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Farleap11
Posted on: Nov 9 2019, 09:39 PM


Group: Member
Posts: 116

Good summary Macgyver. As has been said many times, the input and variety of views found on this board is why we keep coming back for updates, you just never know what you might find. Your references to the contributors listed and the roles they have played represent what I think to be a reasonable summary of their recent and not so recent contributions. I am particularly intrigued by what has happened to Dr Wally; seems to have gone from being such a prolific contributor to one that has suddenly fallen from the face of the earth; or is your comment about absconding with profits based upon something I have missed?

When all said and done the majority of us have a common goal (now and again questions arise over the motives of some) and as in any similar situation(s) the best way to reinforce those bonds is over a drink. The AGM in Melbourne is just around the corner and could be a great opportunity for those able to attend to do just that !!!!
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Farleap11
Posted on: Nov 9 2019, 08:32 AM


Group: Member
Posts: 116

Give it a rest JT and save yourself some energy and time. We are we are - we have FDA approval and the roads can now open up.

I can see no point in trying to discredit management for actions it has taken to achieve what previous managements have failed to do on no less than three occasions. Sure they might not seem ideal or appropriate when looked at in hindsight; however, the focus throughout this hugely challenging exercise was to achieve the previously unattainable approval which was in the obvious best interests of Company shareholders. If you wish to argue / oppose the CEO's performance bonus' then by all means do so but lets be thankful for what has been achieved and put the past behind us - life is too short!!

Bring on the AGM so we can find out what might lie ahead.
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Farleap11
Posted on: Oct 24 2019, 08:26 PM


Group: Member
Posts: 116

Apologies to all (particularly IntiRaymi) for misleading you on the closing price. As you correctly point out Verharven, in my haste I incorrectly typed A$34.40 instead of A$30.40. My calculation of monies outlaid was based upon the correct rate of A$30.40 x 200,000 to arrive at the A$6.08m.

No doubt like all other contributors on this board, I wish that it had closed at A$34.40. No doubt we will get back to that level and beyond in the coming months. In the meantime and in closing let me simply say, bring on the AGM.
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Farleap11
Posted on: Oct 24 2019, 04:52 PM


Group: Member
Posts: 116

Interesting that the overall shares traded for the day was 460,488 kicked along in no small way by a single trade of 200,000 at A$34.40 fifty minutes after normal close time!! That equates to an outlay of A$6.08m!!
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Farleap11
Posted on: Oct 22 2019, 10:29 PM


Group: Member
Posts: 116

There is an interesting article on "Shorting" published by the Australian Newspaper in their electronic version at 7.05pm this evening which reads as follows: Presumably it will appear in tomorrows general edition.
It is a subscription version and I am not able to get it to work via a simple link.

Shorting sharpens market efficiency
JAMES KIRBY
7:05PM OCTOBER 22, 2019
Short attacks are rattling the ASX as debate rages on the procedures and ethics of trying to make money from falling stock prices. But here’s the thing: shorting sharpens market efficiency.
The dramatic trading suspension of $7bn software group WiseTech Global - twice in one week - tells us shorting is now here to stay.
At their very best, short attacks are a very welcome cleanser in the market. At the very least, they can sniff out weakness in operations. At their most effective, they
On a macro level, it can work for whole regions. The Hong Kong dollar’s “peg” with the US dollar has lasted through the current turmoil largely because it was seriously tested by George Soros in 1998.
On a company level, Macquarie Bank is a strong contender on world markets from the time it defended itself successfully from short attacks led by Jim Chanos in 2007.
In contrast, we will not miss many of the companies that have wilted in the face of short attacks of late.
If the opportunity arises
The debacles at Blue Sky and Quintis – though dreadful for retail investors involved – were useful to the wider market in “keeping the bastards honest”.
Many of the best local funds are now operating as long/short investments where they have the ability to invest in conventional fashion and to ‘short’ if the opportunity arises.
For example, Phil King, of the Regal Funds group, who just last week was inducted into the Australian Fund Managers Hall of Fame runs a number of such funds.
On the specific issue of WiseTech and its attack from the little known J Capital group: Whatever else software giant WiseTech may be, it is not another sandalwood spruiker or provincial private equity wannabe.
Watching industry veterans such as Adrian Di Marco of Technology One - who survived the dot.com crash - putting his professional reputation on the line in defence of Richard White and his team suggests this “short attack” is not going to be an easy win.
J Capital has knocked $1bn off the value of WiseTech before we really have a complete picture of their critique, which includes allegations of inflation revenue and accounting irregularities.
Di Marco said target companies should be given the right to defend themselves before going on a trial in the court of public opinion.
This is a fair suggestion. Investigative journalism works this way where the “target” is given the right to explain themselves before an investigation is published.
Short attacks are useful, they are even welcome, but there should be rules.
Until the hugely successful short attack by Glaucus on Quintis back in 2017 – most ASX-listed companies were insulated from the realities of short attacks by global hedge funds.
Now we are fully on the menu, the only surprise is that it took so long.
After all, the shorting business has been running on Wall Street since the early 20th Century when it was popularised by Jess Livermore who made a vast fortune only to end up bankrupt and dead by shotgun suicide in 1940 aged 63. But that’s another story…
JAMES KIRBY

WEALTH EDITOR
James Kirby, The Australian's Wealth Editor, is one of Australia's most experienced financial journalists. He is a former managing editor and co-founder of Business Spectator and Eureka Report and has previously... Read more
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Farleap11
Posted on: Oct 14 2019, 04:06 PM


Group: Member
Posts: 116

“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……….”

It is worth going back to the communique issued by the CUV Chair Stan McLiesh dated 24 April 2019 when he reflected on his experiences with CUV over the years since first joining the Epitan Board of Directors in 2002. He made reference to the, “…quite different strategy that had been followed to obtain US regulatory clearance for the molecule now known as afamelanotide.” However, the sections of his release that I think underscore Frogster’s observations referred to above, read as follows:

“It was only after the Board had voted in favour of the current CEO and Dr Agersborg as CSO in late 2005 that a meaningful medical application for the drug would be found and a rigorous strategy developed. The chief executive set out to radically change the management and Board, whereby CSO Dr Wright and CFO Mr Keamy became pivotal executive managers………………………………….
“It was the current CEO who came up with a detailed (but unconventional) plan to capitalise the business in a most efficient and anti-dilutive manner which would enable the Company to reach today’s valuation. His unflinching conviction and energy to defy all critics and non-believers was needed to overturn two previous decades of a company floundering and not taking advantage of its technology and intellectual property. ………………………. As it has evolved, the realisation of Dr Wolgen’s early vision for the Company long-term has been with enormous success. ………”


So yes, Frogster and to all other contributors to this site, I agree that we as shareholders, have a lot to be thankful for, not the least being the Board and management team’s preparedness to adopt and have the courage to see through on the CEO’s so called “unconventional” plan. As you rightly say, the company has achieved a tremendous milestone.
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Farleap11
Posted on: Oct 9 2019, 01:06 PM


Group: Member
Posts: 116

I will be coming over from Interstate on Tuesday 19 November for the AGM on 20 November and would be in a position to catch up for a pre AGM drink / dinner that evening. At this point it looks as though I will be otherwise committed after the AGM and therefore unable to attend anything later on that day.
Regardless of whether I can make it or not, I think some time around the AGM date for a catch up might be a good opportunity for many although my obvious preference is the Tuesday.
Any other thoughts / suggestions.
In the meantime I think a good solid celebratory drink or two is in order, even more so if the closing price today is around the A$40 mark!! I suspect some of the less seasoned campaigners here that started early celebrations this morning might have a bit of trouble staying the distance to close.
Best of Aussie luck to all contributors to this board; as others have said already, it has been a marvellous source of information, comfort and frustration from some along this long and now well worthwhile journey.
  Forum: By Share Code

Farleap11
Posted on: Oct 4 2019, 12:13 AM


Group: Member
Posts: 116

First purchase (then under Epitan) was on 22 November 2001 - 19,633 @ A$0.1528 for A$3,000!! This was of course prior to the 10:1 consolidation that occurred nine years later on 18 November 2010!

It really has been a long and winding road since then with lots of buys and sells along the way; AND as much as I try to convince myself that it is not really happening, I too am not getting any younger.

I prefer to be positive and expect the wait to be worth it - roll on Tuesday into Wednesday. Not sure I will get much sleep that night.

GLTA
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Farleap11
Posted on: Sep 27 2019, 03:56 PM


Group: Member
Posts: 116

Help me out here AJS, how have you arrived at the 934,041 = 1.82%?
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Farleap11
Posted on: Sep 13 2019, 09:16 PM


Group: Member
Posts: 116

Very well said Epidan _ from a fellow shareholder who has been involved since Epitan day’s. These are testing times; however we have been here so many times before.
Let’s hang in there and maintain our confidence in the management judgement that has got us to where we are today.
I have resolved to block out negativity and maintain the faith Having come this far notwithstanding all the ups and downs. Been there before and still
Alive and kicking graduated.gif
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Farleap11
Posted on: Aug 23 2019, 09:24 AM


Group: Member
Posts: 116

You have a few mates / supporters. I bought in at 05 cents and sold a third at 15 cents to recoup my original outlay👍 Freewheeling for me from here!

