Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome To The ShareCafe Community - Talk Shares And Take Stock With Smart Investors - New Here? Click To Register >

4 Pages (Click to Jump) V   1 2 3 4 >

macgyver
Posted on: Yesterday, 10:57 AM


Group: Member
Posts: 681

40k performance rights have lapsed and forfeited. Yay! A small win for the shareholders..
  Forum: By Share Code

macgyver
Posted on: Yesterday, 10:41 AM


Group: Member
Posts: 681

In what circumstances does this occur? At the request of the applicant? Strange.
  Forum: By Share Code

macgyver
Posted on: Dec 5 2019, 07:12 PM


Group: Member
Posts: 681

Eloquently put😉
  Forum: By Share Code

macgyver
Posted on: Dec 5 2019, 06:13 PM


Group: Member
Posts: 681

Would you capitulate at $50? After you stuck in there and gave it to the FDA day after day? I don’t believe it..
  Forum: By Share Code

macgyver
Posted on: Dec 5 2019, 11:28 AM


Group: Member
Posts: 681

Yeah good point. Things did take a turn for the worse when he said he’d turned bearish. It snowballed from there. Anyway he’s done and dusted. Here at least, but as Verhaven pointed out he’s in the Yahoo asylum. Maybe he’ll return here as HonestGuy3000 or something🙄😆
  Forum: By Share Code

macgyver
Posted on: Dec 5 2019, 11:10 AM


Group: Member
Posts: 681

Once again, I don’t even know what you’re taking about bro.... Take 2 pills and call yourself in the morning Doc.


Edit. Getting you banned won’t do the sp any favours I’m afraid🤪
  Forum: By Share Code

macgyver
Posted on: Dec 5 2019, 09:13 AM


Group: Member
Posts: 681

LH was relentless, he sprouted a new head and became maniacal. Admittedly, even if I didn’t like his posts, I was surprised he was banned. I wonder how it bodes for others who refute claims here or disturbs the atmosphere of the board as it were. Kinda got ‘Lord of the flies’ in the end...


Edit: Market has taken kindly to LH getting booted. Who else can we boot to keep the momentum going?🤣🤣🤣
  Forum: By Share Code

macgyver
Posted on: Dec 4 2019, 11:12 AM


Group: Member
Posts: 681

Agreed. The threat is real and PW should respond accordingly.
  Forum: By Share Code

macgyver
Posted on: Dec 4 2019, 08:45 AM


Group: Member
Posts: 681

Is it safe to say Clinuvel has become re-risked again? It’s just a feeling, but the shorts are playing a dangerous game. If a cascade of good news comes through they will get walloped.
  Forum: By Share Code

macgyver
Posted on: Dec 3 2019, 02:20 PM


Group: Member
Posts: 681

Yeah ok, that wasn’t my intention. In fact I was hoping for the opposite, to point out some good fortune coming Clinuvel’s way. I’m concerned you’re an A-grade cynic, but that would be very cynical of me...
  Forum: By Share Code

macgyver
Posted on: Dec 3 2019, 11:38 AM


Group: Member
Posts: 681

Great, another long time follower posting for the first time in 15 years of reading this board. They are coming out of the woodwork!
  Forum: By Share Code

macgyver
Posted on: Dec 3 2019, 04:14 AM


Group: Member
Posts: 681

I don’t believe large long term investors would be responded to with a letter from the CEO, rather they would probably be spoken to in person or through an employee of Clinuvel who is in the know. The CEO letter is a response to retail investors; it is more than coincidental that the letter contains sparse opinion about the sp fall and shorting action. It’s a direct response to concerns here on Sharecafe, the retail investor as it were. He has previously responded to our concerns before, indeed the parting letter from Stan Mcleish spoke of the behaviour of perhaps overzealous investors who “lack the graciousness” to respect Management’s actions, or something to that effect. I don’t think that was aimed at large institutional investors.

Scenesse has already been approved, and it will receive approval for DNA repair also. This will take less time to achieve, actually it will most likely be approved for this before MT’s drug will be approved for EPP. Photoprotection may be 10+ years away, but DNA repair approval is likely to be much closer given Scenesse’s approved status.
  Forum: By Share Code

macgyver
Posted on: Dec 2 2019, 04:22 PM


Group: Member
Posts: 681

PW mentioned Scenesse for DNA repair. 3rd indication? Shouldn't take long,....
  Forum: By Share Code

macgyver
Posted on: Dec 2 2019, 10:32 AM


Group: Member
Posts: 681

Interesting to note PW was dismissive of OTC non-pharmaceutical products claiming DNA repair.
  Forum: By Share Code

macgyver
Posted on: Dec 2 2019, 09:48 AM


Group: Member
Posts: 681

Nice find my good man. It does raise questions though about how MT was able to obtain fast track designation. Perhaps it’s a first past the post system, whoever gains approval first gains the upper hand. Would MT have to wait seven years before releasing their drug on the market?
  Forum: By Share Code

macgyver
Posted on: Dec 1 2019, 11:43 AM


Group: Member
Posts: 681

Fair enough. LevelHeaded2000, I apologise. I will exercise restraint, and reserve judgement privately regarding your assertions. GLTA, and roll on the US rollout, the only near future event that matters.
  Forum: By Share Code

macgyver
Posted on: Dec 1 2019, 03:11 AM


Group: Member
Posts: 681

And you used it to support your assertion. Well done.

Me: No ACTUAL DNA repair products whatsoever.

L.H: Yes, they do (claims cosmetic companies have an ACTUAL DNA repair product).

L.H: I'm sure their formulations are B.S.

Me. Lol.

  Forum: By Share Code

macgyver
Posted on: Dec 1 2019, 02:39 AM


Group: Member
Posts: 681

After reading that comment I understand now you seeking to support your statements with false assertions. No cosmetics company is able to achieve DNA repair. Enzymes?? You’re not serious surely. Its generally well known that cosmetic companies thrive on manipulating consumers into believing that their products benefit them. If you look at the ingredients list on the back of any cosmetic product, you can see it is a mix mash of a vast array of chemicals, oils and general rubbish. I suppose the main difference of concern here would be none of these products would have a melanocortin as its primary active ingredient.

DNA repair is likely to occur with Afamelanotide or a derivative of it. A DNA repair product of significance from a cosmetic company is likely to never occur, ever.

It’s completely irrelevant that a cosmetic company is further along in DNA repair research than Clinuvel be it an enzyme or something else. They simply don’t have something that will fundamentally aid in repairing DNA, let alone skin cancer. I’m in disbelief also that a cosmetic company would not find add on value from waiting a company like Clinuvel. If Clinuvel has something that cosmetic companies have long been searching for, it seems to be a complimentary fit.

P.S supporting your statements with random Google searches in the spur of the moment and coming up with articles from WIRED doesn’t look good. I was expecting some peer reviewed scientific paper but alas, I come across a non scientific article from a somewhat insignificant website that specialises in, electronics perhaps? Give it up shorter.
  Forum: By Share Code

macgyver
Posted on: Dec 1 2019, 01:59 AM


Group: Member
Posts: 681

Cosmetic companies have no actual DNA repair products whatsoever, nor any other company in the world for that matter. Suggesting there would be no add on value for Estée Lauder or any other company aquiring Clinuvel is a completely false statement, and a denial of the potential for Scenesse to become the world’s first DNA repair drug. As you say, cosmetic companies are about marketing and persuasion, they thrive in the psychology of pseudoscience. Can you imagine a cosmetics company having a product that, for the first time in history, actually provides what the cosmetic companies have consistently lied about? That’s rather compelling, and suggesting that no cosmetic company, let alone any other company, would not have add on value comes across as a deliberate attempt to deflate Clinuvel’s prospects.

As an aside, I agree that Clinuvel is much better positioned when in control of its products, EXCEPT for distribution. To achieve widespread market penetration the yoke will have to come off and allow Scenesse to be accessible to a larger population, of which it will not be achieved through the glacial process of receiving new indications.

Even if Clinuvel doesn’t have a product specifically for DNA repair as yet and is still some time away (unless Scenesse IS the DNA repair product), having aspirations to develop for DNA repair is certainly attractive to the right company, and we both know companies have been acquired for gestating pipelines that are years away from fruition.
  Forum: By Share Code

macgyver
Posted on: Nov 30 2019, 04:56 AM


Group: Member
Posts: 681

Your continual worship of PW is noble, but your ray of sunshine estimations of an imminent sp rise of 3-5% are not.

We are down 35-40%? from all time highs so I can why 3-5% increase could get your motor running.

Have you noticed the sp was still trending down yesterday?

Don’t you worry yourself about this, more pain is still to come.

P.S. I’ve been watching CSL share price, it is on an absolute charge at the moment. Something to wish for...
  Forum: By Share Code

macgyver
Posted on: Nov 30 2019, 04:51 AM


Group: Member
Posts: 681

Still waiting for LH’s positive aspects of his SWOT analysis. A few weeks ago we would have been inundated with reasons why we should stick with Clinuvel. Now, we are inundated with conjecture about a drug that is 3-4 years away from being a direct threat. Shorts have increased to approx 7%...
  Forum: By Share Code

macgyver
Posted on: Nov 29 2019, 04:23 AM


Group: Member
Posts: 681

A complete 180 degrees on the dilution. Now you’re calling it theft when you tried to assuage people’s concerns that it was insignificant in the big picture. This you done a few times, urging people to move on. Now you’re a broken record stuck on the MT drug who can’t seem to move on from that. Follow your own advice perhaps?
  Forum: By Share Code

macgyver
Posted on: Nov 28 2019, 07:02 AM


Group: Member
Posts: 681

How effective is the MT drug? What does “generally” mean? Is the mode of delivery as effective as an implant? How do you know a pill taken everyday is more likely to be convenient than a once every 2-3 month implant? Will a pill taken every day cause more nausea than a slow release implant? What is the psychological impact of potentially increased nausea from a pill mode of delivery? Will patients be inclined to forego the pill when travelling overseas and instead look to the implant for convenience?

There are many questions and what if’s about this threat, and we both know nothing about how patients will take to the drug when it arrives at market (no earlier than 2022-23), and I could go on about what if’s. For what it’s worth, I think it’s unproductive to continually assess this threat in a negative light. Do we sell now? Are the shorters into something? What has changed in your view regarding the shorts? Have you reassessed your investment regarding them? Looking at all the variables is tantamount to counting grains of rice. I’m going to take a deep breath and hold for the time being, there is still good news and developments to come for Clinuvel. This you surely can’t deny...

