASS data is only supposed to happen after the final FDA module is submitted. Looks to me like the NDA is done. New shares for PW soon?
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Frogster
Posted on: Mar 19 2018, 09:05 AM


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http://www.aspecthuntley.com.au/docserver/...&popup=true
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Frogster
Posted on: Mar 16 2018, 03:29 PM


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Nice finish to the week.

Last time we had volumes like this for a few days was back in November when the share blew through 7.00 and went on to 8.50 in short order and peaked a little over 9.00.

I wonder if we have a case of bigfigureitis?
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Frogster
Posted on: Mar 8 2018, 08:42 AM


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Just for reference:

Performance Condition 1 was met on 28/11/14, and the 3B (New issuance) and 3Y (Change in Directors interest) notices were issued on 4/12/14 i.e. 6 days

Performance Condition 2 was announced as met on 23/12/14 and the 3B and 3Y notices were issued on 23/1/15 i.e. 31 days

Performance Condition 3 was announced as met on 22/6/16 and the 3B and 3Y notices were issued on 4/8/16 and 5/8/16, i.e. 47/48 days

If history is any kind of guide, when Performance Condition 4 is met, it might be 1 to 7 weeks before the statutory ASX announcement is made.
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Frogster
Posted on: Mar 2 2018, 06:47 AM


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624,975 shares to Wolgen + circa 65k to the rest of the board.

Page 21 of the attached document.

Details announced on day of EMA approval 27/10/2014.
Attached File(s)
Attached File  CUV_Notice_of_Annual_General_Meeting_Proxy_Form.pdf ( 665.02K ) Number of downloads: 100

 
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Frogster
Posted on: Feb 21 2018, 01:24 PM


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Posts: 621

So it seems that the logo and the motto have, generally, gone down like a bucket or warm sick with those of us who've expressed an opinion. I'm guessing that we are, on the whole, offering our views as human products of Western economies and cultures. I'm wondering if the branding that is so jarring with us is, infact, designed to target another region?

We know that in the next few months we're expecting to finally get the CUV103 results (around April), focused on an Asian phenotype. We're also expecting to see details of the complementary product lines and markets served (May 20), the launch of the Analytical Lab in Singapore (around June), and the actual launch of the skincare solutions range in Asia (around Aug).

So, maybe, we're witnessing a pivot to Asia? Maybe Europe/US is just too hard? Maybe the logo is designed to capture the imagination of, say, the Chinese market? I don't know, but maybe Asians have a different response to logo graphics than we've mostly had. Does anyone have any views/experience of that? Do Asians seek different visual clues from a logo to Westerners? Perhaps the Southern Cross was included to emphasis the Australian origin of whatever products come to market and as we know in some product areas (i.e. baby formula) the Chinese seem to perceive Australian product as quality. Wild speculation on my part, but who knows?

If this is the case then it begs the question of what are the implications of turning a cold shoulder to Western sensitivities, but that's a question for another day I think.

Another thing that might possibly fit the framework is this Giles Delaney column thing. Apparently he's worked for papers and mags in Asia Pacific for 30 years. I've tried to do the normal searches you do for people these days, and I can't find any details on him or his experience whatsoever. Has anyone else been able to establish his credentials? I'd love to know the terms of his engagement. Editorial freedom yet his only contact point is a Clinuvel email? Seems like an unusual arrangement.
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Frogster
Posted on: Feb 20 2018, 07:06 PM


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I'm hoping this is simply a mechanism to prove they act on their Values statement.

Under Approach they state "We admit errors recognise our shortfalls, evaluate, analyse and learn to implement new findings."

Next week they're going to bin that graphical mess, roll out a decent new one and say "See, told you so", aren't they? Aren't they???


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Frogster
Posted on: Feb 20 2018, 05:45 PM


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Clinhope, the motto is at the bottom of EVERY page on the website.
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Frogster
Posted on: Feb 20 2018, 04:19 PM


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Since we can see the Southern Cross constellation in the logo, we can assume that the goddess of the moon is hunting at night.