Happy to bide my time now and just enjoy the ride
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Farleap11
Posted on: Aug 20 2019, 11:05 PM


Group: Member
Posts: 116

A couple more Mutual and Institutional Funds have been added to the major holders list as from 31 July 2019.

https://www.barrons.com/quote/stock/au/xasx/cuv
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Farleap11
Posted on: Aug 19 2019, 09:07 PM


Group: Member
Posts: 116

This does ring a bell for me thanks johnnytech. We have so much (mostly useful) information posted on this board it hard at times to keep track of it all.

The statistics you have provided do add to the growing list of reasons we should maintain confidence our long wait will be rewarded.
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Farleap11
Posted on: Aug 18 2019, 05:52 PM


Group: Member
Posts: 116


Back on March 22nd LevelHeaded2000 (“LH2”) posted an interesting article commenting on some of the content of the CUV Newsletter of 10 January announcing release of the original PDUFA date. Also included in the post were observations based upon a selection of extracts from FDA approval procedures. The essence of the post was that, “….. Clinuvel already has Priority Review however I believe they also have Expedited Review within the Priority review designation. “ LH2 went on to point out that the goal of an ‘expedited review’ is to approve the drug at least 1 month before PDUFA goal date, “provided that no significant application deficiencies prevent an early action.”

We now have reason to believe [ thanks to the excellent research carried out by JohnnyH] that the PDUFA date was subsequently deferred until 6 October 2019 due to work still to be completed by EVONIK in relation to FDA production process queries.

The purpose of this posting is to seek clarification or an opinion from LH2 [or other person(s) who might care to respond], as to whether it is still possible CUV could be granted approval at least 1 month before the revised PDUFA date notwithstanding the delay caused to the originally proposed date due to there being a, “significant application deficiencies [to] prevent an early action.

If this is still the case, then perhaps we could be in for a double whammy in or around 6 September (3 weeks away) when the post-marketing authorisation commitments are due!
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Farleap11
Posted on: Aug 16 2019, 04:01 PM


Group: Member
Posts: 116

It must be getting close to release of the NICE rehearing decision, surely! A positive result would surely help offset the current price erosion. lmaosmiley.gif
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Farleap11
Posted on: Jun 21 2019, 11:43 PM


Group: Member
Posts: 116

Big congratulations to Frogster for the work he did in relation to trading volumes. In his post on Tuesday he came up with a projected turnover of 1,515,054 shares on the last trading day prior to the effective date for entry into the ASX200 which of course was today. As we now know the actual figure turned out to be an unbelievable 1,868,813 some 300,000 above what I thought at the time was an ambitious expectation.

As had been said by many posters on this board in the past, it is the variety of opinions and amount of research that can be found here that makes it such a valued source of information.

I am looking forward to next week when I expect the share price to break through the $40 benchmark for the first time (on Monday). GLTA
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Farleap11
Posted on: Jun 19 2019, 09:29 PM


Group: Member
Posts: 116

Not sure what you are getting at NTC? Latest data on my monitor shows Ur9 listed as sitting on E23.28 (+0.34 or 1.48%) OR A$37.95 (+ A$0.62) as at what is shown as being at 12.48pm in the trading day.

They closed yesterday at E22.94 OR A$37.33 which was below yesterday's ASX close of A$38.70. Today's ASX was up another A$0.25 at A$38.95. It seems that they are currently trailing behind the ASX price but as you can see from the above numbers, that was also the case yesterday for UR9. Have I missed something here? Pardon my ignorance but what does 4% below Pari mean?
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Farleap11
Posted on: Jun 17 2019, 10:50 PM


Group: Member
Posts: 116

The following table of rates has been prepared as an indication where my gut tells me the price could be headed based on a positive PDUFA outcome. I have tried to use past price movements as a guide and decided to post the outcomes to hopefully generate some discussion as to what others might think. Very happy with the outcome of todays trading and being an optimist, I like to think we can expect to some more of the same as we move towards October 6 – a Sunday by the way, with some drop off in price between around mid-July through to towards the end of September as we get closer to the PDUFA date.

[Qualifying Note Just in Case - It is likely this post will only make sense if the setting out holds true and in this regard I have fingers crossed. sadsmiley02.gif ]

CUV Price variations associated with movement into the ASX 200 and ASX 300 being as follows:

1. Announced as addition to ASX 300 on 07.09.2018 with effect from 24.09.2018
2. Announced as addition to ASX 200 on 14.06.2019 with effect from 24.06.2019

ASX 300 ASX 200

Thurs 06.09.2018 – Day prior to announcement: A$14.56
Fri 07.09.2018 – Day of announcement: A$15.38 (+$0.82)
Mon 10.09.2018 – 1st Full Trading day after: A$18.34 (+$2.96)
Mon 01.10.2018 – 3 weeks later: A$22.00 (+$3.66)
By Wed 01.11.2018 - A$17.15
From Nov to 31 Dec 2018 [High A$21.24: Low $14.70] A$18.10
*********************************************************
Thurs 13.06.2019 – Day prior to announcement: A$33.79
Fri 14.06.2019 – Day of announcement: A$34.10(+$0.31)
Mon 17.06.2019 - 1st Full Trading day after: A$36.49(+$2.39)
Mon 24.06.2019 - 1 week later [? A$40.00?] #
Mon 01.07.2019 - [? A$43.50?] #
Between mid-July – late Sept anticipate a fall back in price with a low of [? A$38.00?] #
Mon 30.09.2019 - [? A$41.50?] #
Fri 04.10.2019 – Last trading Day prior to PDUFA [? A$43.00?] #
Mon 07.10.2019 – 1st Trading Day following positive PDUFA [? A$48.00?] #
Fri 01.12.2019 – 4 weeks after positive PDUFA [? A$65.00?] #
***************************************************************************
NOTES: # = Speculative forecasts: All rates listed represent day close prices.

Here goes !!!!

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Farleap11
Posted on: Jun 13 2019, 10:51 PM


Group: Member
Posts: 116

It seems there was an 'after close' trade (45 mins after close) of 42,423 shares @ A$33.79 recorded late this afternoon! Could this be someone in the know re tomorrow mornings announcement re ASX 200 or simply a confident punt by an optimistic supporter huh.gif ?
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Farleap11
Posted on: May 27 2019, 10:36 PM


Group: Member
Posts: 116

Germany has hit a new all time high (ATH) of E20.98 or A$33.91 along with ASX new ATH today of A$33.90! Will CLVLY follow suit later this evening / tonight?

I have decided I am going to just go with the flow and enjoy the ride. That aside, it is my intention to await the ASX200 decision outcome, which if successful can reasonably be expected to result in a further price increase, and if this does happen, I will give serious consideration to taking some more profits in the period prior to release of the PDUFA date but not later than the end of June in case of an early decision.

I should add here that I fully expect FDA to issue an approval notice; however, taking some additional profit as a precautionary measure seems to me to be the prudent thing to do.

GLTA and may the present build in price continue for another 12 - 24 months (or more)!
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Farleap11
Posted on: May 18 2019, 08:26 AM


Group: Member
Posts: 116

It would be hard not to be satisfied with the way the stock performed both internationally as well as from a pricing perspective. I have prepared the following summary to highlight the overall impact:

Another busy and productive night in both Germany and the US. New All Time High (ATH) price benchmarks set at each location.

UR9 – Up A$1.22 [that’s A$5.55 for the week] to – A$31.70 . Turnover for the day = 20,013 compares to the general average of 12,032. Trading range was between A$31.35 and a new ATH of A$31.78!

CLVLY – Up A$1.16 [that’s A$5.26 for the week] to – A$31.66 Turnover for the day = 30,065 (58 trades at average 518 per trade) against the general average of 10,724. Trading range was between A$31.35 and a new ATH of A$31.73.

These numbers compare to yesterday’s ASX closing price of A$31.46 which was up A$5.46 for the week after also hitting a new ATH of A$31.75

Like all other contributors on this board, I am enjoying the ride at present biggrin.gif
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Farleap11
Posted on: May 16 2019, 05:20 PM


Group: Member
Posts: 116

I too have been monitoring Avita's progress which has seen its SP rise from A$0.12 at the beginning of October 2018 to its closing price of A$0.49 today. Is it practicable or even possible for the companies to work together on a cure for Vitiligo without need for a merger / takeover by one or the other?

This might be a naïve question; however to date, I have resisted the temptation to buy into AVH (and paid a price) based largely on the fact that their total shareholders number currently stands at a whopping 1.86 billion - it was 1.37 billion when I first started following them shortly after they were granted FDA approval for the treatment of severe burns using their 'Recell" system on 21 September 2018. This compares to our (CUV) 48m shares base.

The differences between current share prices and shareholder numbers are significant and would seem to me (more a gut feeling than factual knowledge) to make a merger very complicated one.

Anyone care to comment please?