P.S. Interesting to note the shorts increasing....
  Forum: By Share Code

macgyver
Posted on: Nov 28 2019, 04:50 AM


Group: Member
Posts: 681

You’ve made a few assumptions about Clinuvel’s prospects concerning US rollout, as you did when chastising NewToCli about selling out (which appears to have been very savvy indeed). That’s fair enough, and again I agree with a lot of your comments. But your analysis is plumbing new realms of what ifs that are just far too removed to be of immediate concern.

You haven’t considered vitiligo or DNA repair as bulwarks to MT’s threat. No, MT will not be able to provide therapy to vitiligo sufferers as they will need adjuvant creams to assist with patchy lesions. You haven’t considered Clinuvel’s response to the MT threat, in which all it would take is for PW to allow Scenesse to be used off label, thereby allowing saturation of the US market and providing enormous revenues before MT even get their foot in the door. For myself I will see what happens in the coming months (no pun intended), but I can assure you I’m no cheerleader for PW. Some would argue the opposite. Let’s read your positives from your SWOT analysis, surely it must be more than safety??
  Forum: By Share Code

macgyver
Posted on: Nov 27 2019, 07:55 PM


Group: Member
Posts: 681

Bro, take two pills and call the doctor in the morning. You’re all over the shop. You’re no longer analysing, you’re jumping at shadows. Are you short?
  Forum: By Share Code

macgyver
Posted on: Nov 27 2019, 07:37 AM


Group: Member
Posts: 681

Market exclusivity only denies generics for the same ingredient having market access for the allotted time period. I don't think it can stop other companies developing drugs for the same specified condition (EPP), especially if the drug's formulation and active ingredients are different to afamelantotide.
  Forum: By Share Code

macgyver
Posted on: Nov 27 2019, 03:20 AM


Group: Member
Posts: 681

I agree with a lot of your comments. As unsavoury as they are to long investors, you are right to point them out. With a seemingly imminent threat on the horizon, I can only imagine PW will have to change tack and his damned insistence about controlling distribution and off label use. Taking a pill for other skin afflictions will, along with ease of availability, be extremely convenient enabling the drug to be accessible everywhere. A stark contrast to having nominated medical/expert centres in a few locations.

An elaborate IP structure has been set up around Scenesse over the years by PW so as to protect and increase longevity of profitability for the drug. Then MT swoops in with a pill that looks to do exactly the same as Scenesse. A little frustrating considering some effort has gone into this. I believe though that what Clinuvel has to protect itself is the different formulations that will be difficult for the MT drug to compete with. How effective these are remains to be seen. I regard PW as extremely competent when it comes to strategic thinking, whereas his operations management skills are somewhat stilted. I’m in no doubt he has accounted for the MT threat, is there room for two in the market? I think so, but the effect on Clinuvel will be pronounced and most certainly in profitability. The MT drug is at least 3 years out from becoming a direct threat to Scenesse, probably longer. I understand MT is a huge company with considerable resources and experience with lobbying government officials, but they cannot push timetables any shorter. This reality is in Clinuvel’s favour, and perhaps this timetable was one of the impetuses to drive forward Clinuvel’s program to meet the performance rights target of $7.5billion MC within 3-4 years before MT’s arrival on the scene.

I sincerely believe from this point on, we will see a full assault from Clinuvel. Anything less will be detrimental to the viability of the company.

Many thanks to Frogster for his AGM commentary. An interesting read as always, hope the holiday was restful and rejuvenating.
  Forum: By Share Code

macgyver
Posted on: Nov 26 2019, 06:51 PM


Group: Member
Posts: 681

Dr Wally, you’ve put my mind at ease. I totally agree that pills compared with an implant is laborious. Birth control implants have made life a lot easier for women, set and forget for three years (Scenesse won’t last that long obviously). So I consider the Mitsubishi Tanabe drug less of a threat but certainly a competitor. However, Clinuvel will be more focused on building a skincare brand that will MT will not be able to compete with, nor would they want to.

By the time this threat drug is ready to market, Clinuvel will be streets ahead. But this threat is a healthy reminder that one should always scan the horizon and not fall into complacency regarding their investments.
  Forum: By Share Code

macgyver
Posted on: Nov 26 2019, 03:12 PM


Group: Member
Posts: 681

This MT drug from Mitsubishi Tanabe, can it be used to treat variagate porphyria? What about XP? I understand it’s a partial MC1 agonist but perhaps for these other conditions Scenesse still has an advantage. This drug eitherways is undoubtedly a threat. But I’m hoping it gives PW a rev up to spur some action quick smart.
  Forum: By Share Code

macgyver
Posted on: Nov 26 2019, 11:10 AM


Group: Member
Posts: 681

Someone’s NXXT the shit out of the stock today😴
  Forum: By Share Code

macgyver
Posted on: Nov 25 2019, 03:53 AM


Group: Member
Posts: 681

The strategic mistake (if any) will be in not utilising the war chest to fund R&D. I didn’t accept PWs explanation about organic growth and how having money in the bank supports the sp. Yes I agree dilution and debt can, in extreme overly indebted/diluted situations, negatively impact on the sp (Palatin), but increased expenditure in the right way pays for itself in short order. Given the threats having presented themselves to this board in the last month or so, commercialising Scenesse for EPP is a huge priority as far as I’m concerned. Nothing else is generating cash so any perceived dithering there leads to frustration and dismay. The war chest should be used to propel vitiligo forward, 3rd indication should go straight to DNA repair, and then off label use for every skin affliction there is.

We have seen PW being cautious with everything up till this point, and we dot know him in any other light. How well will he execute long gestated plans going forward, and will he be dynamic and nimble enough to change his approach? It remains to be seen.
  Forum: By Share Code

macgyver
Posted on: Nov 25 2019, 03:41 AM


Group: Member
Posts: 681

Someone who says sell your shares must be after cheap shares.

“I’ve been an investor since 2006, but I feel I must speak up after 13 years of reading this board because all this talk about PW’s rights package is hurting my feelings. Sell your shares because it’s a free world, but don’t criticise PW because....um......it’s not a free world!”

Hilarious.
  Forum: By Share Code

macgyver
Posted on: Nov 24 2019, 06:03 PM


Group: Member
Posts: 681

Interesting how some discussion about PW’s generous rights package generates a multitude of responses from those IDs with less than 5 posts (which don’t really discuss anything else and only come out when PW is perceived to be under attack). I mean, how many IDs does Malcolm Bull have??
  Forum: By Share Code

macgyver
Posted on: Nov 23 2019, 08:46 AM


Group: Member
Posts: 681

So it was less about manufacturing delays and more about waiting for trademarks to register?
  Forum: By Share Code

macgyver
Posted on: Nov 22 2019, 07:29 PM


Group: Member
Posts: 681

You, bearish???

You, the guy who has been telling everyone not to worry about anything including shorters, sinking share price, PW's antics etc, is now bearish?

This must be tongue in cheek, otherwise you're off your head.

I'm cutting through the crap and focusing on US EPP sales. Everything else can sit in the can until it gets flushed.
  Forum: By Share Code

macgyver
Posted on: Nov 22 2019, 11:06 AM


Group: Member
Posts: 681

The following post by Silverchair at Hot Copper, interesting theory:

“I've tried to put some figures together that would offer a possible explanation as to why Clinuvel is being shorted. My first assumption is that the company is priced cheaply at these levels, and seems to be valued purely for EPP (and cheap just on that indication) when they have so many other potential assets such as vitiligo, topicals, DNA repair, cash in bank, growing profits etc. etc. So why short-sell a company that is already quite cheap (two research reports have valuations of $55+) and has enormous potential and risk for the shorters to the upside? Well lets look at a takeover scenario and here the figures are just an example for this exercise:
If CUV was trading around $40 (and without short-selling IMO it would be at this level at least) and a large international Pharmaceutical or perhaps Cosmetic/Science company wanted to takeover CUV they may have to offer a generous premium to bring the tightly held and loyal register on board - lets say $80 per share is the offer and the deal is done with most people happy. However, if they were trading at $30 or less (due to 3 million shares being short sold as happens to be the current situation) then a takeover offer of $70 a share may well be successful and most people are still happy.
That $10 per share saving in the event of a takeover of Clinuvel (CUV has about 50 million shares) would equate to a saving for the successful bidder of some $500 million. The 3 million short sold shares sold at an average price of $30 and then closed out at takeover price of $70 per share for a $40 loss per share would mean the shorters lost $120 million! Now if the short sellers just happened to be associated with the successful takeover bidder then the loss would be consolidated with the savings made due to a cheaper takeover and they would still be at least $380 million better off due to this strategy, which is a decent chunk of change and well worth the manipulation. So if this scenario did happen to play out it must be legal or our regulators would crack down on it cough cough but it would probably not be in the best interests of this country due to lost wealth and lost capital gains taxes.”
  Forum: By Share Code

macgyver
Posted on: Nov 22 2019, 03:58 AM


Group: Member
Posts: 681

No unfortunately, funds are a little sparse having done a Johnnytech and thrown in the kitchen sink as well.

One thing I’ve noticed is that this year’s AGM seems to have gone down with a whimper. Not much enthusiasm and excitement has been generated, particularly with the revelation of the DNA repair development. What should’ve been an auspicious day has been remembered by the performance rights package, and to a lesser degree perhaps not much to report given we are 2 years away from the next approved indication. I’ve been waiting for Frogster to graciously share his thoughts on the AGM as I have the last couple of years, but I suspect even he has shifted in his regard for Clinuvel management at this point in time.

Striking how threats to Clinuvel have suddenly (seemingly) manifested themselves, I can think of no other greater motivation (besides the performance rights package) to spur PW to expedite and execute all plans post haste. Yet if the US rollout takes more than 6 months to rollout to first US customers I would consider that a lesson not learnt from the European rollout, and downright annoying. $1.8 million is already set aside for US operations, no excuse then?
  Forum: By Share Code

macgyver
Posted on: Nov 21 2019, 05:50 PM


Group: Member
Posts: 681

Dr Wally hyperventilates quite a bit. Did he mention this drug is safe? No mention of the FDA though. You have been spared🤝
  Forum: By Share Code

macgyver
Posted on: Nov 21 2019, 02:48 AM


Group: Member
Posts: 681

What is the actual dilution going to be? Is it 3%, 8%, or 10% as Willem Biljdorp mentioned in the AGM (courtesy of Frogster)?