What's a frilled lizard doing out at night? They're diurnal - they are not active at night.

Doesn't that send the message if you take our products you can go out at night? Shouldn't it send some kind of message that you can go out in the day? That you get protection from the sun? Why does Clinuvel want to be associated with the moon and the stars. Don't EPP patients want to get away from living a nocturnal existence?

Beyond it just looking amateur, isn't there a massive logical flaw in this combination of characters?
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Frogster
Posted on: Feb 20 2018, 12:54 PM


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Guys, guys, guys.....forget the lousy logo.......we've got a motto IN LATIN!!!

Nothing says disruptive, forward looking, innovative, technology led growth company than a motto.....on every page of the website......IN LATIN!!!


/I used to think it'd be a shame to see the company taken over. I'm beginning to think it'd be more of a mercy killing now.
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Frogster
Posted on: Feb 20 2018, 11:42 AM


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Yep.....kudos to you Investek for finding the Artemis/Diana website and link back in October. My, they must have been spitting feathers after you hit the Submit Post button.

I agree about the logo. Diana, frill neck lizard, AND the Southern Cross. Way busy.

A quick review of the site shows much of the same content as before. A few new bits here and there. I thought this was interesting:

http://clinuvel.com/social-media/monthly-viewpoints

It's a page where the journalist Giles Delaney wrote a column about branding. Apparently it will be monthly column:


"*This is the first column in a regular series about the big issues that affect CLINUVEL and the broader biopharmaceutical sector.

Giles Delaney is an experienced business journalist, having worked for newspapers and magazines in the Asia Pacific for more than three decades. As a guest writer, Delaney retains full editorial freedom and his views are his own. Delaney is happy to answer readers' questions via mail@clinuvel.com. Answers will be posted on the CLINUVEL website."


So, a third party will answer questions about Clinuvel, but still no indication that the company will do so itself. Seems like a half arsed attempt to set the discussion agenda to me. As an aside, anyone know if Delaney's father used to work for Clinuvel somewhere along the line?

Anyway, enough whingeing from me. Everything is OK because WE NOW HAVE A MOTTO IN LATIN!!!!!

PER DILIGENTIAM SINCERITATEMQUE PROGREDIMUR ET POPULUM SERVIMUS

I was worried that we didn't have one, but I can sleep easy now. If only they could combine that with the countdown clock in someway then things would be perfect!
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Frogster
Posted on: Feb 19 2018, 08:57 PM


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Hope ≠ expectation.
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Frogster
Posted on: Feb 19 2018, 11:41 AM


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New website due tomorrow. I wonder what joys it will bring? Hopefully a transparent, comprehensive window into the company, its operations, strategy and potential.
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Frogster
Posted on: Feb 13 2018, 10:51 AM


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That is the most useful newsletter that I can remember seeing from Clinuvel. Not exactly straight talking, but much more so than other recent efforts.
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Frogster
Posted on: Jan 31 2018, 09:17 AM


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Second consecutive quarter of receipts down compared to prior year...not by much, but down.

R&D costs a fair % lower than expected, but next quarter expected to be a fair bit higher. Timing of FDA NDA related stuff perhaps?

Admin and corp costs higher than expected, but productions and operating costs well below company expectations (once again....they often over estimate these costs).

Not sure what to make of this bit:

"Cash receipts are expected to fluctuate in the following quarterly reporting periods, reflecting the timing of customer payments following sales orders received for SCENESSE®"

Are they indicating that timing effects will benefit the next quarter, that they will negatively impact the next quarter, or are they simply telling us that sales are not the same as cash timing? Odd thing to say IMHO.


New director initial interest release out:

http://www.aspecthuntley.com.au/docserver/...&popup=true

2,900 ordinary shares held.
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Frogster
Posted on: Jan 31 2018, 06:50 AM


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It's been like that for at least a few weeks. I was on there perhaps 3 weeks ago, and I'm confident it was like that then.