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Farleap11
Posted on: Apr 16 2019, 02:17 PM


Group: Member
Posts: 116

And doing remarkably well at that! Nearmap was touted along with CUV as a probable 'next cab off the rank' based on their similar performance trajectories back in March.
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Farleap11
Posted on: Apr 4 2019, 05:14 PM


Group: Member
Posts: 116

Must be getting close to release of the NICE appeal outcome! Any suggestions re timelines for such events?
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Farleap11
Posted on: Mar 22 2019, 04:14 PM


Group: Member
Posts: 116

Thank you for such a thorough and informative post LH2000. It is one of the many reasons anyone invested in CUV should visit this board on a regular basis. I am in full agreement with your conclusions. Fluctuations in the price are merely a sideshow to the real story. For all of the points raised in yesterday's newsletter, we are in for a wild ride over the next twelve months.
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Farleap11
Posted on: Mar 22 2019, 04:14 PM


Group: Member
Posts: 116

Thank you for such a thorough and informative post LH2000. It is one of the many reasons anyone invested in CUV should visit this board on a regular basis. I am in full agreement with your conclusions. Fluctuations in the price are merely a sideshow to the real story. For all of the points raised in yesterday's newsletter, we are in for a wild ride over the next twelve months.
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Farleap11
Posted on: Mar 8 2019, 04:20 PM


Group: Member
Posts: 116

I was happy to see that the ASX price only dropped A$0.70 to close at A$27.20 notwithstanding the sizeable turnover of 131.8k and missing out on the ASX 200 this time around.

As has been reiterated by other posters here, there are still a number of other potential 'price joggers' in the pipeline.
  Forum: By Share Code

Farleap11
Posted on: Mar 4 2019, 02:51 PM


Group: Member
Posts: 116

I think you are being a wee bit harsh here MacGyver. Sure there is nothing new here for the avid followers on this board - in fact much of it seems like an endorsement of the materials/assumptions used by Sphene Capital to support their conclusions; however, one of our general concerns/criticisms has been the lack of promotional activities to spread the word about our amazing Company over the journey.

Now that we are starting to get runs on the board and the level of interest seems to be growing, my guess is that they have taken the initiative and cobbled together what amounts to an up to date briefing on where we are at today to help satisfy the very real possibility of even more interest from those less knowledgeable than those on this board should CUV be added to ASX 200 on Friday as alluded to by KRD in his recent post.

At this point I would be prepared to endorse pretty much anything they decide/produce given the present level of trading from both a volume and price point of view. As has been said by other posters, if we do not get the nod on Friday, we will get it in June. In closing I simply say that I am over the moon with where we sit at the moment and cannot wait for 8 July to roll around. GLTA
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Farleap11
Posted on: Feb 26 2019, 09:29 AM


Group: Member
Posts: 116

Correct Schlitzo !
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Farleap11
Posted on: Feb 19 2019, 08:22 PM


Group: Member
Posts: 116

And the ASX new day high closing price reached was A$24.71 after hitting a new all time high of A$24.80 during the day. The current UR9 price is also sitting at a new all time high price of A$24.64 surpassing yesterday's record of A$23.53.

And just to complete the picture the CLVLY closed on both Thursday and Friday in America at its all time high rate of US$16.70 (A$23.39 using Friday's exchange rate). Monday was a public holiday so it will be interesting to see if this renewed level of enthusiasm continues in their trading when the open later today.

Given the decision regarding elevation to the ASX200 is fast approaching, I thought it worth revisiting the impact of elevation to the ASX listing on CUV's price. On Thursday 6 September 2018, CUV closed at A$14.56; the decision to move into ASX 300 was made on Friday 7 September; on the following Monday the price increased and closed at A$18.34 on the back of exceptionally high turnover of 231,076 for the day. The price remained within the A$18 range with above average turnover for the next two weeks to 24 September before moving up again into the A$22 range.

Another A$4.00+ uplift to take the price to around the A$30 mark following approval to move into the ASX 200 would be most welcome. I appreciate there are numerous factors that need to come to the fore for this to happen not the least being a favourable decision on the 8 March. Either way, it has been an enjoyable ride and I for one am enjoying the current status - fingers crossed and I say - onwards and upwards from here!!
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Farleap11
Posted on: Feb 19 2019, 03:21 PM


Group: Member
Posts: 116

Spot on 👍😜🏋️‍♂️🏋️‍♂️
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Farleap11
Posted on: Feb 19 2019, 08:19 AM


Group: Member
Posts: 116

However UR9 did close at a new 52 week (all time?) high overnight👍😜
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Farleap11
Posted on: Feb 7 2019, 09:28 PM


Group: Member
Posts: 116

I am not sure why but Mr Babul's paper dated 6 February 2019 makes reference to the 2017 NICE decision not to recommend reimbursement for Scenesse as an EPP treatment, and goes on to say that this ruling was upheld in 2018 on appeal.


My understanding of the situation from a Clinuvel Company Announcement on the 10 October 2018 is that CUV's Appeal against the NICE recommendation was upheld and that the matter was to be referred back to the Highly Specialised Technology (HST) Committee for further review.


Whilst revisiting the 10 October announcement, I noted that it went on to point out that - " No further appeal avenue is available under the NICE Appeal Process, however consultees [CUV and 3 other EPP representative bodies], have up to three months to apply to the High Court for judicial review." In addition in a follow up 'Pink Sheet' report dated 12 October 2018, Dr Wolgen is quoted on page 3 as saying that, " Clinuvel's position is to wait but not too long, to see if NICE takes the initiative [to make reasonable adjustments after revisiting their original recommendations],. If not, then our path is still open for applying to the High Court for a judicial Review. In fairness, we could wait a couple of weeks, but certainly not months." He said the company "could apply for a judicial review tomorrow but we should give them a chance to come back to us. we have three months to appeal - I don't think we should wait that long, but I am open to their phone call,"

The next reference I could find to what happened after these October 2018 announcements is contained in the last paragraph of the Philippe Wolgen Communique dated 15 January, which reads in part, " ...Clinuvel is still in process of requesting NICE to respect the EMA's outcome (marketing authorisation: October 2014) and make Scenesse available to British EPP patients. we will keep you informed later this quarter as we expect news from NICE/NHS England around this time. " It seems clear from this that the process is ongoing; however it does beg the question as to whether the three month count down for a High Court for a judicial Review begins from the date of the initial NICE decision or from when the review decision of the NICE/HST Committee is announced? Logically one would think that it should be 3 months from the date of the final decision i.e. after further review. However Wolgen has sowed a seed of doubt in my mind when he says that the company, "could apply for judicial review tomorrow. etc. ..

Can anyone enlighten me please !


And yes Clinhope, I was surprised but pleased with todays closing price on the ASX. I think it is being influenced to the increasing speculation surrounding entry into the ASX 200 (or not).
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Farleap11
Posted on: Jan 31 2019, 08:47 AM


Group: Member
Posts: 116

Quarterly results out!
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Farleap11
Posted on: Jan 14 2019, 01:19 PM


Group: Member
Posts: 116

I was just short of reaching panic mode! What could ever replace the access to such a diverse range of opinions and general information on CUV!

Thankfully JohnnyT as you point out, we are back in action and on song(s) once again.
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Farleap11
Posted on: Dec 12 2018, 01:49 PM


Group: Member
Posts: 116

84,340 @ A$16.40 !
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Farleap11
Posted on: Dec 12 2018, 01:47 PM


Group: Member
Posts: 116

Somebody thinks CUV is worth buying - a trade of 84,340 units went through a short time ago!!
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Farleap11
Posted on: Dec 12 2018, 08:11 AM


Group: Member
Posts: 116

Thanks for this Sharelooker. Seems like more delays with yet another 'public oral hearing' being a real possibility to independently review the pros and cons of the proposed treatment. No Christmas present likely this year.
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Farleap11
Posted on: Dec 3 2018, 03:00 PM


Group: Member
Posts: 116

An interesting article re CUV under the heading Is CUV's Balance Sheet a Threat to its Future? Whilst I did not get much out of this aspect of the article, I found the section on valuation interesting - $29.70 versus Friday's close of $17 !!


Thought it worth sharing.

https://finance.yahoo.com/news/clinuvel-pha...-011438621.html
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Farleap11
Posted on: Nov 30 2018, 04:51 PM


Group: Member
Posts: 116

Are you able to supply a copy of the last 10 minutes or a sample of trades towards the end of the day Billy ?


I have to now concede that my 'gut feeling' was off the mark! I think what Clinhope has outlined makes sense and I'm going to jump on his band wagon from here on in.
  Forum: By Share Code

Farleap11
Posted on: Nov 29 2018, 02:38 PM


Group: Member
Posts: 116

I have been telling anyone that is prepared to listen that I have had a gut feeling since the AGM last week, that we would receive a notice by the end of this week/month! Am fast running out of time though!