Skin cancer prevention is no doubt very lucrative, I’m curious as to how it will come to market. Is it something you put on before heading out into the sun, or is it something you apply when you get sunburned, or both? Since this is essentially a new medical domain being created, Clinuvel will truely be a pioneer if all works out according to plan. Sure, this molecule has been around for a long time, and there are many products on the market (OTC) that purports to heal skin damage (L’Oreal pseudoscience), but this will really be the first commercially available product ever that will repair DNA damage. It’s hard to get my head around..

If this is the endgame, it must also mean that this product, however it arrives, will also be applicable to numerous disorders I’m guessing. If it is Scenesse in a bottle, then HHD, pemphigus vulgaris and other afflictions can be treated as well. THAT is the endgame I think, not just a skin cancer preventative. Once this is out, Clinuvel’s development pipeline will come to an end as there will no affliction left to cater for (big call yes, different iterations no doubt but most skin disorders could be alleviated with a single product). One lotion to rule them all...
  Forum: By Share Code

macgyver
Posted on: Nov 20 2019, 12:11 PM


Group: Member
Posts: 681

Obviously management will see this as a protest vote, surely one of the highest against votes of recent times. It matters nought, its carried and in play. Better work hard for the money PW...
  Forum: By Share Code

macgyver
Posted on: Nov 20 2019, 10:07 AM


Group: Member
Posts: 681

I need someone to distillate what's being espoused in the presentation.

So far I'm looking at:
- Scenesse Enfance in a somewhat extremely thin needle,
- Two Vaullarix products to assist with vitiligo treatment,
- lotions (suncreams) for prevention of sunburn and repair of DNA damaged skin
- CUV9900 for 3rd indication?
  Forum: By Share Code

macgyver
Posted on: Nov 20 2019, 09:49 AM


Group: Member
Posts: 681

Uh, did PW just name one of the Valluarix molecules after himself? (phimelanotide) biggrin.gif
  Forum: By Share Code

macgyver
Posted on: Nov 16 2019, 07:14 AM


Group: Member
Posts: 681

The irony. PW’s sleight of hand regarding rejection of NDA runs counter to the values recently espoused by Clinuvel. The Latin motto should be changed to something we all understand and accurately reflects the ballsy attitude of the man: Who Dares Wins.
  Forum: By Share Code

macgyver
Posted on: Nov 15 2019, 04:01 AM


Group: Member
Posts: 681

Even though I very much appreciate Uhoh’s extensive research and commitment to afamelanotide, he has walled himself off somewhat over on GG. Not a big fan of dissenting opinions, and for someone to opine about a poster here from afar when he doesn’t accept dissent is a case of having his cake and eating it too. But besides that, his work is invaluable and he is somewhat of a savant genius in being able to string together thousands of papers to form coherent theories about possible applications for afamelanotide, which is remarkable.
  Forum: By Share Code

macgyver
Posted on: Nov 12 2019, 10:15 AM


Group: Member
Posts: 681

Mitsubishi Tanabe. It’s the new FDA... graduated.gif
  Forum: By Share Code

macgyver
Posted on: Nov 12 2019, 03:52 AM


Group: Member
Posts: 681

No suprises there, Clinuvel’s operations in Singapore were previously headquartered in an accountant’s office in a rather dated building in North Road. I thought Menlo Park had a nice ring to it, maybe it’s about keeping up appearances, something the sly PW has become rather adept at 👀
  Forum: By Share Code

macgyver
Posted on: Nov 9 2019, 08:04 PM


Group: Member
Posts: 681

Uh, did something happen to this board over the last 12 hours?? Ignoramus is starting to post something resembling a serious post and getting a few thanks for it (and appreciation from X-Ray), Johnny H (a normally level headed contributor) has gone apeshit and threatened to bring PW down, PW has been found out as a shifty European operator, Dr Wally has absconded with his profits, and LevelHeaded2000 is doing his damndest to get everyone to move on from this farce.

We should all get together for a drink and let off some steam. This is far too enjoyable to be moving on from🤣🤣🤣🤣
  Forum: By Share Code

macgyver
Posted on: Nov 9 2019, 12:23 PM


Group: Member
Posts: 681

Agreed. It’s out in the open now and we can see management has been less than forthcoming about a range of issues. The one thing about not telling us the truth about rejection was shareholders didn’t get walloped by the market. It’s now official that PW is a liar, but I’ll give him a pass because he did get us over the line.
  Forum: By Share Code

macgyver
Posted on: Nov 8 2019, 11:16 AM


Group: Member
Posts: 681

Yeah this was pointed out before FDA approval, I’d assumed at the time it was in preparation for imminent US sales, ramping up production logistics etc.

Launch of the OTC product would be overdue but welcome, and a big vitiligo trial would certainly get my motor running king.gif
  Forum: By Share Code

macgyver
Posted on: Nov 7 2019, 09:34 AM


Group: Member
Posts: 681

Touché
  Forum: By Share Code

macgyver
Posted on: Nov 7 2019, 09:22 AM


Group: Member
Posts: 681

Unfortunately the bulk of the buy orders are at $29 and below, fake or otherwise sad.gif
  Forum: By Share Code

macgyver
Posted on: Nov 7 2019, 04:23 AM


Group: Member
Posts: 681

We’ve been told ad nauseum about what Clinuvel is doing right. We know that and we can see it for ourselves. What is also happening before our very eyes is an opportunistic money grab that is constructed with very soft targets except for the $7.5 billion MC. The issue of shares yesterday was appropriate and a just reward for getting Clinuvel this far. What is happening now is an attempt to line up a very quick succession of easily obtainable targets with the knowledge these would be achieved regardless. That’s not a performance incentive, that’s a sham.

Regardless of context and whether the 3% is insignificant or not, this is about what’s right. They could drop all the other incentives and give PW 3% of the company for the $7.5 billion MC. THAT would be incentivising, not an attempt to mock shareholders. It would at least have the veneer of credibility.

I disagree strongly about this being a mountain made out of a molehill. As a forum with members cast far and wide, we can at least protest and try to garner support to oppose the incentives package. Initially I disagreed with Johnny H’s call up for members to vote in the negative, thinking such voting would be insignificant (and most likely will be still). But given the responses here over the last week it certainly seems worth it to try. I suggest focusing less on what is going to happen over the long term and focus instead on what is going to be voted on in two weeks’ time. That’s real and imminent....
  Forum: By Share Code

macgyver
Posted on: Nov 6 2019, 09:18 PM


Group: Member
Posts: 681

It seems the focus is on incentive milestones above anything else at the moment. One shouldn’t be surprised: it looks as if PW is preparing to leave at the end of his contract. With more than a golden handshake....
  Forum: By Share Code

macgyver
Posted on: Nov 6 2019, 09:11 PM


Group: Member
Posts: 681

Astonishing. You have summed my sentiments about everything that’s wrong with the proposed incentives for PW, including my pet bugbear: cash languishing in the bank at the expense of missed opportunities. As I’vesaid before, nothing wrong with raising equity/debt as it will pay for itself in short order, especially if PW is going to get shares for that!
  Forum: By Share Code

macgyver
Posted on: Nov 6 2019, 03:19 PM


Group: Member
Posts: 681

The sp had stabilised somewhat. Now with the shares issue today, 3 Euro countries refusing to reimburse Scenesse, and an impending shareholder revolt, the market has had a gutsful. I do appreciate some fellow members’ optimistic appraisal of the current situation (I’d rather have $45 a share than buying cheap at $29 FFS, isn’t it better to go up than down??) , but $45 to $29 is unusual to say the least. It’s downright frustrating.

I know, I know. It’s coming. 🙄
  Forum: By Share Code

macgyver
Posted on: Nov 6 2019, 03:13 PM


Group: Member
Posts: 681

Well, old mate PW did let the handbrake off. But the car careened down the hill in reverse sad.gif
  Forum: By Share Code

macgyver
Posted on: Nov 6 2019, 09:10 AM


Group: Member
Posts: 681

The handbrake has been on for a month since FDA approval. Will PW kindly take it off now? Thanks cobber rolleyes.gif
  Forum: By Share Code

macgyver
Posted on: Nov 6 2019, 08:55 AM


Group: Member
Posts: 681

Do you know what it was issued for, FDA approval?

Edit: I see it👍
  Forum: By Share Code

macgyver
Posted on: Nov 3 2019, 02:19 PM


Group: Member
Posts: 681

I’d say definitely, and not just instos but a few retail as well. I have a few friends I told about the stock recently. It’s been very difficult to get people to come on board, the change in sentiment was largely due to showing them profit to date. It took that to get some folks to finally come around, and dare I say it might be a similar case with others.

As an aside, it would be extremely easy for PW to get to $7.5 billion MC. Let the drug go off label and I think we will see that target in short order. When I think about that, I begin to wonder if that performance metric is a little soft as well😆
  Forum: By Share Code

macgyver
Posted on: Oct 31 2019, 07:38 PM


Group: Member
Posts: 681

This sucks man. Will France be truly egalitarian and approve reimbursement? thumbdown.gif
  Forum: By Share Code

macgyver
Posted on: Oct 31 2019, 06:57 PM


Group: Member
Posts: 681

Yeah that was something I wasn’t sure of, when the revenue was booked.
  Forum: By Share Code

macgyver
Posted on: Oct 31 2019, 05:52 PM


Group: Member
Posts: 681

Keamy and Bildjorp are getting tricky with their words. Keamy mentioned FDA sales in the quarterly without any indication of more European countries coming online. Surely they must be confident of more sales in Europe? Or is it we will likely see FDA sales before France, Spain and the UK come online? The last quarter had $3 million more than the previous corresponding quarter, and now Clinuvel is $1 million short this quarter.

Plateauing for now I take it...
  Forum: By Share Code

macgyver
Posted on: Oct 31 2019, 08:52 AM


Group: Member
Posts: 681

Its slightly less than the same quarter last year. How is the cashflow, I'm reading $3 mill less?