As an aside, wow, doesn't time fly? Mr H has been General Manager of Clinivel UK for 10 years and 3 months already according to his profile. I never would have thought it was that long since he moved to the UK. blink.gif
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Frogster
Posted on: Jan 30 2018, 06:24 PM


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Learning on the job for young executives.....to an extent I can see some sense in that, as long as it's balanced by some who know the ropes.

Directors learning on the job?.....no thanks. They should be experienced, qualified and independent.

The board needs to challenge the executive. There needs to be a creative tension where the strategy and execution needs to be constantly challenged.

We will now have a board where 2 directors have served for over 9 years which means, under the board charter, they should not be considered independent, one who is experienced in privately held luxury and fmcg and now a Dr seemingly with no commercial board experience but a strong family connection to the group. I see her LinkedIn profile has been updated to say that she has joined Clinuvel to "Serve at the request of the Board as a Clinical Endocrinologist". We need one of them on the Board? If one was needed, surely a consultancy role would do? Wouldn't the board be better served with someone with product roll out experience in the US?
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Frogster
Posted on: Jan 30 2018, 07:59 AM


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She left Wyeth in 1994.
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Frogster
Posted on: Jan 25 2018, 12:53 PM


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Yes, I know.

It's the implication by the company that they are the same thing, along with the refusal to clarify that they are not the same thing when clarification is requested, that is misleading.
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Frogster
Posted on: Jan 25 2018, 11:45 AM


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Posts: 621

If a lawyer wanted to get involved in these questions, I think they might have some fun.

The 2017 AR states on p54 that ordinary shares are quoted on all ASX member exchanges under CUV, and that shares (as opposed to securities, which might carry different rights to shares) are also quoted under UR9 and CLVLY. So, on that basis, the company implies that CUV, UR9 and CLVLY represent the same fractional ownership - that they represent the same thing - and presumably, therefore, that they have the same entitlements.

In the 2017 Corporate Governance statement, on p5-6 the company responds to Principle 6 - Respect the Rights of Security Holders of the ASXCGC CGPR. CUV claims to comply with recommendation 6.3, that "A listed entity should disclose the policies and processes it has in place to facilitate and encourage participation at meetings of security holders". CUV's response to this recommendation is:

"The Company encourages full participation of shareholders at the AGM to ensure a high level of accountability and discussion of the Company’s strategy and goals. The AGM exists, among other things, to promote shareholder communication by providing shareholders an opportunity to ask questions to Directors at the time of meeting. Directors are expected to make themselves available to meet with shareholders at the AGM. The external audit firm partner in charge of the Company audit is available to answer shareholder questions at the AGM. Shareholders who are unable to attend the AGM or other general meeting may submit questions and comments before the meeting to the Company or the external auditor (in the event of an AGM). Also, shareholders are permitted by the Company to vote online and by other methods prior to the AGM if they are unable to attend."

So, on the one hand UR9 and CLVLY are shares that rank alongside CUV, but on the other no facility is given to enable them to vote online if their holders cannot attend in person which means the statement they made above is inaccurate. At best, therefore, management's treatment of holders of UR9 and CLVLY is ambiguous, and at worst it's highly misleading.

Of course, questions around eligibility to vote with UR9/CLVLY or to attend the AGM could easily be answered by the company, but for some reason they choose not to.

For me this just smacks of another example where governance of CUV falls short. We already have the Chairman and another board member who have served for more than 9 years which, by the terms of the board charter, means they cannot be independent, which adds to the fact that several of the board participate in the performance rights scheme at least in part by virtue of the fact they provide executive functions. Again, according to the board charter, executives of the company cannot be independent.

Personally, I won't lose any sleep when Stan steps away from the Chair. He's failed to address these issues which have been in the background for some time. Hopefully the next Chairman will clean this mess up.
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Frogster
Posted on: Jan 24 2018, 12:25 PM


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Posts: 621

Clinuvel Remuneration Committee take note:

http://ir.tesla.com/secfiling.cfm?filingID...HTM_TOC524719_5

This is how to align executive interests with those of shareholders and customers.
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