Agree need to keep fingers and toes crossed in the hope we don't all end up like marmas! GLTA - Prepare for Champers tomorrow evening!! biggrin.gif
  Forum: By Share Code

Farleap11
Posted on: Nov 20 2018, 08:35 PM


Group: Member
Posts: 116

Given what has been going on with the share price and the fact that the AGM is on tomorrow, I thought I would look back at what the situation looked like before and after the AGM last year. The results are as follows:

1. During the month of October 2017 the share price hovered in the high $6.00 range – began the month at $6.70, touched $7.00 ( highest being a month high $7.14) before finishing the month at $6.99.
2. November very quickly moved through the $7.00 range reaching $8.48 as early as 6 November 2018 and by 23 November had advanced to $9.12.
3. On the day before the AGM - Monday 27 November 2017 - the closing price was $9.16
4. In the absence of anything significant from the AGM, the remaining two trading days in November resulted in the price falling back to a close of $8.05.
5. In December prices traded mostly in the mid to high $7.00 range before jumping back up from a closing price of $7.82 on 27 December 2017 to $8.20 on the last trading day for year - 28 December 2017.

What can we take from these numbers? Not much I suppose other than the fact we have seen an overall closing price increase of $7.62 between the “day before AGM prices” in 2017 and 2018 based mainly on revenue / profit growth and the successful lodgement of an NDA with the FDA.

The comparable numbers for October into November this year read as follows:

1. The 1 October 2018 closing price was $22.00 followed by a steady decline back to a month low of $15.40 on the 30 October before jumping back up to a close of $16.00 on 31st – Down $6.00 for the month!!
2. November has been up, down and all over the place jumping up $1.15 to a close of $17.15 on the 1 November; continued climbing to a month high (so far) of $21.24 reached a week later on the 8th followed by a steady decline since to close at $16.78 today an increase of $7.62 on last year’s closing price on the day before the AGM.

What will we learn about the road ahead at the AGM tomorrow and what impact is it going to have on the share price during the rest of this month / December and beyond?

Fingers crossed & GLTA
  Forum: By Share Code

Farleap11
Posted on: Nov 13 2018, 11:04 PM


Group: Member
Posts: 116

Not sure at this stage S/L. Will make some further enquiries tomorrow unless someone else provides an answer in the meantime.
  Forum: By Share Code

Farleap11
Posted on: Nov 13 2018, 12:17 PM


Group: Member
Posts: 116

I have just realised that this interview is to follow an earlier 20 minute presentation given this morning in Melbourne with "Scenesse" as the topic at a "Bio Connections Australian Conference" held at the Pullman Melbourne on the Park!
  Forum: By Share Code

Farleap11
Posted on: Nov 13 2018, 11:47 AM


Group: Member
Posts: 116

For those of you located in good old Aussie - land and who have access to paid TV, I have received advice from a reliable source that CUV's CEO is to be interviewed on Sky Business at 2.00pm Melbourne time today!


It will be interesting what he has to say given the AGM is only a week away.
  Forum: By Share Code

Farleap11
Posted on: Oct 3 2018, 04:08 PM


Group: Member
Posts: 116

AGM announced for 10.00 am 21 November 2018 !!
  Forum: By Share Code

Farleap11
Posted on: Sep 27 2018, 02:45 PM


Group: Member
Posts: 116

I' m with Johnnytech -

With FDA approval today, $70.
With unknown FDA result, $65.
With FDA denial, $35. Less than $35, vote to hold and wait for another attempt.
  Forum: By Share Code

Farleap11
Posted on: Sep 21 2018, 03:44 PM


Group: Member
Posts: 116

Thanks for this Investec. The level of assistance that can be achieved from so many differing perspectives on this board never ceases to amaze me - much appreciated and GLTA in these prosperous times.
  Forum: By Share Code

Farleap11
Posted on: Sep 21 2018, 03:05 PM


Group: Member
Posts: 116

Given you have raised SPL, perhaps you can help me understand the following.

CUV on the ASX is currently trading within the same price range as shares traded in America and Germany - respective comparisons being A$18.40 to around A$1850 mark as I enter this message: CLVLY closed at A$18.72 last night; UR9 closed at $18.32. They are most often within the same ball park in terms of pricing.

SPL on the other hand is currently trading at around A$!.45 - A$1.50 mark. Why is the rate so different to the American counterpart SPHRY which closed last night at US$10.76 which converts to around A$14.77? What is that CUV stocks carry a similar value regardless of which country they are trading which seems to be the complete opposite of Starpharma Holdings shares?
  Forum: By Share Code

Farleap11
Posted on: Sep 20 2018, 04:43 PM


Group: Member
Posts: 116

Yes VH - bordering on ridiculous. jumped up 6c beyond the then asking price at close of A$18.35 to formally close at A$18.41. Turnover shares for the day = 43,290 from 2,085 trades which equals an average 21 shares per trade!!!
  Forum: By Share Code

Farleap11
Posted on: Aug 20 2018, 01:43 AM


Group: Member
Posts: 116

Thanks for this information Investek.
Do you or any other posters have any feedback on how the presentation by Dr Henry Lim at the “ World conference of Cancers “ held in Sydney last Thursday went?
Did anyone on this board attend?
  Forum: By Share Code

Farleap11
Posted on: Aug 15 2018, 03:52 PM


Group: Member
Posts: 116

Does this mean that if the CUV NDA application is not granted PR then on the averages we could be waiting for a decision until around this time next year??
  Forum: By Share Code

Farleap11
Posted on: Jul 31 2018, 03:31 PM


Group: Member
Posts: 116

Thanks AJ - it seems I have some reading up to do and have added it to the information on NICE submissions kindly provided by FarmaZ earlier today.



  Forum: By Share Code

Farleap11
Posted on: Jul 31 2018, 11:52 AM


Group: Member
Posts: 116

Was this through normal trading or ‘off market” Billy B ?
  Forum: By Share Code

Farleap11
Posted on: Jul 30 2018, 06:11 PM


Group: Member
Posts: 116

I have a note recorded from earlier postings on this board that the NICE appeal panel was due to convene today Monday 30 July at Nice premises in London to hear oral presentations from the four appellants.

I am not across how this process works and or how/when we can expect a decision. Any information re the outcome of these appeals would be most welcome be it good news or otherwise.


I would expect that a positive outcome on top of todays financials would give the share price an additional boost, not forgetting of course the huge benefit a positive outcome would be for the EPP patients involved.
  Forum: By Share Code

Farleap11
Posted on: Jul 19 2018, 04:49 PM


Group: Member
Posts: 116

Should we be reading anything into the fact that it is the Singaporean arm of FIL that has elected to sell which just happens to be the home of Valleaurex now 100% owned by CUV?
Do the walls have ears ? Or am I being paranoid?
  Forum: By Share Code

Farleap11
Posted on: Jun 22 2018, 04:09 PM


Group: Member
Posts: 116

Both subjects meaning the NDA and new products!
  Forum: By Share Code

Farleap11
Posted on: Jun 22 2018, 03:59 PM


Group: Member
Posts: 116

Could there be any connection to the reference to "NEW PRODUCT DEVELOPMENT" in the 14 May 2018 Company Announcement headed "Clinuvel regulatory Update", wherein it stated in part,

" ...The scientific focus is currently on the development of complimentary non-prescriptive products as well as follow on products to address unmet medical need in severe genetic disorders. The first product line is expected to be announced in July 2018 following the completion of NDA submissions".
In addition to developing non-prescription products, the VALLAURIX team is working to establish an appropriate formulation of afamelanotide for pediatric use - SCENESSE ENFANCE - as well as progressing the scientific work towards the novel molecules CUV9900and VLRX001".

that it is the new products aspects of the Company's position that prompted / required the need for a trading halt. In other words a double barrelled announcement that covers both subjects??

  Forum: By Share Code

Farleap11
Posted on: Jun 6 2018, 05:12 PM


Group: Member
Posts: 116

Thanks for this post AJ. I appreciate that the point made about CUV seems to be that our good friend Mr. Homme believes it to be a potential "30 bagger" (Aussie Dollars ?)

As I do not understand the German language and I am sure there are others on this board in the same boat, I was wondering if there were any other points made about recent developments and or expectations regarding next steps etc.


Thanks you in anticipation.
  Forum: By Share Code

Farleap11
Posted on: May 12 2018, 08:41 AM


Group: Member
Posts: 116

The numbers for last night’s trading were as follows:

UR9 (Frankfurt) closed at A$12.81 – down A$0.05. [Range for the day was A$8.09 – A$12.99] Volumes just below average – 10,742 against average 11614.

CLVLY (USA) closed at A$12.93– down A$0.05 [Range for the day was A$12.66 – A$13.04] Volumes just below average – 2,664 against average 3,298.

These numbers compare to CUV (ASX) closing price of $12.90 yesterday.

They also suggest to me that as in past similar situations with CUV pricing, the SP has reached that point where they are likely to hover around or just below the A$13 mark pending the release of further news.

  Forum: By Share Code

Farleap11
Posted on: May 10 2018, 08:34 AM


Group: Member
Posts: 116

The numbers for last night’s overseas trading were a bit mixed although both are holding above the A$13.00 mark:

UR9 (Frankfurt) closed at A$13.06 – down A$0.33. Volumes continued at above average levels at 20,115 against average 11,260.