Seasonal demand aside, I would've expected cash receipts as more patients come online. Perhaps there are more patients but seasonal demand dictates all?
  Forum: By Share Code

macgyver
Posted on: Oct 31 2019, 06:58 AM


Group: Member
Posts: 681

Not sure if PBAC would refuse reimbursement (of course it’s entirely possible). $15 million per annum is not a big deal in the scheme of things. Let’s hope with FDA/EMA approval and PASS data that other jurisdictions will show less resistance to reimbursement.
  Forum: By Share Code

macgyver
Posted on: Oct 30 2019, 09:36 PM


Group: Member
Posts: 681

Its right to gripe about these performance rights, they are excessive and soft.

So this is how I'll be voting:

$5 billion MC will get a NO vote
$7.5 billion MC will get an abstention.
$15 billion MC will get a Yes vote.
$30 billion MC will see me wolf whistling at the next AGM holding a placard of PW with the words "Will you marry me?" wub.gif

By the way, the Chair mentioned that the "funds" have approved everything over the years yet Clinuvel management still believe in the democratic rights and voice of the retail investor. That was lovely, in a thinly veiled threat kind of way....
  Forum: By Share Code

macgyver
Posted on: Oct 30 2019, 02:23 PM


Group: Member
Posts: 681

PW is turning into an animal, he’s given up the Mary Jane and is now snorting coke.👀 Expect Japan application to follow in short order. No time to waste my good man!🎩
  Forum: By Share Code

macgyver
Posted on: Oct 28 2019, 11:06 AM


Group: Member
Posts: 681

Disregard any theory I come up with🤣
  Forum: By Share Code

macgyver
Posted on: Oct 28 2019, 10:22 AM


Group: Member
Posts: 681

I follow, this is the third green day in a row however. Previous sideways action usually came swiftly, as in the next trading day with drops and rises within a $2 price band. Punters getting back in after consolidation and profit taking perhaps.
  Forum: By Share Code

macgyver
Posted on: Oct 28 2019, 09:58 AM


Group: Member
Posts: 681

Daytraders, shorters and others may be perturbed by the special block purchases going through after the auction. They don’t know what to make of it, and neither do I. Except to say, perhaps someone is on the hunt?
  Forum: By Share Code

macgyver
Posted on: Oct 28 2019, 08:37 AM


Group: Member
Posts: 681

Jack Bogle would agree.
  Forum: By Share Code

macgyver
Posted on: Oct 25 2019, 03:47 PM


Group: Member
Posts: 681

Nice. I wonder what's going on here, some shorts unravelling their bets with cheap shares albeit slowly?

Prior to FDA approval when the sp was sideways sliding between $24-26 I didn't see these special block purchases after 4:10pm. I'm expecting more sideways action regardless but at least the bleeding has halted.
  Forum: By Share Code

macgyver
Posted on: Oct 24 2019, 09:39 AM


Group: Member
Posts: 681

And who votes, the nominee? I could be mistaken, but Clinuvel wouldn't know the individual shareholders in those nominee holdings, don't they have to ask specifically to vote?

You're right though, every little bit helps. If Madman votes no, I'll save my proxy forms from the toilet and vote no as well. cool.gif
  Forum: By Share Code

macgyver
Posted on: Oct 24 2019, 08:52 AM


Group: Member
Posts: 681

I received my proxy forms yesterday in the mail. Because I'm insignificant, I'll be using them for a bowel motion later on today. The only ones who can influence the outcome of the vote are the bank nominees in the top ten shareholders list, and they've approved everything to date so far. I'm expecting more of the same.

For what its worth, even though I'd like to see a MC of $7.5 billion, the incentives are too much for one man regardless of how much money he makes us. Besides, the company would meet most of the objectives through normal business practices alone without extra oversight from PW. On the other hand, its good to see PW getting greedy and aiming for maximum dollars. The veneer of ethical grandstanding is making way for the real PW, the cutthroat tycoon.
  Forum: By Share Code

macgyver
Posted on: Oct 23 2019, 02:20 PM


Group: Member
Posts: 681

45 mins until it’s possibly a green day Billy Boots, the tide is turning!!!🤪🤪🤪
  Forum: By Share Code

macgyver
Posted on: Oct 23 2019, 09:38 AM


Group: Member
Posts: 681

Yes!

Well, it could be that Clinuvel decided to wait for FDA approval to bolster their case for reimbursement requests (coupled with Ph IV data) across those EU countries yet to come on board which is why there is delay with France Denmark etc. But it makes sense that, given the new new performance rights plan with a focus on high growth and a target of $7.5 billion MC, they could be throttling growth down to later ramp up growth to achieve this goal within the 3-4 year timeframe (though reimbursement negotiations in Europe do take their time).

Either ways, both reasons will have a positive effect.
  Forum: By Share Code

macgyver
Posted on: Oct 23 2019, 09:33 AM


Group: Member
Posts: 681

Who else has a framed Epitan Share Certificate on their wall? Pride of place no doubt rolleyes.gif
  Forum: By Share Code

macgyver
Posted on: Oct 22 2019, 02:52 PM


Group: Member
Posts: 681

Clinuvel the next CSL. Current sp views Clinuvel as the next Sigma Pharma. CSL is a juggernaut at the moment, ploughing through $250 a share. Come on CUV🤬🤬🤯🤯
  Forum: By Share Code

macgyver
Posted on: Oct 22 2019, 08:51 AM


Group: Member
Posts: 681

This is a very interesting post. I have long suspected (my favourite conspiracy theory) that share price suppression has favoured Clinuvel management, especially when performance rights have vested previously at a artificially lowered price (shorted price). Of course it would be tantamount to illegal behaviour, but whose not to say that it couldn't happen through proxies or any other mechanism. The sp movements over the last 5 years have occurred after periodically sustained sp pauses, only to suddenly rise to unexplainable heights where shorters or others were suddenly wished out of existence.

Sure, sp movements coincide with expectations and impending deadlines, but given the relatively low liquidity of this stock, such activity would be easy to execute. I figure if shorting is legal, then perhaps this kind of manipulation is also kosher with ASIC.
  Forum: By Share Code

macgyver
Posted on: Oct 21 2019, 04:01 PM


Group: Member
Posts: 681

Nearly green Billy, let’s hope the shorts are scraping the bottom of the barrel😉
  Forum: By Share Code

macgyver
Posted on: Oct 21 2019, 09:42 AM


Group: Member
Posts: 681

Shortman showing decrease in shorts by another 0.25 percentage points down from 5.58% last week. I think this might be a blip of sorts as the daily percentage of volume as shorts is on the rise.
  Forum: By Share Code

macgyver
Posted on: Oct 19 2019, 01:37 PM


Group: Member
Posts: 681

Going over the performance rights for PW and Co, I found some of these to be a bit soft, as in they are going to issue imminently regardless of outside events . It would take a catastrophic event for some of these not to be issued. But probably for the first time, It’s now a strongly incentivised target to the company to increase shareholder return to the tune of $7.5 billion market cap. This has an air of confidence about it, and it’s pleasing to see a focus on accelerating the growth and ROI from the company. They will have done the sums, and I wonder if this too will be imminently issued in short order rather than over a four year period. Time to ramp up🔥
  Forum: By Share Code

macgyver
Posted on: Oct 18 2019, 09:50 AM


Group: Member
Posts: 681

To my mind I think profit taking has already occurred, probably the bulk of it not more than 2-4 days after approval if that. Anyone selling out now for a meagre profit at these prices would have rocks in their heads (day traders only survive on cereal and coffee anyway). The shorting pattern is clear (downward increments of $1 or more). I think it’s high time to jump on the NASDAQ and have more players in the pool to offset the influence of these individuals. They obviously know news comes slowly for Clinuvel (though they were caught with their pants down on approval day) and take advantage of it. I’m expecting a drop to $30 and then see what happens..
  Forum: By Share Code

macgyver
Posted on: Oct 18 2019, 07:48 AM


Group: Member
Posts: 681

As a distribution strategy vitiligo is ideal to pursue as the next indication as more treatment centres/affiliated hospitals etc will be needed. The number of vitiligo patients wanting treatment will most likely be staggering and the onus is on Clinuvel to ensure plans are in place to expedite delivery and reach theses patients across the country. They simply cannot dawdle and have consistent bottlenecks. Widespread distribution will see Scenesse harder to control and I suspect Clinuvel will eventually succumb to reality and let doctors anywhere have access to the drug. The FDA would have to agree with this surely (their viewpoint probably legally irrelevant by this time). With that in place, and the implant likely to cost less than current pricing, off label use for HHD will be much more affordable and the uptake by these off label patients will be such that revenues will be propelled to new heights in short order.

Don’t be surprised if this happens, and do expect the number of off label patients to eventually outnumber indication patients. Personally I think it will be folly for Clinuvel to control distribution, there is nothing either noble or ethical about withholding access to a versatile drug as Scenesse.
  Forum: By Share Code

macgyver
Posted on: Oct 17 2019, 07:40 PM


Group: Member
Posts: 681

I’m glad you said “within months” and not “in the coming weeks”, that would’ve been depressing🤣
  Forum: By Share Code

macgyver
Posted on: Oct 17 2019, 07:37 PM


Group: Member
Posts: 681

Shoot up every 4 hours?!? Say whaaaattt?!?! 🤣🤣🤣
  Forum: By Share Code

macgyver
Posted on: Oct 17 2019, 02:18 PM


Group: Member
Posts: 681

Approval for vitiligo is possible within two years, Hailey Haliey Disease not long after given Clinuvel had a trial for that already with very good results.

https://www.ascopost.com/issues/december-25...ug-indications/
  Forum: By Share Code

macgyver
Posted on: Oct 16 2019, 07:48 AM


Group: Member
Posts: 681

Just need Ross Greenwood and ol' mate David Koch on board and we'll have saturation of the mainstream Australian business media. biggrin.gif
  Forum: By Share Code

macgyver
Posted on: Oct 15 2019, 06:34 PM


Group: Member
Posts: 681

Your explanation of the circumstances is completely logical and for the most part I agree with it. However, this company’s sp has been easily manipulated from the early days and I don’t see that changing much until, as Verhaven put it, the pudding runs out. When is that? Not for a while yet. Solid revenues is perhaps the only thing which will negate shorting influence and that will take some time to occur. If it happens within 18 months, I’d consider it good fortune and hopefully results in a squeeze with the sp having met its inflection point if not already.

Pleased to see Desiree Lyons recognised in the letter from the Chair.