CLVLY (USA) closed steady at A$13.16 – down A$0.01 although this was due to increase in A$ against $US. In actual fact the closing price in US currency increased by US$0.01 at an equal 52 week high of US$9.82. Volume was well down on recent days at 1,017 against average of 3,362.

These numbers compare to CUV (ASX) closing price of $12.90 yesterday.

Should be another interesting day ahead.
  Forum: By Share Code

Farleap11
Posted on: May 8 2018, 08:52 AM


Group: Member
Posts: 116

Final numbers for last night’s trading were encouraging :

UR9 (Frankfurt) closed at A$13.24 – up A$0.85 after hitting a new 52 week (all time?) high of $13.25. This was on the back of exceptionally high turnover of 34,384 shares against average 9,917.

CLVLY (USA) closed at A$12.90 – up another A$0.68. That makes an all up increase of A$1.30 since and including Friday. Volume was exceptionally high at 15,515 against average of 3,085.

These numbers compare to CUV (ASX) closing price of $12.55 yesterday.
  Forum: By Share Code

Farleap11
Posted on: May 7 2018, 10:43 PM


Group: Member
Posts: 116

Things are definitely on a roll at the moment. Germany UR9 trading as at 2.01pm shows a turnover up to that point of 34,384 shares against a daily average of 9,917 with the current price trading at E8.25 which equates to $13.10 Aussie dollars !!!
  Forum: By Share Code

Farleap11
Posted on: May 7 2018, 10:55 AM


Group: Member
Posts: 116

Has hit $12.48 on turnover of 25305 shares. New record high since November 2010, 10:1 share consolidation/restructure!!!!

Go you good thing!!
  Forum: By Share Code

Farleap11
Posted on: Apr 30 2018, 03:20 PM


Group: Member
Posts: 116

What’s going on - after hitting A$12.10 earlier today, the price currently on $11.10???
  Forum: By Share Code

Farleap11
Posted on: Apr 20 2018, 03:35 PM


Group: Member
Posts: 116

Valid point the near future; however not sure that I have the discipline to do that especially when there is so much to come in the program ahead.
I too have been on this road for a long journey and sincerely hope that you are right about the next two years.
GLA
  Forum: By Share Code

Farleap11
Posted on: Apr 20 2018, 12:34 PM


Group: Member
Posts: 116

ASX CUV has just achieved 12 Month (all time?) high of A$10.70 !!! Doing ok during the course of this week; however can the increase in price continue in the absence of any concrete news release?
  Forum: By Share Code

Farleap11
Posted on: Apr 18 2018, 10:46 PM


Group: Member
Posts: 116

You might be on to something xray - On top of the todays enthusiasm on the ASX, UR9 (Frankfurt) turnover of shares as at 1.32pm was 57,639 against a daily average turnover of 7711 !!
  Forum: By Share Code

Farleap11
Posted on: Apr 18 2018, 01:13 PM


Group: Member
Posts: 116

means that CUV through its "protected rights" (?) to the use of Afamelanotide is a potential rival for at least some of the treatments that Questcore is currently marketing ACTHAR as the best available treatment?

PS Apologies for the split post - I seem to have pressed a wrong key!!
  Forum: By Share Code

Farleap11
Posted on: Apr 18 2018, 01:07 PM


Group: Member
Posts: 116


Thanks for this post PD. I found the history surrounding ACTHAR leading up to its acquisition by Questcor to be quite enlightening in terms of the way its discovery and usage has evolved of the many years. I assume from the following extract from this particular link:

"ONE big uncertainty hanging over Questcor is competition. As an old drug without patent protection, Acthar would seem to be a sitting duck for generic rivals. And other versions of ACTH have been sold in the past.
  Forum: By Share Code

Farleap11
Posted on: Apr 11 2018, 05:31 PM


Group: Member
Posts: 116


It is certainly a good find; however, given the absence of any formal announcement I am wondering whether the words -

"Currently, the Food and Drug Administration is reviewing the innovative pharmaceutical product for release in the United States."

might simply be a reference to the ongoing interactions between CUV and the FDA as part of the filing processes on a module by module basis. Don't get me wrong I would love it to be a reference to the submission having been complete. Unfortunately it is just another of the many open ended clues that we are left to interpret for ourselves.

It has been and continues to be a long journey.

By the way PD, I followed up on our postings from yesterday regarding the 2013 (?) UK announcement "New Advances" in Vitiligo therapy by going to the UK Vitiligo Society home site and it seems to me that they may well be continuing to chase their tails. references are made to a nine month trial process and the need to complete a full history of events in a log book apparently developed for use during the trials. It is not absolutely clear that these ongoing trials are a continuation of what was to commence in 2014 or a new program. Reading between the lines however, it seems that many of the participants need continuing encouragement due to the lack of results.
  Forum: By Share Code

Farleap11
Posted on: Apr 11 2018, 12:17 AM


Group: Member
Posts: 116

It would seem from my reading of this report that whilst there is no specific mention of when it was released that it must have been published back in 2013. For example reference is made on page 8 to their intention to start recruiting in ten hospitals across the UK in 2014.

I note also that as you point out PD, they make no mention of "afamelanotide plus NB-UVB"; however reference is made to afamelanotide in the 5th paragraph on P.8 under the heading, "Impact on Vitiligo" wherein it states (in part), "...and new research programs have been started looking at the role of afamelanotide... for the treatment of Vitiligo."

Later in P.17 dealing with , "New Advances in Vitiligo Treatment" , they report that they will be embarking on a full scale trial involving 440 patients with Vitiligo across the UK to compare the use of steroid ointments applied to the skin with hand held NB-UVB light therapy and the combination of both steroid ointment and NB-UVB light therapy together.

So whilst there is no mention of afamelanotide plus NB-UVB as a combined form of treatment, the report does make mention of the two treatments in separate sections but not anywhere in a combined form; instead they planned to look at the use of steroid ointment and NB-UVB light therapy together.

Given my limitations when it come to most of the technical aspects of these matters, I would like to ask : -

(a) whether you know of any outcomes from these research programmes being published given they were to begin around 4 years ago or are they still chasing their tails as you so aptly put it ; and
(b) regardless of the answer to (a), whether CUV has exclusive patented coverage for the eventual introduction ( I am an optimist) of afamelanotide plus NB-UVB treatment - in other words cannot be beaten to the goal as they say ( I believe this to be the case but would appreciate confirmation.)


As a general unrelated comment - very pleased with the fact CUV has been holding at around the $10 mark for the past three weeks and will be more pleased when submission of the NDA is confirmed.



  Forum: By Share Code

Farleap11
Posted on: Mar 16 2018, 12:28 PM


Group: Member
Posts: 116

Could it be that the spike in today's share price is the result of another Florian Homm release / report on CUV ? Just wondering - can anyone help with this possibility?
  Forum: By Share Code

Farleap11
Posted on: Feb 9 2018, 07:51 AM


Group: Member
Posts: 116

Could somebody post a copy of todays ASX pre-opening list of buyers & sellers please ? Further significant drop in the DOW overnight (Aus time) suggest another bad day for stocks on the ASX. CUV has maintained a reasonable position through recent downturns; question for today is - Can it do it again today??
  Forum: By Share Code

Farleap11
Posted on: Jan 19 2018, 10:01 PM


Group: Member
Posts: 116

Special thanks to PunkassDerm & Investek for the work behind your recent postings. Your contributions (along with many others e.g. Farma; Royco & many others) make it worthwhile keeping up with CUV issues to an extent that for those of us not particularly knowledgeable in the technical aspects are able to continue to learn in a way that is not otherwise readily available.

Keep up the good work.
  Forum: By Share Code

Farleap11
Posted on: Dec 21 2017, 02:11 AM


Group: Member
Posts: 116

Thank you PunkasDerm for these links - they are very informative.
Having now read the 22 page Evaluation consultation document I have a much better understanding of what has transpired. Section 4 - Consideration of the evidence - whilst very detailed maybe even long winded, does not read well from a Company submissions perspective.
The committee has been able to be critical of the company's approach on far too many aspects of the matter before them. Whilst I have no experience with exercises of this nature it seems apparent that the committee has gone out of its way to discredit the company's approach but at the same time the Company seems to have left itself exposed on too many fronts. I would have expected a more co-operative approach by both sides rather than the adversarial attitudes that seemed to result.
I may be a bit naïve when it comes to the technical requirements in these situations, however, this report seems to reflect more of an interest in point scoring against Clinuvel than any genuine interest in finding a solution for EPP sufferers. The counter to this assertion could perhaps be that they were presented with an opportunity to be so critical because of the quality of the material presented to them.
Whatever the reason, I am personally disappointed with the outcome and await with interest to hear what CUV have to say about the process - if anything.
  Forum: By Share Code

Farleap11
Posted on: Dec 20 2017, 11:50 PM


Group: Member
Posts: 116

The last part of the report which reads:


"The appraisal committee agreed that afamelanotide is innovative and has non-health-related benefits, which should be taken into account in its decision-making, but even so it was
unlikely that the drug would be considered a cost-effective use of NHS resources."

seems to me to suggest they have concerns about other side effects i.e. tanning. Should that be a factor or am I missing something?

  Forum: By Share Code

Farleap11
Posted on: Dec 20 2017, 10:23 PM


Group: Member
Posts: 116

Very disappointing result! About the first and only time a decision re CUV matters has been made ahead of the Expected Publication" date which in this case was to be 23 May 2018!!
In addition it seems NICE decided there was no need for the "Committee Meeting :2" which was to take place 20 February 2018. Where to from here??
  Forum: By Share Code

Farleap11
Posted on: Dec 20 2017, 04:39 PM


Group: Member
Posts: 116

Any chance of assistance from anyone with an English version or alternatively an abridged summary of what the report is referring to. My attempts to use translation services on my computer are sometimes successful but less so in my more recent attemots.

Thanks in advance. Reasonable day here in the land of Oz from a closing price point of view - up 54c to $7.85. Friend Homm seems to have given us another kick along at least for the time being.
  Forum: By Share Code

Farleap11
Posted on: Nov 21 2017, 07:03 AM


Group: Member
Posts: 116

I believe that if the shares are held in joint names or as a registered co. you need to be able to produce evidence that you are authorised to represent / speak on behalf of the other shareholders not present.
  Forum: By Share Code

Farleap11
Posted on: Nov 10 2017, 02:27 PM


Group: Member
Posts: 116

It is my understanding Schlitzo (I think from an earlier posting on this board) that this article was released on 17 October 2016. It is also my belief that Florian Homm released an additional article regarding Clinuvel on Wednesday of last week - 1 November 2017.

Can someone else confirm whether this is correct please?

I have a vague recollection that someone posted a link to the release, however it was in German and I was unable to have it translated. If I am correct, maybe a translated version could be posted by someone with more advanced technical skills! Assuming of course that there was an additional release last week.

GLTA
  Forum: By Share Code

Farleap11
Posted on: Nov 4 2017, 10:06 AM


Group: Member
Posts: 116

I too say thanks for sharing this interesting piece of information.

I have read the article a couple of times and get that the idea behind this initiative is to, "help maximise the opportunity for patients to get access to promising treatments through clinical trials when these treatments are otherwise unavailable...
However, there are a couple of references in the article that suggest to me that ability to access treatments, "...by widening the scope of the new Expanded Access Navigation tool", [EANT] is intended for application to critically ill / terminal patients. I say this based on the following extracts from the article:

1. "[i]Previously this tool [being the EANT] was rolled out for drugs that treat cancer[/i]." (end of para 1) Comment: I do note here that it then goes on to say that, "It will now apply to drugs that treat orphan diseases.

2. "..expanded access programs play an important role for terminal patients..... (second para )Comment: I also note that this does not necessarily exclude non terminal patients!

3. In the third paragraph, it refers to, "....a large unmet need for access to investigational therapies among critically ill patients with rare diseases."

My area of doubt is that although widening of the scope of the Navigation Program is said to "..now apply to drugs that treat orphan diseases", will any such orphan disease need to be of a critical/terminal nature in order to be approved?

not saying this is necessarily the case, but thought it worth sharing.
  Forum: By Share Code

Farleap11
Posted on: Nov 2 2017, 09:33 PM


Group: Member
Posts: 116

Are you able to provide additional information eg link and or other information as to where a copy of the newsletter you refer to can be found?
  Forum: By Share Code

Farleap11
Posted on: Oct 27 2017, 05:01 PM


Group: Member
Posts: 116

Whilst I have not yet had a chance to read the report in full, the one thing that did jump out at me was the following extract from PW's statement:

Quote: ".....I expect that the FDA review of SCENESSE will be completed in 2018, pending application for Priority Review..." - RH column on page 5.

This seems to be at odds with the quote that your goodself and ajshare have referred to! On my quick skim of the document (& I am about to go out for the evening) I have not been able to locate the one you have been refering to.

Have I missed something?

Cheers & GLA
  Forum: By Share Code

Farleap11
Posted on: Oct 10 2017, 08:05 PM


Group: Member
Posts: 116

I don't have a problem with the increased activity per se Royco. What I do find boring though is the consistent manipulation of each days trading pattern that has been going on for the last three to four weeks.

The general pattern for each day seems to be set by the share price of the early trades and be followed by blocks of reasonably consistent shares sold in each transaction for the rest of the day.

The other aspect which irks me is that this ongoing process seems to be managed in a way that keeps the share price hovering anywhere between $6.60 and $6.80 although today after watching it trade consistently at $6.80 for the first 250 odd trades, we saw it jump up in late trading to a close of $6.93 at some point during the last 13 trades for the day...

The point I was trying to get across (and maybe not so well) was that the consistency of the pattern observed day after day has become, for me anyway, quite frustrating and boring. Like many others on this board, I probably spend too much time and energy waiting, waiting & watching for my long term investment to deliver another jump in price like that we enjoyed during 2016.

I have become a little impatient about breaking through the $7 ceiling, not just occasionally, but for good.
  Forum: By Share Code

Farleap11
Posted on: Oct 10 2017, 03:54 PM


Group: Member
Posts: 116

26539 shares changed hands over 263 trades for the day = Average per trade of around 100 with a close of $6.93 for the day!! The recent pattern of daily trades has become extremely boring.

Please PW, put a stop to this monotony & provide us (and the market) with something of substance! The September quarter results would be a great start and may be assist the sp to break through - better still, leave behind the $7 barrier.

Sorry folks, I am hoping this whine will help make me feel better!!!!!!

GLTO
  Forum: By Share Code

Farleap11
Posted on: Aug 3 2017, 12:52 AM


Group: Member
Posts: 116

Frogster provided the following results of his research in a post at 5.52pm on the 26 October 2016:

"Australian implant patent till 2025:
http://www.clinuvel.com/en/investors/news-...mulation-patent

US topical formulation patent till 2025 (20 years after filing in 2005):
http://www.clinuvel.com/en/investors/news-...mulation-patent

also
US protection for exclusive use of Afamelanotide for UV protection via defect in MC1R rec..
http://www.asx.com.au/asxpdf/20100630/pdf/31r2nlp65f0p14.pdf

In addition to these patents, if approved in 2017 for EPP in the US there will be an exclusivity for that indication for at least 7 years (2024)......"


Hope this is of some assistance.
  Forum: By Share Code

Farleap11
Posted on: Jul 28 2017, 09:37 AM


Group: Member
Posts: 116

Could somebody please post a copy of today's premarket buy/sell chart - Kiwi, I think you have been the person whom provides the occasional copy.

Tks.
  Forum: By Share Code

Farleap11
Posted on: May 18 2017, 11:06 AM


Group: Member
Posts: 116

Hi Kiwi - What is the "Buy / Sell" looking like at the moment please. I have only limited experience in tracking this 'tool' but it does seem to be a fairly superficial guide that is susceptible to those that manipulate the shareprice,

Cheers
  Forum: By Share Code

Farleap11
Posted on: May 12 2017, 09:36 AM


Group: Member
Posts: 116

Kiwi, would you mind posting a copy todays pre-opening "Buy/Sell" chart please?
  Forum: By Share Code

Farleap11
Posted on: May 8 2017, 08:48 PM


Group: Member
Posts: 116

I feel sure there are many of us who participate on this board who share your views Dr Wally. The effort you put in to share your wide ranging thoughts is appreciated and serves as a timely reminder of why it is we do participate.

I think 'balimike' summed things up quite well with his closing comments, "Well written. Appreciated my end" (as well)!!

  Forum: By Share Code

Farleap11
Posted on: Apr 18 2017, 09:57 PM


Group: Member
Posts: 116


Translation for those that are unable to convert -

Mar 23, 2017 -‎‎ Good news from the neighbouring country: almost all EPP patients have access to (again) Afamelanotid! To Dr. Rocco Falchetto, President of the Swiss society for Porphyria, on the Swiss change.org - petitions page: ‎
‎«With great pleasure we inform you, that prominent health insurance companies have again granted the costs of Afamelanotid its policyholders.» ‎
‎The complete update can read it here: ‎
‎ ‎‎https://www.change.org/p/ein-leben-ohne-sonne-vivre-sans-soleil-vivere-senza-sole-living-without-sun/u/19788317‎
‎also I am one of the lucky ones: after a difficult year without treatment I can experience this spring, again without fear of terrible pain. A big thank you to the many people and organizations that made this breakthrough possible: They hired doctors of Porphyria Center to call the Swiss society for Porphyria, the Alliance of rare diseases in Switzerland (ProRaris), my friends and family and all the signatories of the Swiss petition - to some. ‎
‎Our goal is still to provide access to all our with patients in Germany and in Switzerland. ‎
‎In the hope of soon greetings for all ‎
‎Jasmine ‎""

Today's trading on the ASX was a disappointing result in terms of share price!! Bring on the next newsletter.