When is Tom Petrosky going to have a shave? The Ernest Hemingway of Commsec🤣
  Forum: By Share Code

macgyver
Posted on: Oct 15 2019, 09:41 AM


Group: Member
Posts: 681

It’s about price discovery apparently. We’ll be discovering lower prices I’m sure 🤣🤣
  Forum: By Share Code

macgyver
Posted on: Oct 14 2019, 02:15 PM


Group: Member
Posts: 681

I don’t think it will head back sub $30 (I’m hoping anyway). The volume over the last 4-5 trading has been substantial and the shorts only counted for a relative small percentage overall. Substantial interest in the stock has occurred and it will be on many more analysts’ radars so I hope there will be smarter, consistent buying that keeps the shorts in check.

Price looks to be settling down a bit. If shorts keep going from here they will be adding to a very large open position as it is. I’m not sure they are that game now that FDA approval is in hand to wantonly bet against the stock come what may. And with imminent announcements forthcoming which could jolt the sp in the right direction, if they’re not careful they might require some Avita medical attention🔥🥵
  Forum: By Share Code

macgyver
Posted on: Oct 14 2019, 06:56 AM


Group: Member
Posts: 681

This is a marked change from previous timelines. “ In the coming weeks” referred to a year or more. “ In the next few weeks “ could mean months only....
  Forum: By Share Code

macgyver
Posted on: Oct 14 2019, 01:40 AM


Group: Member
Posts: 681

Nice find. Stealth blockbuster?😉
  Forum: By Share Code

macgyver
Posted on: Oct 13 2019, 08:43 PM


Group: Member
Posts: 681

Thats the trick my friend, to be mentally free of this stock. Looking forward to the day I sell out, there are other things to life than sweating about the sp. But I'm growing impatient, and dreaming makes it worse!
  Forum: By Share Code

macgyver
Posted on: Oct 13 2019, 09:56 AM


Group: Member
Posts: 681

I have been seriously underestimating the value of the EPP market of late and I'd thought I would have a look at the sums again.

Can someone correct me on this:

327 million pop in the United States. EPP frequency of occurrence 1:75000 = 4360. (I'm not sure if ethnicity plays a factor here as with variegate porphyria).

Conservative uptake I'd put at 1500 (that's completely realistic given we are at nearly 600 patients in Europe even too low).

1500 X ($22,000AUD X 4) = $132 million/ 49 million shares (approx) = $2.69 per share X P/E 20 = $53.87

UK: 880 patients potentially (66 million/75,000). 200 patients (extremely conservative given NICE obsfucation and other dilemmas)

200 X ($22,000x 4) = $17.6 million/ 49 million shares (approx) = 35 cents per share X P/E 20 = $7

Total conservative total = Approx $61 a share.

Add $27 to the US total for an extra two implants ( 6 per annum for US patients) and it evens out at approx $88. This seems far too easy on paper, am I missing threats and barriers here?

Edit: 70% profit margin = $150 million = $61.60 per share.
  Forum: By Share Code

macgyver
Posted on: Oct 13 2019, 09:41 AM


Group: Member
Posts: 681

90% of all securities required for a compulsory acquisition.

https://www.minterellison.com/articles/summ...n-takeover-laws

PW and Biljdorp's holdings combined is over 10%, the first barrier to a takeover, hostile or otherwise. Whoever comes knocking will have to reach deep into their pocket wub.gif

  Forum: By Share Code

macgyver
Posted on: Oct 11 2019, 07:27 PM


Group: Member
Posts: 681

Given the trials and tribulations of the rollout in Europe and the lessons learnt, coupled with national reimbursement and nationwide distribution entities who specialises in storage distribution and delivery in the US, I figure delivery within 12 months is very achieveable. Hospitals already selected, not sure if all agreements are in place. But as far as training goes, it won’t be that hard to administer the drug. Hell, I’m pretty sure I could do it.

Dr Wally, you game??
  Forum: By Share Code

macgyver
Posted on: Oct 11 2019, 03:37 PM


Group: Member
Posts: 681

I’d rather see the dry powder go towards R&D/trials etc than worry about expansion through aquisition. I agree with Klomp, enhanced distribution for OTC/cosmeceuticals seems a natural fit for Clinuvel’s wider market aspirations unless there is a business with compelling IP to compliment Clinuvel’s strategy (can’t think of anything being complimentary to afamelanotide other than Clinuvel’s own unreleased molecules).
  Forum: By Share Code

macgyver
Posted on: Oct 11 2019, 08:38 AM


Group: Member
Posts: 681

Speak for yourself🤣
  Forum: By Share Code

macgyver
Posted on: Oct 11 2019, 08:17 AM


Group: Member
Posts: 681

I noticed PW and Keamy mentioned about conservative R&D spending to control costs while expanding the group to add value. I think from this point on taking on some debt to fund activities would be easy, cheap, and pay for itself in short order. PW is looking older these days...
  Forum: By Share Code

macgyver
Posted on: Oct 11 2019, 08:05 AM


Group: Member
Posts: 681

$800-1600 a share?👀 Now you’re just teasing....

Clvly and UR9 held up relatively well overnight compared with CUV yesterday.
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 10:51 AM


Group: Member
Posts: 681

Some heat dissipating from the trading slightly, still an impressive 1m plus shares traded in first two hours. Maybe it'll kick up a gear in afternoon trading...
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 09:35 AM


Group: Member
Posts: 681

I hope they open a treatment centre in Beverly Hills devilsmiley.gif
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 09:20 AM


Group: Member
Posts: 681

Do we have Seattle and Boston in there as well? A couple of pins towards the south I'm not familiar with their location..
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 09:13 AM


Group: Member
Posts: 681

The shorts or whoever is doing their damndest to suppress the price, throwing multiple sell orders into the path of the buyer but the buyer has a bulldozer!
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 08:45 AM


Group: Member
Posts: 681

Time for some super sleuthing, which cities and which hospitals?👁

Attached Image

  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 08:16 AM


Group: Member
Posts: 681

Ahh I see. Ok yeah that clears it up for me. Cheers graduated.gif
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 08:15 AM


Group: Member
Posts: 681

I'm not familiar with the U.S reimbursement process, I can only compare the process with what's happened in Europe. The U.S market and affiliates being much wealthier wouldn't think twice or balk at the cost of Scenesse when compared with other exorbitantly priced drugs in the States I would imagine.

So in effect, rollout should be expedited. Expert centres identified already, get drug to market, patients deal with their respective insurance companies, no need to wrangle with a national authority a la NICE.

This seems too straight forward compared to Europe. Am I missing something here?
  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 08:04 AM


Group: Member
Posts: 681

I didn't quite get the gist of PW's response to the question about reimbursement in the U.S.

I believe he said that currently there are U.S. patients travelling to Europe for treatment who are being reimbursed by their respective health insurance companies, and that this seemed to be working. I didn't really understand that response. For me it would be a two-fold answer: negotiate with national authorities for a uniform price, and/or health insurance companies agree to pay price based on the level of insurance patients opted to pay.

Is he suggesting he is satisfied with health insurance companies stepping in in the absence of a negotiated, subsidised pricing regime from the government?

  Forum: By Share Code

macgyver
Posted on: Oct 10 2019, 02:19 AM


Group: Member
Posts: 681

I’m expecting another day of positive action though probably not quite as furious as the last 24 hours. I’m sure a squeeze occurred yesterday, perhaps a combination of new investors and shorts covering, there is no other obvious explanation for such large buying right up till the closing bell.

I also think a mistake in the data has occurred again on Shortman.com, I figure at least 2-3% more still to cover today.
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 04:13 PM


Group: Member
Posts: 681

VP still at concept stage. Vitiligo progression sounds more promising with FDA discussions to follow concerning clinical program.

VP still up in the air. I'm betting this may change to another indication. I put forward a question about off label use, it got thrown in the bin. After today's rally, I forgive you PW.
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 03:24 PM


Group: Member
Posts: 681

Apologies in advance. I feel like swearing for some reason.

FUCK, WHAT A DAY!!!!🥂🍻🍆💦🤪🤣🤣🥳🥳🥳

Good on you NewToCli, well deserved payoff for you. Enjoy🥳
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 01:30 PM


Group: Member
Posts: 681

Exactly. Is a squeeze now in effect?
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 01:20 PM


Group: Member
Posts: 681

Bro, whoever is buying has some staying power indeed. If we get to $45 the decks are cleared for a quick run🤪🤪🤪

10k@$42.50 gobbled up.
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 10:10 AM


Group: Member
Posts: 681

Maybe a combination of both. Now that the big guns have settled into their algorithms they could certainly keep shorting, perhaps from the high of $42.38 even. But 500k volume in 1 hour is highly unusual, we'll see tomorrow on shortman.com...
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 09:57 AM


Group: Member
Posts: 681

Been sitting in front of the computer for a while this morning and it feels like the trading has been going a few hours. Just checked the time and its only been 56 minutes since the market opened. Volume closing in on 500k. Shorts are covering quickly.
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 09:15 AM


Group: Member
Posts: 681

🍆💦💦🤪
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 09:14 AM


Group: Member
Posts: 681

Ohh yeah baby....
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 09:08 AM


Group: Member
Posts: 681

Holy FUCK!
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 08:55 AM


Group: Member
Posts: 681

Market is shaping up nicely. $33.71 indicative open. Low volume but that will change considerably I think.

$40 close possible today? Nah, get out of here...

Edit: $39.50 and climbing... I'm changing this by the minute biggrin.gif
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 07:39 AM


Group: Member
Posts: 681

Attached Image

  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 05:22 AM


Group: Member
Posts: 681

Interesting scenario of which I'm very curious about. Its a question of ethics versus profitability for PW. He's been adamant about Scenesse being used specifically for medicinal purposes, whether that was to appease the FDA or a genuine deep seated belief in administering Scenesse according to an ethically rigorous regime I'm not sure.. However, if the FDA has granted approval without conditions then hopefully PW can remain mute on the subject without contradicting his stance and let the future take its course.

There is nothing unethical about off label for medicinal purposes, indeed as I've mentioned before it would be unethical to withhold treatment for an extended period from patients suffering other afflictions if Scenesse is available now.

Off Label use for psoriasis, Hailey-Hailey Disease and other afflictions would put a rocket under the sp as long as reimbursement is given. Today is the tipping point, tomorrow we'll see...