‎ ‎
  Forum: By Share Code

Farleap11
Posted on: Apr 6 2017, 02:20 PM


Group: Member
Posts: 116

I have been a regular reader of this board for a number of years now Melanotano and have learned over this period, to ignore any extreme commentary, whether negative or positive on this board as well as the 'games played
by day traders/ market makers. The overriding factor is the effectiveness of the product and with Scenesse this is beyond question. In the main (not exclusively) red tape hurdles have been the major cause of delays to progress of the share price.
Our friend Iggy summed things up quite well when he said,
"....small trades are of no concern to me as they are only a small piece of the larger story that is currently being played out.
History surrounding the CUV share price is littered with periods of inactivity / gamesmanship. It is the big picture and ongoing potential of where this Company is heading that counts- mind you this requires the exercise of considerable patience due to the slowness
of the legislative processes. There are plenty of other longer term opportunities for CUV outside the more immediate focus on EPP treatments.
In my humble opinion you and your partner should hang in there for the ride and grow wealthy (and old) with the rest of us. Do not sell unless personal
circumstances leave you with no alternative.
cool.gif
  Forum: By Share Code

Farleap11
Posted on: Apr 4 2017, 04:29 PM


Group: Member
Posts: 116

I note from the Company Announcement (CA) enclosed with Dr Wally's post at 11.00am and your Patents & Exclusivity publication (P&E), the following two key points.
Firstly, the CA indicates patent protection for Scenesse/Clinuvel applies until "late 2024"!
Second point from the P & E (last para page 1) states that exclusivity is not added to the patent life!
Is it correct to say therefore that IF the FDA were to approve Scenesse in August this year the end dates for both the patent and exclusivity will coincide (near enough) ?
This might be a naïve question, but I see the function of this board as an opportunity to learn from others with more experience and knowledge in this field than me.
My question is - what happens if approval is not granted by the FDA until say October 2018 which, given that "exclusivity is not added to the patent life"
would seem on the surface to mean the exclusivity period can only apply until the end of the patent protection period i.e. "late 2024" instead of the seven year period
to October 2025 that would otherwise apply?
If this interpretation is correct, it will mean that delays to approval beyond "late 2017" result in progressive reductions to the 7 year exclusivity period.
Can someone please confirm this to be correct or alternatively clarify the situation for me please.
  Forum: By Share Code

Farleap11
Posted on: Mar 21 2017, 01:25 PM


Group: Member
Posts: 116

We need to turn the corner from being in the "potential" category before I move into the "dying pappy with a history", category.
As they say, all good things come to those who wait and purely as a matter of principle now I, along with many others on this board I am sure, am determined to hang in for the good times.
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Farleap11
Posted on: Mar 16 2017, 09:46 PM


Group: Member
Posts: 116

Worth noting that exactly 12 months ago CUV closed at $3.50 on ASX.
Let's hope that the rate of price increase (double) repeats over the next 12 months. One would like to think that this is a realistic possibility given what is expected to transpire
within the next 12 months.

GLA
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Farleap11
Posted on: Feb 28 2017, 11:56 PM


Group: Member
Posts: 116

Just a reminder for those that might be interested in tuning in to the Webcast of todays meeting (Wednesday 1 March) between the APF & FDA.
If I have recorded correctly from a previous post on this board, the Webcast link provided was:
https://www.youtube.com/watch?v=AX20OvotxHA.

GLA
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Farleap11
Posted on: Feb 20 2017, 02:58 PM


Group: Member
Posts: 116

I found the following extracts from an article published in The Australian newspaper last Wednesday 15 February to be of interest and worth sharing. My understanding is that it
is a repeat of an article originally published in THE WALL STREET JOURNAL.

Quote Article: PHARMA DELAYS DRUG OVER 'PREDATORY PRICING' -
Marathon Pharmaceuticals will delay the US launch of its expensive muscular-dystrophy drug amid mounting criticism
of its $US89,000 ($116,000) a year price, including from two members of congress who launched an investigation yesterday, and a powerful Republican member of the House of
Representatives...................................
The delay was also announced at a meeting in Washington yesterday of parents with children with Duchenne muscular dystrophy, a rare disease affecting about 12,000 boys in the US.
Marathon received approval [from the FDA.........] to sell the drug, deflazacort, to patients with Duchenne. The drug had not been available in the US previously, but many patients had been
importing it from Britain for about $US1200-$US1600 annually. Some families have raised objections to the new price..........
In a letter to privately held Marathon yesterday, Democrats Bernie Sanders and Elijah Cummings requested detailed information on the company's "outrageous plan to begin charging
$US89,000 per year" for the drug, despite it having been available for decades in Europe at a fraction of the price. [ They have asked ] how much it spent to develop the drug, its revenue and
profit projections and its communications with health insurers about covering the drug, according to the letter dated 13 February. The FDA approval gives Marathon the exclusive right to sell
deflazacort in the US for a period of seven years before competitors can enter the market.......[account approved].... under the Orphan Drug Act, which provides incentives to companies for
developing drugs for diseases affecting fewer than 200,000 patients in the US.
[The letter went on to state..]..."We urge you to significantly lower your price ..before it goes to market next month. Marathon's apparent abuse of government-granted exclusivity periods
and incentives to sell what should be a widely available drug for $US89,000 a year is unconscionable." In its statement, Marathon said it appreciated the chance "to engage in dialogue on
the value of a FDA approval of medicine with" Senator Sanders and Mr Cummings. END Article.

On its face, this article would seem to support the positon adopted by CUV regarding the need for consistency with the rate for Scenesse.


  Forum: By Share Code

Farleap11
Posted on: Feb 14 2017, 04:29 PM


Group: Member
Posts: 116

I think we need to reflect on the more recent gains made with our CUV holdings. As a long time holder of this stock (Epitan Days) I, along with many others have had to exercise a great deal
of patience and unbending belief in what we have invested in. If you look at how the share price has grown over the past 14 odd months and bear in mind all the red tape and with it the extra
administrative obstacles that have had to be overcome/met, we should be more positive about what the Company has achieved. Earlier today, LevelHeaded posted an excellent overview
of why we should be feeling confident about the way ahead.

31 December 2015 – Share price = $2.63
29 February 2016 - $3.70
31 March 2016 - $4.20
18 July 2016 – hit $5.09 (first break through of the $5 target (in the more recent years)
Between 18 July and 10 August, the price shuffled between $5.09 and a low of $4.76
11 August 2016 – Closed at $5.00 and has not been below since
15 September 2016 – Hit $6.02 (first breakthrough of $6.00 target)
Only slipped below $6.00 on 27 & 28 September - $5.96 & $5.70 respectively, before –
21 October 2016 - $7.02 (first breakthrough of $7.00 target)
28 October 2016 - $9.19 (Jumped straight past the $8.00 mark!!

This jump in price was unprecedented and an obvious overreach at the time which of course was always going to be followed by a gradual wind back unless supported by a substantial
new development. Instead we have seen a slowing of sales (which will be overcome with the warmer weather in Europe and gradual take up by recalcitrant / tardy European countries)
reflected in the December quarter financials. Key tracking dates since the overstretch to $9.19 mark have been are as follows:

31 October 2016 to 4 November 2016 – hovered around the $8.50 mark
7 November 2016 – retreated to $7.87;
31 December 2016 closed out at $7.45 (An uplift of almost $5.00 from 12-month before)
2017 – Until this week has traded between a low of $7.30 (on 13 January) and high of $8.21(on 30 January) except for 7 February when it closed at $6.97.

Of course, it would be much more comfortable for us all if downturns in price were not to occur, however it seems it is an unfortunate fact of how the system works and we have to accept
it for what it is, knowing all the while that we are on a winner! Bring on FDA approval I say and lets watch the escalation in price resume.



  Forum: By Share Code

Farleap11
Posted on: Feb 1 2017, 11:01 PM


Group: Member
Posts: 116

Lets hope that the opinion expressed by this particular reporter, namely,

Ït seems to me that Trump is now aligning his statements with the actual policy he is pursuing, namely to speed drug approvals at the FDA ........"

is correct!

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Farleap11
Posted on: Feb 1 2017, 10:58 PM


Group: Member
Posts: 116

Cancelled
  Forum: By Share Code

Farleap11
Posted on: Jan 6 2017, 11:12 AM


Group: Member
Posts: 116

I will stick with my end of 2016 forecast and say $10.63!!
  Forum: By Share Code

Farleap11
Posted on: Dec 23 2016, 03:18 PM


Group: Member
Posts: 116

'Stan the Man' Head Supremo has shed another 898 shares $7.80 per share (if my calculations are correct) - date of change shown as 19 December 2016!!

Hmmm - spare change for a big Christmas celebration toasting CUV progress during 2016?
  Forum: By Share Code

Farleap11
Posted on: Dec 20 2016, 08:57 AM


Group: Member
Posts: 116

I cannot provide a full list of trades for the day; however I can tell you from my own observations throughout the day that at on stage during trading, I noted that the ASX site showed total units traded moving from 2507 @ $7.60 over 30 trades - up to 2512 @ $7.77 over 31 trades. Prior to this 31st trade the figures reported on the ASX site and the CUV Announcements site - sub set "Shares" link, were in line with one another as were the reports displayed on the Bloomberg Markets CUV site.