By the way I'm tipping the trading halt to cease between 11:30am and 1:30 pm AEST. one word for the shorts: FIRE!!!
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 04:11 AM


Group: Member
Posts: 681

biggrin.gif
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 03:32 AM


Group: Member
Posts: 681

Can we mention off label now? devilsmiley.gif
  Forum: By Share Code

macgyver
Posted on: Oct 9 2019, 03:32 AM


Group: Member
Posts: 681

Absolutely not!

Congrats everyone, just woke up and saw the good news. Currently numb at the moment. Will sink in when the sp moves north. Relief comes to US EPP sufferers. biggrin.gif
  Forum: By Share Code

macgyver
Posted on: Oct 8 2019, 04:30 PM


Group: Member
Posts: 681

The approval and short squeeze (if any) will make things interesting over the coming days. I agree with the bottlenecks analogy, it’s hard to see punters buying up large just yet. PW surely must change tack and release the Kraken so to speak concerning PRs about everything that has been promised this far but is undercover till the FDA sign off.

There is simply no other reason to remain secretive except for competition, though there is no competitive disadvantage in moving forward with plans already known to the public. Expecting the Australian and Japan applications to be submitted simultaneously😉
  Forum: By Share Code

macgyver
Posted on: Oct 7 2019, 07:38 PM


Group: Member
Posts: 681

I think paying 100k Euros for the first 250k Euros of sales for OTC and cosmeceuticals is a bit out there. And great point about vitiligo: wtf is happening with that?

  Forum: By Share Code

macgyver
Posted on: Oct 7 2019, 01:06 PM


Group: Member
Posts: 681

Very purple..
  Forum: By Share Code

macgyver
Posted on: Oct 7 2019, 12:17 PM


Group: Member
Posts: 681

Does anyone know what the sp has to get to to buy a football team?
  Forum: By Share Code

macgyver
Posted on: Oct 7 2019, 10:24 AM


Group: Member
Posts: 681

Tax haven.
  Forum: By Share Code

macgyver
Posted on: Oct 7 2019, 10:23 AM


Group: Member
Posts: 681

Agreed. Didn’t see anything in there about FDA approval incentives. Better to give us the bad news regarding excessive incentive payments before the good news on Wednesday. Loyalty payments wtf?? They must be anticipating big revenues to cover this pork...
  Forum: By Share Code

macgyver
Posted on: Oct 7 2019, 04:20 AM


Group: Member
Posts: 681

I’m mega hyped as well. D-Day is nearly here, and the beginning of the rest of our lives. Counting chickens? Sorry, it’s hard not to get carried away🤷🏽‍♂️
  Forum: By Share Code

macgyver
Posted on: Oct 4 2019, 05:30 PM


Group: Member
Posts: 681

If approval comes through, my wife will be squeezing all week long🤣🤣🤣🍆💦
  Forum: By Share Code

macgyver
Posted on: Oct 4 2019, 02:49 PM


Group: Member
Posts: 681

Somebody’s squeezing today😉
  Forum: By Share Code

macgyver
Posted on: Oct 4 2019, 05:24 AM


Group: Member
Posts: 681

I remember distinctly Austria was mentioned in a very early PR as one of four countries receiving Scenesse, however 4 patients and an ombudsman is not what I expected.

Ahh, FDA approval can salve many wounds...
  Forum: By Share Code

macgyver
Posted on: Oct 3 2019, 05:01 AM


Group: Member
Posts: 681

May I suggest it is something innocuous as the FDA making a mistake issuing a PDUFA date that falls on a Sunday so they changed it to a Tuesday to allow two extra business days to cover the Saturday and Sunday which are non-business days?

This is extremely positive news, the FDA sees fit to clarify the PDUFA date close to the original date, reaffirming everything is on track for a decision to be made. If there were any extensions we would’ve heard about it by now. Yes, a CRL is still possible but I think we’re there.
  Forum: By Share Code

macgyver
Posted on: Oct 2 2019, 01:04 PM


Group: Member
Posts: 681

When will it ever end indeed...
  Forum: By Share Code

macgyver
Posted on: Oct 1 2019, 08:24 PM


Group: Member
Posts: 681

Eh? So it’s possible the FDA could delay without extending the clock kinda thing? It’s possible we could wait another 3 months?? All of this is doing my farkin head in🤪🤪🤪

I’ll be thankful for approval just to give me back my sanity🤷🏽‍♂️
  Forum: By Share Code

macgyver
Posted on: Sep 30 2019, 08:30 AM


Group: Member
Posts: 681

Amen to that. Madman, if you can read this, hold on to your million shares buddy!
  Forum: By Share Code

macgyver
Posted on: Sep 30 2019, 08:28 AM


Group: Member
Posts: 681

Good way to minimise capital gains tax at any rate. Not sure if we can do it in Australia but certainly worth looking into.

"If anybody in this country doesn't minimise their tax they want their head read. As a government I can tell you you're not spending it that well that we should be paying extra." Kerry Packer
  Forum: By Share Code

macgyver
Posted on: Sep 27 2019, 04:48 PM


Group: Member
Posts: 681

Unbelievable. We are about to enter into the final week, nearly five years after the EMA first granted conditional approval. It’s going down to the wire, and it’s starting to feel like it’s going to be an historic occasion. Much more goodwill, opportunity and fortune to come, but hopefully in much less time. I’m old!
  Forum: By Share Code

macgyver
Posted on: Sep 27 2019, 10:59 AM


Group: Member
Posts: 681

Looks the sp is headed to $60 plus on approval devilsmiley.gif
Attached Image

  Forum: By Share Code

macgyver
Posted on: Sep 23 2019, 02:27 PM


Group: Member
Posts: 681

I think your hatred for the FDA and the constant negativity in your posts concerning the FDA has probably influenced the shorters.
  Forum: By Share Code

macgyver
Posted on: Sep 21 2019, 06:21 PM


Group: Member
Posts: 681

Huge ABs fan, been watching them when I can since playing local rugby down here in Tasmania. A strange game before I started playing, but when I saw the ABs play I knew I was watching one of the greatest sporting teams the world has ever seen. Bula Fiji!
  Forum: By Share Code

macgyver
Posted on: Sep 21 2019, 01:54 PM


Group: Member
Posts: 681

No I don’t think I will. Hope everything is good on your end. Go the All Blacks.
  Forum: By Share Code

macgyver
Posted on: Sep 21 2019, 05:09 AM


Group: Member
Posts: 681

I agree with No.2. The large amount of shares shorted with an impending approval could be the aim of the game: a modest profit on a large volume.

I'm also hoping No.3 comes into play as well. That would be a nice Xmas gift:)
  Forum: By Share Code

macgyver
Posted on: Sep 19 2019, 05:47 PM


Group: Member
Posts: 681

You can thank the shorts for the volume and no one else. Don’t be surprised to see significant volume with little movement in the sp. it would be nice to see other punters jumping in and buying up to put the squeeze on but I think these guys are all over it.
  Forum: By Share Code

macgyver
Posted on: Sep 19 2019, 10:07 AM


Group: Member
Posts: 681

Who didn’t see this trade coming?..... 2 million shares will be covered in short order.
  Forum: By Share Code

macgyver
Posted on: Sep 13 2019, 05:08 AM


Group: Member
Posts: 681

Two quarters ago Clinuvel had increased expenses of over $1m (1.3 or 1.8m, I can’t recall exactly). I assumed it was in anticapation of July PDUFA for either rollout or drug stocks. Also a few years ago it was discussed on one of the forums about a company in America that specialises in drug logistics. A comprehensive one stop shop for storing, management, and secure delivery. Given the slow rollout in Europe, I’m hoping Clinuvel has everything in place for expedited delivery.

It should be noted too that Clinuvel has already identified preferred centres from which to administer the drug. Whether agreements are in place is another question.
  Forum: By Share Code

macgyver
Posted on: Sep 11 2019, 06:46 AM


Group: Member
Posts: 681

Exactly. Traders had/have a defined time limit before PDUFA, and barring big whales jumping in and buying up stock CUV shares are at their mercy. Listing on the NASDAQ would bring more traders into the pool, making it both volatile and lucrative for current shareholders.
  Forum: By Share Code

macgyver
Posted on: Sep 10 2019, 02:38 PM


Group: Member
Posts: 681

46k order?? Hope this bullshit is over soon👎
Attached Image

  Forum: By Share Code

macgyver
Posted on: Sep 8 2019, 09:49 AM


Group: Member
Posts: 681

I have Mickey Thompson AT3s on my Prado in Oz, less noise than muddies but plenty of tread. Solid as.
  Forum: By Share Code

macgyver
Posted on: Sep 7 2019, 09:23 AM


Group: Member
Posts: 681

Palatin didn't issue a PR for labelling of Vyleesi so I'm not expecting it here, though PW may issue one to salve our wounds.

  Forum: By Share Code

macgyver
Posted on: Sep 5 2019, 11:48 AM


Group: Member
Posts: 681

Yeah, I know what you mean. Believe me, I’m not even remotely thinking about FDA rejection. We have five weeks left of this bullshit as it is, if the FDA rejects we’ll be in for many more months of it....
  Forum: By Share Code

macgyver
Posted on: Sep 5 2019, 12:31 AM


Group: Member
Posts: 681

🤣🤝😉
  Forum: By Share Code

macgyver
Posted on: Sep 4 2019, 08:25 AM


Group: Member
Posts: 681

Straight to $41 today? Its high time.... tongue.gif
  Forum: By Share Code

macgyver
Posted on: Aug 31 2019, 05:23 PM


Group: Member
Posts: 681

Nektar Therapeutics about to be sued by Rosen Law Firm via a class action of shareholders for, among other things, not following GMP. Maybe Clinuvel needs a lawsuit to put a firecracker in PWs butt...

https://www.globenewswire.com/news-release/...utics-NKTR.html
  Forum: By Share Code

macgyver
Posted on: Aug 31 2019, 11:51 AM


Group: Member
Posts: 681

I didn’t see any labelling announcement from Palatin on their website only going back to Nov 2018 (they would’ve announced it in the time surely). Clinuvel may decide to announce it to ease consternation among investors but I doubt it.

Procedure wise, is there a timeframe for the FDA to convey labelling requirements e.g 1 month prior to PDUFA? I figure if we haven’t heard any news at all by the end of the next fortnight then that ship has passed and it’s down to doom or glory.
  Forum: By Share Code

macgyver
Posted on: Aug 29 2019, 11:23 PM


Group: Member
Posts: 681

You really have a hard-on for the FDA, and now it looks like NICE is in your crosshairs. Why isn’t PW in your crosshairs? At this point in time he’s probably just as guilty of fluffing further expansion of Clinuvel as the FDA is guilty of a supposed conspiracy against Clinuvel (total nonsense by the way).