From this point on however (i.e. when the sales moved to 2512 shares or units traded), both the CUV site and Bloomberg showed the movement of shares traded moving from 2507 to 52512 shares traded and this is when the 50,000 difference in the reports occurred. It stayed this way for the rest of the day. I just checked the Bloomberg site again it it is still showing yesterday's total sales as 60,934. The CUV shares site has a graph illustration that shows sales and if you put your cursor on the end (which is close of trade yesterday) it too confirms the number sold as 60934!

Merry Christmas to all and may we all share in a Happy & prosperous New Year!
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Farleap11
Posted on: Dec 18 2016, 08:20 PM


Group: Member
Posts: 116

Been waiting for someone to seek clarification re your assertion, "....surprise news is coming in the next two weeks. Something out of the box, no take over but something we did not think about."

Curiosity has got the better of me and so I must ask you Near Future - on what basis do you make such a bold forecast? Have I missed something or is it that you are simply 'flying a kite' as they say??
  Forum: By Share Code

Farleap11
Posted on: Oct 9 2016, 09:11 PM


Group: Member
Posts: 116

Further to my earlier posting a short time ago.

I was unable to find anything that confirmed which year this meeting on 30 September occurred and in hindsight it does seem a bit too close to the upcoming events scheduled for 24 October this year. Can anyone confirm whether this is a report of a meeting which took place this year or was it last year.If it was in fact a forerunner to this years 24 October 24th get together then it is safe to say that we are finally working a good "head of steam" !!!!!!!
  Forum: By Share Code

Farleap11
Posted on: Oct 9 2016, 08:58 PM


Group: Member
Posts: 116

I am not sure that this has been posted previously - if it has then I must have missed it.

www.porphyriafoundation.com/.../clinuvel-and-fda-discuss-epp-indication-and-regul...
Clinuvel and FDA discuss EPP indication and regulatory pathways for SCENESSE®. The attached document discusses the latest news from FDA and Clinuvel:.

"Clinuvel and FDA discuss EPP indication and regulatory pathways for SCENESSE®

The attached document discusses the latest news from FDA and Clinuvel:

Type C meeting provides guidance for follow up and further discussions between FDA and Clinuvel.

Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) today announced that on September 30 it met in Silver Spring, USA, with the US Food and Drug Administration's (FDA's) Division for Dermatology and Dental Products (DDDP) and representatives of the Center of Drug Evaluation and Research (CDER). The objective of the meeting was to discuss the US regulatory review of SCENESSE® (afamelanotide 16mg) to be made available to American erythropoietic protoporphyria (EPP) patients. In 2014 SCENESSE® was granted marketing authorisation by the European Medicines Agency as a prophylactic photoprotective drug for adult EPP patients.

The DDDP stated that it was seeking a regulatory pathway to make SCENESSE® available in the US, and the regulatory avenue of Accelerated Approval was suggested, pending FDA's review, analyses and further discussions on available photoprovocation and data on quality of life in EPP patients.

A discussion was held on the drug's benefits to patients who had received SCENESSE®. Expert European and US porphyria clinicians were invited to share their experience in the treatment of EPP patients and the use of SCENESSE® in their patients. Further discussions will be held with the DDDP following the review of photoprovocation and quality of life data."



"Remember....Research is the key to your cure!"


Sep 27, 2016
Recordati Rare Diseases Launches New Website to Help Healthcare Professionals Identify AIP
Sep 21, 2016
Reserve Your Hotel Room for the FDA Meeting for EPP by FRIDAY!
Sep 14, 2016
The Chicago Patient Meeting Is Next Weekend!
Sep 07, 2016
Chicago Patient Meeting Invitations Are In The Mail
» More recent news

  Forum: By Share Code

Farleap11
Posted on: Oct 8 2016, 09:29 PM


Group: Member
Posts: 116

$10.63 - worth noting that as at 31 December 2015 value was $2.63!!
  Forum: By Share Code

Farleap11
Posted on: Aug 15 2016, 10:27 PM


Group: Member
Posts: 116

Don't do that Kiwi - hang in there. There are some among us who appreciate your contributions. We all have our own points of view and it would be a rare thing when you have a mixed bag of optimists and pessimists, to not have a bit of 'niggle' now and again.
  Forum: By Share Code

Farleap11
Posted on: Apr 15 2016, 09:51 AM


Group: Member
Posts: 116

Should have read the Homm response first. Translation is one thing; understanding the meanings behind his comments are another.

I agree he does seem to be saying that Wolgen's shortcomings as a PR agent has worked against the present level of CUV's share price & not sure about him claiming to be the saviour so to speak.
  Forum: By Share Code

Farleap11
Posted on: Apr 15 2016, 09:42 AM


Group: Member
Posts: 116

I am able to translate non English articles by right clicking on my mouse thence selecting 'translate to English"! I assume this is a standard tool on most computers.
Hope this is of some assistance.
  Forum: By Share Code

Farleap11
Posted on: Apr 13 2016, 05:40 PM


Group: Member
Posts: 116


You have to wonder what is going on at times. A parcel of 200 shares was sold at 11.31am bringing the price down from $4.10 to $4.05 & moving total sales for the day up to that point to a grand total of 4317. There were no further transactions reported until 4.10pm when a further 5 - yes five - shares were sold @ $4.00 which became the closing price for the day !!!!

I appreciate that low turnovers can result in misleading pricing and dare I say it, even manipulation!! I look forward with interest to see what level the opening bids start at tomorrow.

Whilst I keep telling myself [and the doubting 'Thomas' / friends that I have convinced to get on board over the journey], that good things come to those that are prepared to wait, I am becoming increasingly anxious. Nevertheless, I am still hopeful that good news is just around the corner.

Good luck to all!

PS Try as I might, limited computer skills have failed me hence no avatar!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
  Forum: By Share Code

Farleap11
Posted on: Mar 29 2016, 04:08 PM


Group: Member
Posts: 116

If my reading of the day's events is correct the last sale for today was 3 shares @ $4.12 reducing closing price by $0.01 from $4.13 !!

That aside I am just happy to see the price continue above $4.00.

Looking forward to good times ahead. smile.gif
  Forum: By Share Code

Farleap11
Posted on: Mar 29 2016, 04:08 PM


Group: Member
Posts: 116

If my reading of the day's events is correct the last sale for today was 3 shares @ $4.12 reducing closing price by $0.01 from $4.13 !!

That aside I am just happy to see the price continue above $4.00.

Looking forward to good times ahead. smile.gif
  Forum: By Share Code

Farleap11
Posted on: Jun 11 2015, 12:01 PM


Group: Member
Posts: 116

Share price down 9.84% to $2.75 this morning on the back of a turnover of 55,212 shares spread among 39 buyers and sellers !!!!!!!!!!!!!!!
  Forum: By Share Code

Farleap11
Posted on: Jun 5 2015, 05:42 PM


Group: Member
Posts: 116

Hi All. This is my first post. Long time shareholder (back to Epitan days) and silent observer of the blogs on this site for about 12 months. I, no doubt like many others who participate / observe the varying submissions to this forum, have found it to be very informative, even if at times a bit circuitous and other times, entertaining. Up until now I have resisted the temptation to involve myself in the exchanges; however, I am intrigued by the comment made by the good man from Portugal, namely:

"What is not said is that there will be someone from the United States (FDA?) in that meeting."

My question to you PM is - Are you stating this as being an actual fact or simply raising it as an interesting possibility?

Given I have now broken the ice so to speak, I would like to also raise another matter that stems from an article by a "Clay Carter" published in the "Wealth" section of the broadsheet newspaper "The Australian" on the 31 March 2015 under the heading, "Biosimilars are making a difference for big pharma". I have extracted what I think are the relevant sections of the article which form the background to my question and they are as follows:

"So what is a biosimilar? A biosimilar is a biological product that, based on rigorous clinical studies, is shown to be similar to an already approved biological product, known as a reference product........ The biosimilar also must show it has no meaningful differences in terms of safety and effectiveness from the reference product.They're not to be confused with generics - where drug companies can make drugs they did not invent because those drugs have come off patent. Biosimilars require far more resources and expertise to develop than a generic drug. Unlike generics, biosimilars need to go through clinical trials to win approval from the FDA............
"It will take time for biosimilar "sponsors" to clear both regulatory hurdles (the FDA) and negotiate (and perhaps litigate) with the innovators of the original indication. However, the genie is out of the bottle and regulatory and intellectual property hurdles are no longer insurmountable, since the FDA is now willing to accept EU and external bridging trials and there is now an acceptable regulatory pathway (351K) for biosimilars in the US. It is the intellectual property hurdle that is the most time consuming and complicated." End quotes

Given the nature of the underpinning principles adopted here for FDA approval of "biosimilars", is it not reasonable to expect that FDA would (should?) also, "... accept EU and external bridging trials.." associated with EMA approval of Scenesse for restricted use in Europe?? Bear in mind I am talking about the principles here. Clearly CUV is the innovator here and not seeking approval for a biosimilar. Scenesse is Scenesse whichever way it is put forward
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