The FDA rejected afamelanotide the first time around as a cosmetic, and rightfully so. It is Clinuvel who have dilly-dallied and only submitted the f-ing dossier last year. The FDA have granted orphan status and priority review to the goddamn drug. And you’re carping on about the FDA having a problem with Clinuvel?? Don’t you think for once that the problem might be elsewhere??

You seem to think that the burden of responsibility rests on those organisations for the delay in getting Scenesse to market. That might have been the case with the EMA, but it’s getting harder to blame them when the CEO doesn’t even follow through on his own timelines and announcements.
  Forum: By Share Code

macgyver
Posted on: Aug 29 2019, 12:20 PM


Group: Member
Posts: 681

I was pleased with the financial results. Revenue still increasing and no signs of revenue plateau in Europe so far. However, PW and Co seem to be very astute when it comes to engineering generous remuneration packages. It seems every year we’re seeing more lucrative incentives offered by Clinuvel but it doesnt seem commensurate with the slow progress of FDA approval and all the other developments that are supposed to be in full swing.

Vitiligo results came very late, OTC products chucked in the bottom drawer till after FDA approval (which admittedly for the first time yesterday I spotted a reference to ‘suncare’), no trials of any kind having commenced in Europe or anywhere else etc etc. $50 million in the bank is prudent management but I don’t think it’s smart to leave it sitting there. Its handicapping the company from advancing its product development. Why is everything conducted in 5 year intervals FFS?
  Forum: By Share Code

macgyver
Posted on: Aug 28 2019, 12:49 PM


Group: Member
Posts: 681

I'm pleased with the result but most impressive for me from this report was the 8% increase in expenses. This is good maintenance, especially given that Clinuvel has put aside a substantial amount of money to fund US rollout.

No word on other EU countries joining, there's a blackout which I find concerning. It's not a problem as long as revenue and profits increase yoy, and it wont matter much or will be forgotten once US revenue starts coming in. But still, if EU revenue plateaus over next 2 years we know what the problem is.

$50+million war chest. Come on Vitiligo trials!!

Willem Bijdorp is Rocket Man without hair..
  Forum: By Share Code

macgyver
Posted on: Aug 27 2019, 06:32 AM


Group: Member
Posts: 681

For some reason I was more excited when we were at $39. Now with trade wars and FDA delays I think the wind has been knocked out of the sails a bit. Approval will come as a sigh of relief rather than sheer ecstasy, though I’ll still be cracking open a Penfolds Grange to celebrate🥂
  Forum: By Share Code

macgyver
Posted on: Aug 26 2019, 10:38 AM


Group: Member
Posts: 681

You are an ungrateful person, especially considering we have to put up with your inane posts.

In other news, no announcement about the AdCom thus far. I’m giving it another day just to be safe, then I’ll consider it home and hosed (or at least it’s down to just CRL or glory).
  Forum: By Share Code

macgyver
Posted on: Aug 25 2019, 11:12 AM


Group: Member
Posts: 681

I'm assuming if we don't see an announcement from CUV come Monday or Tuesday then we're in the clear regards the AdCom.
  Forum: By Share Code

macgyver
Posted on: Aug 20 2019, 09:23 PM


Group: Member
Posts: 681

Judging by the relatively large sell orders appearing out of nowhere today which were snapped up in due haste, I don’t think these guys are worried. Of course it’s good to see them buying on the market but this is far too robotic to be coincidental. My investment is at the mercy of professionals’ whims. Such is life...
  Forum: By Share Code

macgyver
Posted on: Aug 20 2019, 10:52 AM


Group: Member
Posts: 681

QUOTE
Vague as this may sound


Pierre, if one word can describe the last 20 newsletters, it would be “vague”.
  Forum: By Share Code

macgyver
Posted on: Aug 19 2019, 04:53 PM


Group: Member
Posts: 681

That’s rather striking, with the number of open shorts likely being reduced after today’s trading the shorts are wisely winding up their efforts (I hope). If this continues is it reasonable to expect positive upswing next week or so?
  Forum: By Share Code

macgyver
Posted on: Aug 18 2019, 08:08 PM


Group: Member
Posts: 681

I asked Johnny H recently the same question. He can tell you, it’s a possibility afaik.
  Forum: By Share Code

macgyver
Posted on: Aug 13 2019, 07:27 AM


Group: Member
Posts: 681

Please correct me if I’m wrong, has this particular trial been completed 2009? Is this just uploading results from this phase 3 trial to a govt registry of sorts?


Edit: just read your post. All good. Hope this doesn’t add on time to the NDA.
  Forum: By Share Code

macgyver
Posted on: Aug 6 2019, 08:31 AM


Group: Member
Posts: 681

It will be interesting to see whether they do market directly to patients in the US. They don’t do it in Europe, preferring to let patients and support groups spread the word rather than actively market the drug. Not sure why that is, perhaps this is another example of staying under the radar until FDA approval is in the bag.

I certainly see no reason for Clinuvel not to market the hell out of Scenesse. It wouldn’t make sense to market their cosmeceuticals alone when Scenesse is the main breadwinner.

  Forum: By Share Code

macgyver
Posted on: Aug 5 2019, 02:25 PM


Group: Member
Posts: 681

Sell side fake??

Attached Image

  Forum: By Share Code

macgyver
Posted on: Aug 5 2019, 02:16 PM


Group: Member
Posts: 681

So going by the 35-45 day calendar, we have perhaps less than 3 weeks of tomfoolery before the sp rise. Or less if shorters look to start buying back for fear of supply tightening up. Hang on for dear life⛵️
  Forum: By Share Code

macgyver
Posted on: Aug 5 2019, 01:43 PM


Group: Member
Posts: 681

Because they are the institutions, with disciples fingering Bloomberg terminals and access to info I'm assuming you don't have. This stock has always been controlled, going right back to 2014. I remember with derision in 2014 when the stock volume was about 40k shares traded per day. Very robotic no? I think its more than a coincidence. In this case, when the stock went to $39 the shorters had no idea they would be a delay. They now know that Oct 6th will not be another delay but an actual decision made. Knowing this and with 9 weeks approx left, why not take the gamble and drive the sp down? They know how much time they have, which is more than what they knew pre-delay.
  Forum: By Share Code

macgyver
Posted on: Aug 5 2019, 01:33 PM


Group: Member
Posts: 681

I think its the last shakeout and gamble to short, which will be over very shortly I'm guessing. Bold and ballsy, we are insignificant...

Thank you for not ramming safety and efficacy down our throats today. Loving the slight detour into the nether regions of your mind...
  Forum: By Share Code

macgyver
Posted on: Aug 5 2019, 10:15 AM


Group: Member
Posts: 681

It appears the shorters have ramped up their efforts, I'm assuming because they know approval is imminent this time around and the price will invariably rise back to higher levels if not $40 minimum. The percentage of shares shorted is averaging higher than its ever been IMO. Someone is making and going to make a nice profit each way. (Apologies for the messy cut and paste, its not submitting as clean as it should).

Thu 1st Aug, 2019 60,808 48,960,633 0.12% 194,659 31.24%
Wed 31st Jul, 2019 31,858 48,960,633 0.06% 172,449 18.47%
Tue 30th Jul, 2019 29,705 48,960,633 0.06% 245,740 12.09%
Mon 29th Jul, 2019 81,648 48,960,633 0.16% 168,236 48.53%
Fri 26th Jul, 2019 126,931 48,960,633 0.25% 395,113 32.13%
Thu 25th Jul, 2019 108,597 48,960,633 0.22% 247,497 43.88%
Wed 24th Jul, 2019 82,190 48,960,633 0.16% 195,306 42.08%
Tue 23rd Jul, 2019 125,206 48,960,633 0.25% 247,876 50.51%
Mon 22nd Jul, 76,285 48,960,633 0.15% 256,141 29.78%
Fri 19th Jul, 2019 96,392 48,960,633 0.19% 273,678 35.22%
Thu 18th Jul, 2019 131,813 48,960,633 0.26% 251,696 52.37%
Wed 17th Jul, 2019 124,834 48,960,633 0.25% 287,585 43.41%
Tue 16th Jul, 2019 196,343 48,960,633 0.40%
Mon 15th Jul, 2019 162,765 48,960,633 0.33% 303,409 53.65%
Fri 12th Jul, 2019 63,813 48,960,633 0.13% 255,565 24.97%
Thu 11th Jul, 2019 62,102 48,960,633 0.12% 199,748 31.09%
Wed 10th Jul, 2019 56,622 48,960,633 0.11% 191,260 29.60%
Tue 9th Jul, 2019 32,700 48,960,633 0.06% 147,704 22.14%
Mon 8th Jul, 2019 103,107 48,960,633 0.21% 208,432 49.47%
  Forum: By Share Code

macgyver
Posted on: Aug 4 2019, 01:27 AM


Group: Member
Posts: 681

Increased dosage per annum? I didn’t know that more than 4 implants had been approved yet. If so, that’s great!
  Forum: By Share Code

macgyver
Posted on: Aug 1 2019, 07:37 PM


Group: Member
Posts: 681

The second stage of the journey? Will that entail posting about safety and efficacy still or can we look forward to an expansion of your analysis? I’m not hopeful; we still have the TGA in Australia and the Japanese drug authority who deserve your evil eye as well. They have no idea what’s coming...
  Forum: By Share Code

macgyver
Posted on: Aug 1 2019, 09:08 AM


Group: Member
Posts: 681

From my experience with QA procedures, everything should documented so it can be both verified and validated immediately or at a later date. A paper trail for everything, no matter how innocuous or seemingly irrelevant it might seem. This is pretty basic stuff that Evonik should have taken care of from the outset, though in saying that it is all part of the refining of the QA system to patch up discrepancies, especially in a new manufacturing facility.
  Forum: By Share Code

macgyver
Posted on: Aug 1 2019, 07:23 AM


Group: Member
Posts: 681

I like to see an early approval put the shorters on the back foot scrambling to buy up devilsmiley.gif
  Forum: By Share Code

macgyver
Posted on: Aug 1 2019, 06:15 AM


Group: Member
Posts: 681

Your lightbulb avatar is looking a bit dimmer today Johnnytech. Don’t worry, we’re both in the outhouse after my monumental stuff up last week concerning the unlimited validity/exceptional circumstances authorisation fiasco. I’m not lonely anymore!

Thanks Johhny H, is it possible we could see an earlier approval date? Or will the FDA ride this out till Oct 6th?
  Forum: By Share Code

macgyver
Posted on: Jul 31 2019, 09:53 AM


Group: Member
Posts: 681

Cash balance @ 30th June 2018: $36.198 million, and @ 30th June 2019: $54.269 million. By any measure that's impressive.


Good to see increasing number of patients coming in for treatment. I'd like some more info regarding where these patients are coming from, whether they are in Germany or if a new country has come online.

If Germany isn't maxed out and Clinuvel is adding countries at a rate of 1-2 year (I think Clinuvel is keeping mum about new countries for now), then the increasing revenues demands a higher appreciation from the market sp wise. A great year.
  Forum: By Share Code

macgyver
Posted on: Jul 30 2019, 03:10 PM


Group: Member
Posts: 681

Giles, Giles, Giles...

Can you tell us how your article about Silicon Valley is related to Clinuvel? I started to read it but, unsurprisingly, I failed to finish it. Is Clinuvel going NASDAQ shortly??
  Forum: By Share Code

macgyver
Posted on: Jul 28 2019, 09:38 AM


Group: Member
Posts: 681

Good luck trying to pronounce Tsumoyle...

I turned on the subtitles for this video. The accuracy of this mechanism has some way to go, at one point it translates a word as 'foreskin'. Maybe this is referring to the outer layer of the epidermis. At any rate, I would have thought that no matter how much Scenesse is applied, foreskin will remain forever wrinkly...
  Forum: By Share Code

macgyver
Posted on: Jul 26 2019, 12:56 PM


Group: Member
Posts: 681

TSU is a kana, a japanese syllabic script seen in examples like Tsukiji Fish Market in Tokyo. The Japanese would pronounce Tsumoyle as "Smoil", a Japanese interpretation of "smile' perhaps? I don't think its pronounced soomoil or sumoyle, but nonetheless it doesn't have a catchy ring from a marketing point of view. As an aside, a product that will have a tendency to tan skin seems counter to prevailing beauty trends in Asia with a preference for whitening skin.

Is it possible to reformulate afamelanotide to have the same benefits without the tanning aspect? It makes me wonder about the name since afamelanotide products would be better marketed to Western customers (I would think).
  Forum: By Share Code

macgyver
Posted on: Jul 26 2019, 11:11 AM


Group: Member
Posts: 681

I hope Mr Blijdorp, with his considerable experience in product commercialisation, can convince PW of the pressing need to change the name “Tsumoyle” to something else more pronounceable.
  Forum: By Share Code

macgyver
Posted on: Jul 24 2019, 11:47 AM


Group: Member
Posts: 681

This pretty much puts the question of whether PASS is still in play or not to bed. Scenesse still authorised under exceptional circumstances (updated 26/04/19), therefore just the renewal with unlimited validity to come.

Sorry peeps sad.gif

Attached Image

  Forum: By Share Code

macgyver
Posted on: Jul 24 2019, 09:22 AM


Group: Member
Posts: 681

Johnny H was on the right track regarding the possibility of up to 10 years or more post-authorisation monitoring. The screenshot below shows the drug Atryn having received positive opinions for both the annual reassessment and the 5 year renewal with unlimited validity. Atryn has had marketing authorisation under exceptional circumstances for 10 years having first been rejected early 2006 after which it was subsequently approved. That’s not to say PW isn’t pushing for a standard MA, but my expectations are tempered somewhat.

Curiously, Atryn has been withdrawn from the European market by the owner.

Attached Image

  Forum: By Share Code

macgyver
Posted on: Jul 24 2019, 07:27 AM


Group: Member
Posts: 681

QUOTE
Exceptionally, the CHMP may consider that all specific obligations have been fulfilled and comprehensive data on the efficacy and safety of the product is available. In such cases the CHMP may recommend granting a Marketing Authorisation not subject to specific obligations


I’m hopeful.
  Forum: By Share Code

macgyver
Posted on: Jul 24 2019, 02:33 AM


Group: Member
Posts: 681

Yes, I did jump the gun on that one🙋‍♂️
  Forum: By Share Code

macgyver
Posted on: Jul 24 2019, 02:30 AM


Group: Member
Posts: 681

I can’t say for sure whether Scenesse would have the PASS protocol removed, but since PW was seeking to abolish it and Clinuvel has applied for unlimited validity then it’s reasonable to assume this represents movements towards that outcome.

When a market authorisation is due to expire, the renewal application is submitted at least 7-9 months prior to expiration date. In the annex B2.2.2 there is no mention of an EMA request for supplementary information which I view positively (After all, what more could the EMA ask for after 5 years of PASS?).

Since reading in EMA literature itself about MAs under exceptional circumstances not normally receiving a standard MA, perhaps through the rapporteur was Clinuvel able to ascertain that Scenesse was a suitable candidate for a standard MA. Whatever the case, this is where Clinuvel is at so it’s remarkable to say the least.
  Forum: By Share Code

macgyver
Posted on: Jul 23 2019, 09:58 PM


Group: Member
Posts: 681

Scenesse is no longer classed as having a marketing authorisation under exceptional circumstances, instead it has obtained standard market authorisation

By rights, Clinuvel should now be unencumbered of obligations concerning collection of data and monitoring of patients concerning the PASS protocol. I believe PW was pushing to drop PASS because of costs and burden on the company, but acknowledges the invaluable data collected having intrinsic value for the company especially concerning the FDA NDA.

I wonder if this allows Clinuvel to now push 6 doses a year for EPP patients?

The surprising thing was that market authorisation under exceptional circumstances normally doesn't receive an "upgrade" to a standard market authorisation. The data and patient feedback must be overwhelmingly positive, which bodes well for the FDA...
  Forum: By Share Code

macgyver
Posted on: Jul 22 2019, 08:42 PM


Group: Member
Posts: 681

edit
  Forum: By Share Code

macgyver
Posted on: Jul 22 2019, 08:58 AM


Group: Member
Posts: 681

$500??? Sweet nothings will get you everywhere wub.gif
  Forum: By Share Code

macgyver
Posted on: Jul 19 2019, 02:02 PM


Group: Member
Posts: 681

A large number of the sell side orders have been above at least $36 for 2-3 weeks, so it’s not indicative of a sell off. However, in the last few days the sell side has increased so some retail investors are possibly stepping out for the time being. With shorts increasing substantially over the past few days we know where this is going.

I find it inconceivable that a big player is selling off altogether, though nothing surprises me concerning Clinuvel...
  Forum: By Share Code

macgyver
Posted on: Jul 16 2019, 10:31 AM


Group: Member
Posts: 681

I think the average increase across the last four (possibly 3 quarters, it was a while ago I tried to do an average increase calc) was something like 63-65%. I’m expecting the same this time around, which will be very pleasing and point to increasing patient registrations.

Edit: That’s yoy, relative to its own quarter which was still in the average mentioned above.
  Forum: By Share Code

macgyver
Posted on: Jul 14 2019, 12:02 PM


Group: Member
Posts: 681

Two documents concerning legislated improved approval timeframes for TGA (Australian drug authority) and actual reported (TGA report 2018).

The TGA has a pathway to accept comparable overseas regulator dossiers (FDA Clinuvel dossier).

https://www.tga.gov.au/sites/default/files/...7-june-2018.pdf

https://camargopharma.com/resources/blog/ex...roval-australia

  Forum: By Share Code

macgyver
Posted on: Jul 12 2019, 02:34 PM


Group: Member
Posts: 681

Agreed, we had a good run there for a while. But now thumbdown.gif
  Forum: By Share Code

macgyver
Posted on: Jul 12 2019, 10:16 AM


Group: Member
Posts: 681

Looking at how quickly new indications may be approved for an existing drug. The time varies considerably with different classes of drugs. Duxipent (by Sanofi and Regeneron) was approved for four indications in quick succession (March 4th 2017 - June 26th 2019). However two of them were for moderate to severe dermatitis (for adults with adolescents being granted 2019).

I noted the surprising speed with which this drug was able to go from Phase 2 trials to approval, with multiple indications following shortly after. This could point to the power of big pharmaceutical companies such as Sanofi and Regeneron with the FDA. Makes you think about Clinuvel's journey to date and how long its taken.

I think Clinuvel still has a part to play with dermatitis treatment. If their topicals prove to be sustaining. these could be priced cheaper (in good time) than Duxipent, not affect the immune system, and not require injecting.

https://www.drugs.com/history/dupixent.html
  Forum: By Share Code

macgyver
Posted on: Jul 11 2019, 11:42 AM


Group: Member
Posts: 681

I take it PW was only referring to the European data and the protocol in place there as a reference point for the FDA to analyse data from patient usage history

He doesn't say that FDA will initiate a similar patient monitoring scheme, just that Clinuvel has reams of safety data in the European scheme that the FDA has access to which bolsters the dossier (and is taking the FDA a lot longer to assess based on sheer volume of information).

To clarify, I'm not getting the impression that Clinvuel will repeat in America what has been done in Europe regarding the PASS protocol. In fact, I see PW's reference to the labelling e.g "black box or black triangle" as contributing to control of the product somewhat, but not placing strict controls on it such as distribution and select centres for administration.
  Forum: By Share Code

macgyver
Posted on: Jul 10 2019, 08:46 AM


Group: Member
Posts: 681

Clinuvel website is back up. No changes were made as far as I know.
  Forum: By Share Code

macgyver
Posted on: Jul 9 2019, 08:31 AM


Group: Member
Posts: 681

Expect some stern dressing down from PW in the newsletter when he finds out an intrepid investor has gone directly to the FDA to find out what went wrong. This occurred a few years ago when someone had contacted NICE and/or UK patients seeking news about anything Clinuvel. The totally appropriate methods punters resort to seeking information that rightfully should be in the public domain. Too bad Pierre...
  Forum: By Share Code

4 Pages (Click to Jump) V   1 2 3 4 >

Cant find what you are looking for? Show all active topics from the last 3 months


New Posts  New Replies
No New Posts  No New Replies
Hot topic  Hot Topic (New)
No new  Hot Topic (No New)



TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING