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Verharven
Posted on: Yesterday, 04:30 AM


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Posts: 807

I agree with your post about potentially accelerated approval for XP, though this part is not entirely correct:

"If new clinical trials were unethical in EPP, I think clinical trials in XP would be even more unethical, since a randomized placebo controlled trial would cause cancerous lesions and great pain among the patients in the placebo arm."

When there is no effective treatment for a condition, a placebo is completely ethical to use as you still need to determine if the new intervention is effective so in this case, the placebo represents current best-practice treatment. There have been some cases where these sort of clinical trials have been shown to be so effective mid-trial that they were stopped as to continue on with a placebo group would be unethical. If there was already a drug treatment then this would be the standard of care for the placebo group (so they would still get a dummy implant) that Scenesse would be compared to. This is called a comparator study. If the current treatment was withheld this would be unethical and likely never approved by an ethics board.
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Verharven
Posted on: Oct 18 2019, 04:45 PM


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Yes, the only growth has been in the 1-1,000 group so lots of retail small investors mopping up the crumbs from the bigger holders
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Verharven
Posted on: Oct 18 2019, 10:35 AM


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"On 31 May, the FDA used its discretionary tool to request a three month extension to the formal review user fee goal date, providing a new target date 6 October. We assessed the delay as a positive measure, since the Agency had had ample opportunity to reject the submission, issue a Refusal to File or even request a withdrawal. None of the events had occurred during our submission or review, and our teams kept working towards satisfying all outstanding questions from the agency."
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Verharven
Posted on: Oct 17 2019, 10:50 AM


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Newsletter out. I didn't realise they started issuing German communiques in May 2019 to cater for the large investment community there 👍👍


Attached File(s)
Attached File  Announcements.pdf ( 237.01K ) Number of downloads: 213

 
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Verharven
Posted on: Oct 16 2019, 03:13 PM


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You can always view short data yourself here https://www.shortman.com.au/stock?q=cuv

Went down 0.22 percentage points to now 5.58% for Thursday of last week when there were 160k gross shorts for the day so much more closing of open positions going on rather than opening new positions. Interesting the gross shorts really dropped off yesterday - down to 24k. So i'm seeing a very slow unwinding of shorts overall so SP drop probably more influenced by profit-taking I'd say - that's healthy..
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Verharven
Posted on: Oct 16 2019, 10:00 AM


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Try shorters, profit-takers (good luck to anyone that has cashed some in after such a long wait) and despite all the promo and exposure post FDA decision, people probably look at CUV without the in-depth understanding that most of us have and all they see is an expensive company (based on P/E) with a single drug and a tiny patient population so they haven't bought in..
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Verharven
Posted on: Oct 16 2019, 04:40 AM


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For the benefit of our overseas readers, the two recent interviews posted with Alan Kohler and Tom Pretosky are big 'known names' to the general public. These two guys have very high media profiles as they do daily financial reports on several of the main TV networks so PW has clearly come 'out of the shadows' and is shouting the CUV story to anyone and everyone. Please correct me too, but I believe Alan's Eureka report is one of the biggest subscription services around.
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Verharven
Posted on: Oct 15 2019, 01:45 PM


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CommSec's Tom Petrosky interviews PW - can't fault him for the promo work he's doing post-approval.

https://www.youtube.com/watch?v=39O8oxM1Cn8
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Verharven
Posted on: Oct 15 2019, 12:09 PM


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Short positions are in for Wednesday last week and there was a change of just a decrease of 0.03 percentage points (14k shares) to 5.8%. So any closing out (at likely a big loss) was offset by opening new positions. Rinse and repeat until the magic pudding runs out of pudding.
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Verharven
Posted on: Oct 15 2019, 10:37 AM


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Fourth day in a row of >100k gross shorts. We'll find out this afternoon if there was a net opening or closing of shorts on decision day last Wednesday.
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Verharven
Posted on: Oct 15 2019, 08:33 AM


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He agreed earlier this year to stay on as chair when already was ready to retire in order to see if through until FDA approval. The job is done and this will be his last AGM and then pass the baton on to his successor soon after. I wish him well. Sobering to read how close it was to curtains in the early 2000s as bankruptcy loomed. I would have lost maybe $50k at the time which would have been painful, but I would have moved on. Out of the ashes here we are today and I've just bought a new BMW on the weekend thanks to CUV with 'just enough left over' to buy a couple of houses.....
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Verharven
Posted on: Oct 15 2019, 04:40 AM


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I think they had a hand too in helping Eliud Kipchoge break the 2 hour marathon barrier on the weekend - he used to be white 😂
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Verharven
Posted on: Oct 14 2019, 02:53 PM


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But charting doesn't tell you if there was a legitimate reason for the gap in the first place - a binary event of FDA approval causing a major SP spike is a major rerating event of this company
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Verharven
Posted on: Oct 14 2019, 11:09 AM


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On balance, shorting is a zero-sum game as the selling will always be offset by the buying. You can argue that going long is also a zero-sum game, but with the big difference that timeframes for going long can be years (if not decades for many of us here!) whereas shorting is certainly a short-term game. So what happens between the two sides of the transaction of either short or long is a combination of fundamentals and some degree of irrationality/psychology (hype pushing up the SP and FUD pushing it down) and a dash of manipulation too. You'd only short then if you believe the SP overall was on the way down because of the belief it was overpriced and/or bad news was likely or you want to trigger a sell off, The shorters have FUed up all of these as the fundamentals have been franked by the FDA decision and I see little evidence of the shorting causing a panic pile-in of selling to create the SP direction the shorters need. I mean seriously, those of the many of us here that have been in for many years have seen the terrible times and are now sitting on multi-bagger profits - yeah right, as if any of us would be having sleepless nights if the SP were to drop 20%, 30 or even 40% from shorters. The fundamentals are going to steamroll them every time like it has with the FDA decision but they're yet to line up to take their medicine and close out.
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Verharven
Posted on: Oct 13 2019, 12:22 PM


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Yes, if an acquiring company got enough shares in a hostile bid, they could steer the board, but unless they get >90% of shares then they can't acquire the company. As it is now the board have a blocking stake in any takeover attempt and even if they were ousted, that blocking stake is still there.
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Verharven
Posted on: Oct 12 2019, 04:20 AM


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Posts: 807

Regarding takeovers, no matter how hostile the bid, it has no chance of occurring unless the directors agree to it as collectively they own over 10% of the shares and in order to compulsorily acquire all shares in a company, a bidder must amass greater than 90% of shares from agreeable shareholders before they are able to mop up the rest of them compulsorily. I have no idea what price PW would take, but pretty safe bet it would be 3 digits.
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Verharven
Posted on: Oct 10 2019, 12:36 PM


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Whoa. As they say: "You only find out who is swimming naked when the tide goes out." And the CUV tide is strong so being naked means it's easier to be screwed.
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Verharven
Posted on: Oct 10 2019, 12:07 PM


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And there you have it, shorts back up 2.65 percentage points on Friday, Oct 4 to be back at 5.77% (2.8 M shares). Same thing for NEA so it's some accounting quirk in reconciling the open shorts for these shares that are being algo shorted based on TA rather than fundamentals. It's great news to be at ATHs with little change in the open short positions and likely not much change from yesterday based on the gross data. The squeeze is coming...
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Verharven
Posted on: Oct 10 2019, 10:32 AM


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Only 106k gross shorts yesterday
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Verharven
Posted on: Oct 10 2019, 04:55 AM


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Still waiting for it to appear on the approved list of drugs so we can sift through the entrails of all the juicy approval docs

https://www.accessdata.fda.gov/scripts/cder...sSearch.process
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Verharven
Posted on: Oct 10 2019, 02:31 AM


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I'm calling that short data showing a fall of 2.74 percentage points a data blip error as occurred the same for NEA (the other share the TA algo short traders have been playing with) on the same day and also for both shares on Aug 13. Please take note that the data is 4 trading days old and applies to October 3 so has no relevance to the trading that happened yesterday. That is why the data can't be correct as no way could 1.3 M shorts have closed out on Oct 3 which was a day where 366k shares traded on the market and the SP didn't do much. I'm expecting it to probably bounce back to ~6% tomorrow. Next Tuesday though we'll get the data for short positions as it applied to yesterday's trading and would certainly be expecting to see a decent fall, but the shorters still have some way to go to close out - God bless them all.
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Verharven
Posted on: Oct 9 2019, 04:04 PM


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Division of Dermatology assessment team decision was unanimous. Will be the same team assessing the vitiligo indication.
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Verharven
Posted on: Oct 9 2019, 03:56 PM


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I noted that as being his very last remark before going into Qs - appreciated PW
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Verharven
Posted on: Oct 9 2019, 12:08 PM


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Looks like another data blip error or the like on the shorts as showed a 2.74 percentage point fall for October 3! NEA showed the same data blip.
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Verharven
Posted on: Oct 9 2019, 09:04 AM


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Indicative open is at $40 - will be a massive day
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Verharven
Posted on: Oct 9 2019, 08:48 AM


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And here's the news from CUV. I'll see you all on the teleconference!


Attached File(s)
Attached File  Announcements.pdf ( 151.07K ) Number of downloads: 70

 
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Verharven
Posted on: Oct 9 2019, 07:40 AM


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$30.10 atm, but very little buy and sell volume
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Verharven
Posted on: Oct 9 2019, 03:54 AM


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CLVLF up 26% to USD 23.25 which is AUD 34.54. How would it feel to be holding 2.9 M of open shorts right now?
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Verharven
Posted on: Oct 9 2019, 03:40 AM


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Callback to our famous former Prime Minister Bob Hawke on when Australia won the America's Cup in 1983

https://www.youtube.com/watch?v=s8mdHO2_Zo8
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Verharven
Posted on: Oct 9 2019, 03:30 AM


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Just to make it official, here's the news on the FDA website

https://www.fda.gov/news-events/press-annou...s-rare-disorder
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Verharven
Posted on: Oct 9 2019, 03:20 AM


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Congratulations to the entire CUV team - we've had our criticism of many things you've done over the years, but getting this to FDA approval from the ashes of where it was in the mid 2000s is a true testament to the work and dedication of you all.
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Verharven
Posted on: Oct 9 2019, 02:36 AM


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ASX rules are that THs can only be in place for a maximum of 2 trading days so they all read like this to give the company the full 2 days or until they make an announcement.
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Verharven
Posted on: Oct 9 2019, 02:09 AM


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It's 3 am here in Melbourne and just woke up and no way am getting back to sleep so here joining the 'Night's Watch'. I'm only a 10-minute drive from the head office at this time of the night - wonder if I should make the trip in to see if the lights are on 😂 Good luck to us all
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Verharven
Posted on: Oct 8 2019, 05:50 PM


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Thanks for that update as there was trading volume going through after the TH announcement came through so seems it's shut down now.
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Verharven
Posted on: Oct 8 2019, 05:17 PM


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So we didn't get the nice T-30 days SP run-up though we can thank the shorters for this. What is of interest from this graph is the SP action in the few days before a PDUFA decision. A nice spike up on average in the days prior to when a positive decision comes and a steep spike down on average in the days before bad news hits. The last three days have been very green so taking that as a good omen.
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Verharven
Posted on: Oct 8 2019, 05:06 PM


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Only the ASX - it's trading in Germany right this second. In this instance though news on the outcome will likely be released after the close of the US market so no other borse will get the jump on the news as ASX trading should be happening some time tomorrow once CUV get their announcement typed up.
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Verharven
Posted on: Oct 8 2019, 07:14 AM


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If you put a sell limit at $45 then that is the lowest price that a trade would go through at. If the shares came out of a TH where the SP was below $45 prior to it, then the order would be triggered if the opening single price auction was above $45 at the actual opening price. As for selling any shares if approval comes through, I'll see what the SP action is like but like many here, I believe it will be some months before the price starts to ramp up notwithstanding any single day price spike on approval day.
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Verharven
Posted on: Oct 7 2019, 12:29 PM


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Here's the list of the worth of the top 20 https://en.wikipedia.org/wiki/Forbes%27_lis...s#2018_rankings so if you wanted Newcastle United @ USD381M (AUD654) then based on PWs shares - say he has 4M (correct me if I'm wrong as can't be bothered looking it up) then would be a SP of AUD 141. He probably wants a Dutch team so SP well below that then.
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Verharven
Posted on: Oct 7 2019, 09:19 AM


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So if you knew a negative outcome was coming would you ink a new contract for more years of grind ahead? Or if you knew a positive outcome was coming, sign a new deal so you can build the company and SP further to get your football team in 3 years?
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Verharven
Posted on: Oct 7 2019, 08:04 AM


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Let's hope we'll be singing this on Wednesday

Hallelujah
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Verharven
Posted on: Oct 7 2019, 07:31 AM


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The Week Ahead In Biotech: Pfenex And Clinuvel On The Radar Ahead of FDA Decisions, 2 IPOs On Deck

https://www.benzinga.com/general/biotech/19...-2-ipos-on-deck
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Verharven
Posted on: Oct 5 2019, 04:56 AM


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CUV hits the mainstream - now features in university chemistry assignments

https://www.chegg.com/homework-help/questio...pepud-q40576203
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Verharven
Posted on: Oct 2 2019, 09:46 AM


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FDA 'miscommunicated' the PDUFA date - should have been 8 October which aligns with a 3-month extension from the prior date of July 8. I guess if this error was just picked up at the 11th hour could make the assumption the decision will be coming through on the 8th. This time next week we will know.


Attached File(s)
Attached File  Announcements.pdf ( 131.25K ) Number of downloads: 138

 
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Verharven
Posted on: Oct 1 2019, 06:49 PM


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"Why are so many germans invested in Clinuvel Pharmaceuticals?"

Spoiler alert: Answer is Florian Homm

https://www.youtube.com/watch?v=wlj1L1HSrxU
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Verharven
Posted on: Sep 30 2019, 03:49 PM


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AGM announced for Wednesday 20 November, 10 am @ The Events Centre at Collins Square, Tower 2, Level 5, 727 Collins Street. Let's hope it's a party mood for all attending. It hopefully will be Stan's last AGM so am sure he'll go out with a bang with the jokes.


Attached File(s)
Attached File  Announcements.pdf ( 109.71K ) Number of downloads: 68

 
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Verharven
Posted on: Sep 30 2019, 08:17 AM


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If approval comes through, I was planning on selling a modest parcel of ~20k shares, but have now changed those plans and will hold through because....shorters - want to see them squeezed to an inch of their life to learn them a lesson good. I encourage you all to join in a selling strike if we get approval! 😂
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Verharven
Posted on: Sep 29 2019, 07:24 PM


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June 2003 was when i first bought into CUV (Epitan as it was back then) and picked up 5,000 shares @ $3.40 (consolidation adjusted). Since that time I've made 27 more purchases over the interceeding 16 years. It has been quite the journey as I find myself in possession of far more shares than I could have ever imagined all 'thanks' to the excruciating delays and long time frames that things have happened in which I hope to look back on as a blessing in a bit under a week. This board has maintained my sanity and served as one of the most valuable resources (and support groups) I've known. Good to luck to everyone as we wait to get the news we wish for hopefully in the early hours of Saturday morning Australian time.
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Verharven
Posted on: Sep 27 2019, 04:03 PM


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The 1.82% is the sum total of the % Capital Shorted column which is not correct as the data is non-aggregate and the timeframe is arbitrary - you could do it back for the last year or 5 years or whatever time you like and get a huge number
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Verharven
Posted on: Sep 27 2019, 03:48 PM


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There is no mismatch - the data that matters is the open short positions which trail by 4 days. It looks like you've just added up the gross short column and the % capital shorted over the arbitrary time frame back to 30 August which is not how it is done as you don't just add all this data together cumulatively. Gross shorts give a rough guide to the day's trading as there could be multiple open and closing of positions.
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Verharven
Posted on: Sep 25 2019, 01:13 PM


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And the shorts shoot up to 6.15% (3.01 M shares) as of Thursday of last week. This was the day where there were 160k shares traded on the opening bell and 476k for the day.
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Verharven
Posted on: Sep 23 2019, 02:46 PM


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When you're short, the maximum profit you can make is your initial investment from selling the shares (minus the shorting loan fee) if the company were to go belly up (so don't need to repurchase the shares) while your maximum losses are unlimited. It is not a long-term strategy.
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Verharven
Posted on: Sep 23 2019, 02:15 PM


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Yes and as I write this, CUV is down 3.68% and NEA down 3.56% on a slightly green day for the market. It's TA shorting all the way - they probably have no idea what PDUFA even stands for.
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Verharven
Posted on: Sep 23 2019, 01:17 PM


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Look no further than the shorters to explain all this as the open shorts hit a new all-time high of 5.94% (2.906M shares) as of Tuesday of last week.
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Verharven
Posted on: Sep 21 2019, 05:26 AM


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If the shorter is betting on a CRL then good luck to them as nothing is 100% certain, but they're certainly not doing it based on any privileged information as the shorting has been going on for 2 months yet we had a director buying only a few weeks ago. Of course, a director could not buy if they were in receipt of privileged information on a likely approval and equally could not sell if they knew a CRL was on the cards, but they could choose 'not to buy' if they had information of a likely CRL
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Verharven
Posted on: Sep 21 2019, 05:02 AM


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Yes, that's my understanding as Vyleesi had a PDUFA date that fell on a Sunday, but the outcome was released to the market COB on the Friday before.
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Verharven
Posted on: Sep 19 2019, 10:06 AM


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168k shares traded on the opening bell 😮
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Verharven
Posted on: Sep 18 2019, 04:50 PM


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One word: arbitrage. Companies trading on multiple exchanges will always be close in price (so long as sufficient trading volume) as any drift from this opens up an arbitrage opportunity which markets players will seize on for a quick profit which restores the market balance.
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Verharven
Posted on: Sep 18 2019, 09:44 AM


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Hoping that the worm has finally turned


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Verharven
Posted on: Sep 13 2019, 03:41 PM


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It's shorting driven by technical analysis mostly in my eyes. TA though isn't going to tell you if the FDA decision is going to be yay or nay as the shorting has been happening since early July so there is really little chance of somehow 'inside' knowledge of a pre-ordained negative decision. I think the shorters have gay abandon for the PDUFA date which consensus here seems to be much better odds than 50:50 for approval so is playing with fire and I for one will rejoice in the pain inflicted on the shorters if they are still open if a positive decision comes in.
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Verharven
Posted on: Sep 12 2019, 04:34 PM


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Shorters only 'wreck' a company if they cause a pile on in selling from actual holders of the stock and I don't see much evidence of that happening. Every short MUST be closed out by buying back in again so there is a lot of buying demand now in the wings so everything that happens in between is mostly about the fundamentals.
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Verharven
Posted on: Sep 10 2019, 11:47 AM


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Here are the 12 month short and SP graphs for CUV and NEA - try to spot the difference.


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Verharven
Posted on: Sep 4 2019, 08:18 AM


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Where has all the buy and sell volume gone???


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Verharven
Posted on: Aug 28 2019, 02:52 PM


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First daily fall in net shorts since July 12 (not counting the clearly data blip error from Aug 13 of a near 2.5 percentage point fall). The rise in shorts over this time has been far steeper than the decline in the share price.
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Verharven
Posted on: Aug 28 2019, 01:25 PM


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So they had to reissue the financial report because they forgot to add the independent auditor's declaration. They're also yet to pick up that they stuffed up something as simple as giving a record and ex date for the dividend. Record date is given as Thursday 5 Sep with the ex date of 17 Sep! To start with, ex dates are one trading day BEFORE a record date so no idea how on earth they came up with this. Two very embarrassing amateur errors.
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Verharven
Posted on: Aug 23 2019, 11:58 AM


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Last year, preliminary financial results and dividend announced Wednesday, August 29. The year before it was Wednesday, August 30 so expecting this mid next week. I'm going for a $0.05 divvy
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Verharven
Posted on: Aug 20 2019, 03:08 PM


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As for shorts...next minute, we're back up at 5.46%!! And noted NEA also jumped as well to be just above where it was two trading days before so it's technical games being played.
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Verharven
Posted on: Aug 19 2019, 01:39 PM


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Showing how meaningless really daily gross shorts data is, open short positions just fell from 5.22% to 2.76% as of August 13 when gross shorts for that day were 78k.
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Verharven
Posted on: Aug 14 2019, 01:10 PM


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Yes, shorts just ticked over the 5% mark today (as of August 8 - 5.01%) and there hasn't been a day decline in short positions since July 12 when they were at 2%. The SP weathered the first 2-3 weeks of it, but not so the last 1-2 weeks.
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Verharven
Posted on: Aug 14 2019, 08:59 AM


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And we're set for another day with a spike in the SP on open (currently predicted at $28.49 with excess buy volume) likely only to be ground down over the course of the day by shorters. This game of musical chairs can only be played for so long and the end of the song is approaching.
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Verharven
Posted on: Aug 13 2019, 05:23 AM


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An update from MinusSinus

https://seekingalpha.com/article/4284940-ta...ation?dr=1#alt2


Clinuvel Has More Aces Up Their Sleeves - A Monte Carlo Valuation

Summary

Clinuvel Pharmaceuticals is waiting to get an FDA response for the first treatment of EPP patients in the US by Oct. 2019.

The stock has risen significantly from the anemic trading during the last decade, but is the stock price still covered by the underlying business value?

A Monte Carlo analysis over the three applications of EPP, VP, and Vitiligo shows a median fair value of 32.5 USD/share, with the 10-90% confidence interval being 20-62 USD/share.
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Verharven
Posted on: Aug 13 2019, 05:19 AM


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The Homm effect? Germany went a little crazy last night with high volume and close of EUR 17.30 (AUD 28.73) even peaking at EUR 17.79 (AUD 29.54)
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Verharven
Posted on: Aug 8 2019, 03:18 PM


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Just adding to the recent posts - I topped up on Tuesday and so too have a few family members who have been in it for some time. Think it's a great price now to buy-in for where we are at - global markets will do what global markets do.
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Verharven
Posted on: Aug 5 2019, 03:57 PM


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If it makes things any better, the biotech peers to CUV of PME and NAN are down a similar amount today
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Verharven
Posted on: Aug 5 2019, 01:41 PM


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Something I've posted before is the graph below taken from the thesis here It's 35-45 days pre-decision date that the SP ramp-up begins so hopefully CUV will follow this trend. If you were a shorter you should be aware of this timeline to be looking at closing out by then unless you were uber-confident of a negative decision, but if so you'd be nuts to short now - just do it before the decision when the SP should be at its potential highest and then reap the reward of the SP crash soon after.


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Verharven
Posted on: Jul 31 2019, 09:22 AM


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Quarterly out: $13.0 M in receipts and $54M in the bank smile.gif


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Attached File  Announcements.pdf ( 450.98K ) Number of downloads: 140

 
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Verharven
Posted on: Jul 12 2019, 12:20 PM


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I've posted before that CUV and NEA have been tracking each other quite closely the last few months (apart from when NEA got the ASX200 inclusion bump earlier for its out-of-cycle addition) and today NEA is down over 7% so seems technical trading with the new ASX200 entrants rather than any fundamentals.
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Verharven
Posted on: Jul 10 2019, 01:15 PM


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ASX200 stocks sorted by 1-year price change. Things aren't too bad are they.
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Verharven
Posted on: Jun 29 2019, 09:24 AM


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No, Vyleesi is given subcutaneously just like botox which can also be given intramuscularly with similar efficacy. Scenesse is given as an implant subcutaneously though is a bit more of an involved procedure than a simple injection
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Verharven
Posted on: Jun 26 2019, 02:31 PM


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More like snorting it tongue.gif
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Verharven
Posted on: Jun 26 2019, 06:23 AM


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Just something I've noticed recently and the 6-month graph below confirms it, is that CUV and Nearmap have had a very similar story over the last 12 months. They're both the best 1-year performing stocks on the ASX200 - up over 200% and apart from the SP bump that NEA got earlier from being added to the ASX200 on April 15 from MYO being removed, they track closely. Note the downturn they've both experienced in recent days so could indicate TA traders are having a say in both.
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Verharven
Posted on: Jun 25 2019, 05:46 AM


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I think he was more coming from the reality that an injection mode of delivery will be much less popular/saleable than a pill so this will affect take up. I agree with his views on efficacy now I've looked more closely at the trial results plus there is the established competitor on the market too which is in pill form.

Agree with other comments that we're probably in for a period of SP flat line/dipping for a while as we bob along without many big price drivers and the SP seems reasonably priced now based on future EU earnings and a bit of FDA speculation. But it is great to know that there has been all this short action absorbed into the SP so that will be a nice buffer if the SP drops further and the shorts close out.
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Verharven
Posted on: Jun 24 2019, 01:02 PM


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Just looked at Shortman: there were 615k gross shorts on Friday so that explains a lot of the extra volume that went through. Shorters gonna short - worked out so well for them over the last few months tongue.gif
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Verharven
Posted on: Jun 22 2019, 06:48 PM


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Posts: 807

Top marks to the SPDR ASX200 ETF fund - already updated their holdings. They picked up 96,817 shares. Where the hell did all the other shares go as the SPDR fund is one of the big ETFs???

https://www.spdrs.com.au/etf/fund/spdr-sp-a...0-fund-STW.html
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Verharven
Posted on: Jun 22 2019, 10:46 AM


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When Viagra was launched in the US market, half a million scripts were written in the first month. When Addyi was launched in October 2015, it was only prescribed to a little over 200 patients in the first month. By February 2016, the total number of scripts written was less than 4,000. Can't find current data, but clearly, a blockbuster this drug ain't nor will Vyleesi be either so PTN investors seem to have got a little bit 'over excited' (see what I did there) by approval or have an eye to future indications.
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Verharven
Posted on: Jun 22 2019, 10:14 AM


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Hmm, perhaps, but there is already a drug on the market to treat pre-menopausal HSDD - Addyi (flibanserin). Addyi increases the number of satisfying sexual events per month by about one half over placebo. Compare that to Vyleesi which did not change the number of satisfying sexual events compared to placebo. Addyi also seems to have less side-effects and contraindications for its use.
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Verharven
Posted on: Jun 22 2019, 08:55 AM


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Makes CUV's marketing a walk in the park. An extremely well-defined, small and accessible population just about all of who will know about the only effective treatment so far for EPP. PTN are going to have to invest big in marketing to get the word out just to tip enough doctors over that they'll prescribe it.
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Verharven
Posted on: Jun 22 2019, 08:27 AM


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These are far from impressive results - a very small increase in self-reported sexual desire in ONLY 25% of women compared to 17% that also saw a benefit in the placebo group?! And look at the decrease in distress scores - hardly any difference in the drug vs placebo in % of women that saw a drop?! This is great though if this is the benchmark of efficacy that the FDA uses. They only would have got these as significant differences because of the large sample size so while statistically significant, the overall benefit across a population is small.

"The effectiveness and safety of Vyleesi were studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD. Most patients used Vyleesi two or three times per month and no more than once a week. In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo. Additionally, about 35% of the patients treated with Vyleesi had a decrease of one or more in their distress score "(scored on a range of zero to four, with higher scores indicating greater distress from low sexual desire) compared to about 31% of those who took placebo."
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Verharven
Posted on: Jun 22 2019, 07:49 AM


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I wouldn't describe it a 'useless' drug. Hypoactive sexual desire in women can cause personal distress and relationship problems so can affect quality of life. Kinda like the long-term psychological and quality of life problems that arise from not being able to go out and enjoy the world during daylight hours...
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Verharven
Posted on: Jun 22 2019, 06:15 AM


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So feel for the UK EPP sufferers for how this has dragged on - all starting with NICE 'misclassifying' the approval track to start wtih and not giving it HST status off the bat - so much time wasted from that. I can't fault CUV though for how aggressively they've fought this every step of the way. At least a negative decision is already priced into the SP.
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Verharven
Posted on: Jun 22 2019, 06:03 AM


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Posts: 807

So with the ASX200 speculation behind us and with a PDUFA date still over 3 months away, what's there to fill in the void?

1. The next quarterly end of Jully (I am projecting ~$15M in receipts)
2. Getting overdue for news on the NICE re-assessment decision
3. Dividend. Sure, it was only $0.02 ps (~$1M) last year, but they've set the precedent and cash has only grown in the bank since then. Maybe they'll go crazy and double it to $0.04

Anything else? I can't see NASDAQ happening until after a FDA decision (that is positive) as they won't be running new trials to pursue new indications there unless they know the drug is looked upon favourably so hard to sell the story to the US market without that.
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Verharven
Posted on: Jun 21 2019, 04:11 PM


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Close @ $38.55 with a volume of 1.86M so that was 1.4M after the close.
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Verharven
Posted on: Jun 21 2019, 04:04 PM


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1.7M on the buy side, 1.7M on the sell side. Indicative price of $38.79
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Verharven
Posted on: Jun 21 2019, 04:01 PM


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Posts: 807

And here come the ETFs...



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Verharven
Posted on: Jun 21 2019, 03:59 PM


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1 minute to close and the buy volume just doubled to 272k
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Verharven
Posted on: Jun 21 2019, 02:23 PM


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Bit of a mid-arvo frenzy happening - real on market buying, no more bots. What will 4pm bring...


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Verharven
Posted on: Jun 21 2019, 11:51 AM


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Clinuvel moves digs to Level 11, 535 Bourke St (only 650 metres by foot from their prior Queen St offices). Hopefully, because they needed more space... Nicer part of the world though.

If you look here on Google Stree View, you can see PW's moto out the front decked in CUV colours,

https://www.google.com/maps/place/535+Bourk...3;4d144.9580248


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Verharven
Posted on: Jun 20 2019, 09:32 AM


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Because the clinical trials need to 'prove' it helps lower the risk of skin cancer would take years, if not decades to do. And as for a 'sunscreen' replacement, that isn't going to fly at this stage for something that requires a surgical intervention to administer. This is all future gazing when topicals make it into development.
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Verharven
Posted on: Jun 20 2019, 08:01 AM


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Astaxanthin does have an effect on reducing UV damage so that a person taking it can tolerate a higher 'dose' of sun before a sunburn occurs, but certainly not in the same league as sunscreen. Following is one of the first clinical trials in this area, and you can find anecdotes online of fair skin people taking it reporting that they can be out in the sun longer without getting burnt. Pretty confident it isn't much of a benefit for EPP else the community would have been on to it years ago seeing as a bottle costs a few dollars and is OTC. Fun fact: flamingos are born white, but turn pink as they develop from eating algae that make astaxanthin. Another fun fact: salmon is naturally white, but becomes pink/red from all the krill it eats which, as you may guess, is full of astaxanthin.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6073124/

The Protective Role of Astaxanthin for UV-Induced Skin Deterioration in Healthy People—A Randomized, Double-Blind, Placebo-Controlled Trial

Skin is a major safeguard tissue in humans. Because biological barrier function is deteriorated by several kinds of stresses including exposure to ultra-violet (UV) rays, the protection and treatment of skin conditions by dietary supplements are important. We therefore evaluated the effects of dietary supplementation with an algal food-derived antioxidant, astaxanthin, on UV-induced skin deterioration. Twenty-three healthy Japanese participants were recruited to a 10-week double-blind placebo-controlled study. They were assigned to the astaxanthin group supplemented with a capsule containing 4 mg of astaxanthin or the placebo group. To assess the protective role of astaxanthin for UV-induced skin deterioration, we determined the minimal erythema dose (MED) and analyzed UV-induced changes of moisture and transepidermal water loss (TEWL) at baseline and after 9 weeks of supplementation. Subjective skin conditions were assessed by the visual analog scale. The astaxanthin group showed increased MED compared with placebo. In addition, the astaxanthin group had a reduced loss of skin moisture in the irradiated area compared with placebo. Subjective skin conditions for “improvement of rough skin” and “texture” in non-irradiated areas were significantly improved by astaxanthin. Astaxanthin seems protective against UV-induced skin deterioration and helps maintain healthy skin in healthy people.
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Verharven
Posted on: Jun 19 2019, 02:53 PM


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Posts: 807

Spot on. The biggest SP killer I've seen in recent times is CUV's newsletters - if you haven't got something clear and unambiguous to say, then don't say anything at all. I pray that Stan and PW STFU until October 6.
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Verharven
Posted on: Jun 19 2019, 02:13 PM


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Posts: 807

It's good volume, but my screen shows me it is 'only' double the average last 3-month volume so has been building for some time.
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Verharven
Posted on: Jun 18 2019, 02:12 PM


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So the index ETFs stay true to their mission and buy and sell at the rebalance and play it by the numbers, so unless a large holder/insto steps in as an opportunity to off-load, where are these needed shares going to come from on Friday? Hint: not mine. Could be the greenest of green days on Friday....
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Verharven
Posted on: Jun 18 2019, 09:38 AM


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Here you go. I like the look of the sell depth


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Verharven
Posted on: Jun 18 2019, 08:28 AM


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Gang, James no longer thinks CUV is expensive!

https://www.fool.com.au/2019/06/18/the-clin...6-in-12-months/

The Clinuvel Pharmaceuticals share price is up 236% in 12 months

The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price was an impressive performer on Monday.

The biopharmaceutical company’s shares raced to an all-time high of $36.98 before finishing the day 7% higher at $36.49.

When Clinuvel’s shares hit the $36.98 mark, it meant they had gained a staggering 236% since this time last year.

Why is the Clinuvel Pharmaceuticals share price on fire?
This latest gain appears to have been driven by the company’s recent inclusion in the benchmark S&P/ASX 200 index at the June quarterly rebalance.

It was added to the index after meeting the ranking requirements for the S&P/ASX 200 based on its float-adjusted market capitalisation and median liquidity over the past six months.

But the key driver of its share price gain over the last 12 months has been the success of its SCENESSE product.

SCENESSE has been developed as a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria (EPP).

A few years ago management made the strategic decision to self-distribute SCENESSE. Together with its decision to oversee and manage the supply chain and build a network of accredited centres of porphyria expertise, this has underpinned the company’s impressive sales growth.

During the March quarter the company reported cash receipts of $5.9 million, which was an increase of 126% on the previous quarter and 70% on the prior corresponding period.

And this does not include sales in the United States as SCENESSE is not yet available in this key market. But if all goes to plan, the company could be generating sales in the United States in the near future.

The US FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 6 to provide it with time for a full review of the submission of the SCENESSE scientific dossier. If the regulatory body gives SCENESSE the tick of approval, it could lead to a solid increase in sales.

Time will tell whether it is the next CSL Limited (ASX: CSL), but Clinuvel certainly is worth watching closely.
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Verharven
Posted on: Jun 16 2019, 11:58 AM


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That $0.50 was really just about short-term for knowns based on EU role out and not even considering potential other markets post FDA so certainly on the metrics, CUV is not an 'expensive' stock and perhaps could even be considered a little undervalued, but I'll take $34 any day of the week from the base we've come from :-)
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Verharven
Posted on: Jun 16 2019, 10:55 AM


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Posts: 807

Good question. From MorningStar data from my trading platform, for 2020 forward P/E you are looking at:

PME: 139
NAN: 107

There is no data for CUV for 2019 or 2020, so really comes down to what EPS you want to plug in. Current P/E of 127 is based on an EPS of $0.267 though this a little out of date it seems as I've just realised, as should be an EPS of 0.332 to give a P/E of 102 according to data on the ASX and another site and using that data, gives a current P/E for NAN of 138 and for PME 146. So based on current P/E, CUV is well below its peers.

Not unreasonable to see an EPS at perhaps $0.50 in the near future so you have a forward P/E of 68 so makes CUV look even better compared to its peers on their forward P/Es for potential price growth.
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Verharven
Posted on: Jun 16 2019, 08:32 AM


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Just looked at a couple of biotech peers to CUV as far as MC range and also are making money.

PME has a MC of $2.4B and a P/E of 152
NAN has a MC of $1.5B and a P/E of 116

Compare that to CUV with its MC of $1.7B and P/E of 127

If you look at the most mature of biotechs going around such as CSL, RMD and COH, they have P/Es in the rage of 35-45 so for any long-term conservative price guesstimation, this would be the appropriate P/E to use.

So the summary is that the P/E for CUV is quite reasonable atm especially considering the profit growth still happening from Europe as EPS will bump up a lot this year and the rest of the price comes from anticipating a positive FDA decision.
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Verharven
Posted on: Jun 15 2019, 08:06 AM


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One more ASX200 ETF - it's German based and pretty small, but every bit helps

Xtrackers S&P ASX 200 UCITS ETF

https://www.bloomberg.com/quote/XAUS:GR
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Verharven
Posted on: Jun 14 2019, 04:12 PM


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Posts: 807

ASX200 means a bump from ETF index fund buying 'locking away' the shares. Also opens up CUV to funds that have rules that only allow them to buy ASX200 companies and then the signal that is sent to the wider community that this is a serious company now. CUV now sits in the top 150 companies on the ASX.
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Verharven
Posted on: Jun 14 2019, 01:33 PM


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Posts: 807

The one to watch is SPDR S&P/ASX 200 Fund as has a MC similar to the Vanguard ASX300 fund which has 371k CUV shares. The iShares ETF has a MC about one-third of the others. The BetaShares Australian 200 ETF is the minow of the group and has 12k shares.
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Verharven
Posted on: Jun 14 2019, 01:11 PM


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Posts: 807

iShares Core S&P/ASX 200 ETF

SPDR S&P/ASX 200 Fund

CUV is already in the portfolio of the BetaShares A200 as uses a slightly different methodology index to the ASX200

Then there is BetaShares FTSE RAFI Australia 200 ETF which some outlets say tracks the ASX200, but is based on a top 200 index based on economic footprint, not MC. CUV is not currently one of their holdings.
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Verharven
Posted on: Jun 14 2019, 10:12 AM


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It's looking just fine


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Verharven
Posted on: Jun 14 2019, 09:53 AM


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So right now, CUV sits at position 151 on the ASX200 index and second best 1-year performer only just behind Nearmap. How's the calcs looking for the ASX100 waz? lmaosmiley.gif
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Verharven
Posted on: Jun 14 2019, 08:01 AM


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Posts: 807

ASX200 rebalance announcement out and it's CUV, SSM and ASB in and SWM, SYR and NVT out.

Props to waz


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Verharven
Posted on: Jun 14 2019, 07:45 AM


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It's 2018 :-)
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Verharven
Posted on: Jun 11 2019, 10:17 AM


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Book looking very good

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Verharven
Posted on: Jun 10 2019, 09:21 AM


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Heads up for our overseas friends, it's the Queen's Birthday public holiday here in Oz so no ASX trading. Long may her majesty reign and rule over her colony.
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Verharven
Posted on: Jun 8 2019, 06:30 AM


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Posts: 807

Nice to see the US leading the way overnight up 2.25% and closing at USD 22.75 (AUD 32.49) and hitting an intra-day high of USD 23.07 (32.95). Maybe the US roadshow is attracting a bit more interest?
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Verharven
Posted on: Jun 6 2019, 06:52 PM


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Someone wrote a while back that they can't be considered as too much of their stock is tightly held by directors etc that's why MC calculation for the index inclusion is based on the free-float sahres, not the total number of shares
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Verharven
Posted on: Jun 6 2019, 04:00 PM


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Friday week the 14th
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Verharven
Posted on: Jun 4 2019, 03:23 PM


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From the FDA: Please Accelerate Approval of the Life Changing Afamelanotide for EPP Facebook group https://www.facebook.com/pg/AccelerateAppro...lanotide/posts/

"Not happy about this. The FDA has pushed their decision date to October. Everyone needs to contact their state representatives to help us and apply pressure. This is just a delay tactic by the FDA!"
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Verharven
Posted on: Jun 4 2019, 08:26 AM


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Seriously quality post you put up - props for doing all that research - feeling a bit better about things today!
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Verharven
Posted on: Jun 3 2019, 02:59 PM


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Was expecting a SP drop below $30 today so held up well and there are valid reasons this time for such a large fall though in the scheme of the rise over the last few weeks, the SP looks great! I'm very bullish on ASX200 inclusion so that should give a good buying support base plus those mass of shorts will have to come back eventually and probably a few more added today.
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Verharven
Posted on: Jun 3 2019, 01:16 PM


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So Shortman has now updated to include all that huge volume in the after close trade from Tuesday of last week and open shorts jumped by 401k to 1.03M open positions.
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Verharven
Posted on: Jun 3 2019, 09:10 AM


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PDUFA date now extended to October 6
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Attached File  Announcements.pdf ( 162.4K ) Number of downloads: 316

 
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Verharven
Posted on: Jun 1 2019, 07:21 PM


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I'm Iggy and so is my wife!
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Verharven
Posted on: Jun 1 2019, 05:34 PM


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Yes, what this indicates is what I have had a gut feel about in that negative and positive Phase III trial results can 'leak' out into the market, while a FDA decision outcome is a pretty tight ship so no noticeable difference in the price run-up for those that end up getting a positive vs negative decision. Though the data from this study was a fairly small sample size and was just oncology drugs.
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Verharven
Posted on: May 30 2019, 05:29 PM


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Yes, that is the other strong possibility so just as good an outcome as the sell has already occured so will support the SP post outcome whatever the decision when closing out. And thanks for raising the CGT reason as I was trying to understand why you would go to the hassle and extra expense to short when you can just sell some of your own holding now for pretty much the same outcome.
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Verharven
Posted on: May 30 2019, 02:46 PM


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More unwinding of short positions as I was expecting with total open positions now down to 547k as of last Friday so negatively correlating with the SP rise into the second part of last week as shorters took their medicine and headed for the exit. Probably another fall tomorrow in open shorts to take into account Monday's further SP rise and then on this coming Monday afternoon, will see where it bounces to take into account all the after close gross short action from Tuesday. Seriously, if you're shorting now this late in the day with the lead into a FDA decision run up and ASX200 inclusion price drivers, then you're betting the house on a negative FDA decision rather than CUV 'looks overbought'.
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Verharven
Posted on: May 28 2019, 08:39 PM


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From poster andyat over at Hotcopper

"CUV was added the MSCI Aus small cap index at close today. Not too many of the big boys are benchmarked to that, only one" I know of is Vanguards Small Cap ETF. At $250M, for each % in the benchmark they'll need close to 100k shares. If there are one or two other players using the same BM then that would explain the volume today."
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Verharven
Posted on: May 28 2019, 04:19 PM


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Posts: 807

Only ever traded over 1M shares in a day twice before. Once was 6.1M in 2008 which was a fund getting out in one transfer. The other was in 2003 which was just over 1M, but of course, that was pre 10:1 consolidation days so really is 100k. As for liquidity, sadly won't do a lot as it is based on median liquidity over 6 months so would be 'better' to have say 10 days of 100k rather than all in one go. Who cares though, we'll be in the ASX200 sooner rather than later.
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Verharven
Posted on: May 28 2019, 04:11 PM


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Close at $35.16 with 833k shares going through at the close out.
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Verharven
Posted on: May 28 2019, 04:02 PM


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Just hit 4pm and went from about 115k on the buy side and 30k on the sell side to instantly 595k on the buy side and 550k on the sell side.

Edit: 1M now on the buy side and 638k on the sell with an indicative price of $36 - see where this goes at the 4:10pm close out...
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Verharven
Posted on: May 28 2019, 11:16 AM


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Sunscreen??? Come on waz, this is CUV - it's a complimentary implant for all SHers so we can all sport the PW glow 😂
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Verharven
Posted on: May 28 2019, 10:08 AM


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Posts: 807

It's a feeding frenzy and shorters are the main course. Still over 700k of them open as of last Tuesday.


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Verharven
Posted on: May 25 2019, 05:30 AM


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You can probably take all price mentions here to be AUD considering this is an Australian-based discussion board discussing an Australian-based company and where the German and US bourses follow the ASX price leads. Agree though, the falling Aussie dollar has not been kind to our overseas investor friends!
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Verharven
Posted on: May 24 2019, 08:05 PM


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Hey gang, James is back and guess what he's saying about CUV? His last sentence implies though that he thought they weren't overvalued in the past (like when he started calling them expensive when they were $24 in mid Feb) 😂

https://www.fool.com.au/2019/05/24/is-it-to...ing-asx-shares/


Is it too late to buy Telstra and these high-flying ASX shares?


The CLINUVEL Pharmaceuticals Limited (ASX: CUV) share price reached an all-time high of $32.22 on Thursday. The biopharmaceutical company’s shares have rallied significantly higher over the last 12 months thanks to the success of its SCENESSE product. SCENESSE is a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria (EPP). In the March quarter the company reported cash receipts of $5.9 million, up 126% on the previous quarter and 70% on the prior corresponding period. This strong growth could be given a big boost in the near term if the U.S. FDA approves it for sale in the United States at its upcoming Priority Review. Whilst I think CLINUVEL is an exciting company, I feel its valuation is a little stretched now.
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Verharven
Posted on: May 24 2019, 12:58 PM


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$49 approved and $22 CRL
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Verharven
Posted on: May 24 2019, 10:14 AM


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Posts: 807

Mark Knopfler's pickless style is speaking to me and saying Money for Nothing atm
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Verharven
Posted on: May 24 2019, 10:05 AM


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Here you go. $32.86 open
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Verharven
Posted on: May 23 2019, 02:17 PM


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Not when there is lots of buyer demand (impending FDA decision and ASX200 inclusion being key), some of which could be previous shorts closing out to stop the bleeding of losses as we keep hitting ATHs.
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Verharven
Posted on: May 17 2019, 03:39 PM


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Posts: 807

James, James, James - a not-so-subtle backhander to say that CUV is still too expensive which he started on about when they were under $24 with the only analysis he has ever provided to support this view is how much % they've risen. The Fool.


https://www.fool.com.au/2019/05/17/insiders...ese-asx-shares/

Insiders have been buying Macquarie and these ASX shares

Clinuvel Pharmaceuticals Limited (ASX: CUV)

A change of director’s interest notice reveals that non-executive director, Dr Karen Agersborg, has bought a number of this biopharmaceutical company’s American depositary receipts (ADRs) this month. According to the notice, Dr Agersborg picked up 1,200 of the company’s ADRs for an average of US$16.7804 per ADR. This equates to a total consideration of just over US$20,000 and brings her holding up to a total of 2,900 ordinary shares and 1,200 ADRs. Clinuvel’s shares have rallied 74% higher since the start of the year, but this director appears to still see value in them.
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Verharven
Posted on: May 17 2019, 01:17 PM


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I see that FDA link pop up quite a bit when I do time-restricted CUV searches so have learnt to not read too much into it now
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Verharven
Posted on: May 17 2019, 10:07 AM


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For those on 20-minute delay, spoiler alert


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Verharven
Posted on: May 17 2019, 05:48 AM


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Big volume in CLVLY overnight of 119k shares which in the history of its trading, has only been surpassed 5 times and all of those occasions were in Oct/Nov 2014 at EMA approval time. But if you factor in SP, then by value it was the biggest trading day in its history by almost double the previous highest mark. Both German and US prices point to AUD 30.50.
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Verharven
Posted on: May 16 2019, 05:51 PM


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Agree Frogster. Comparing companies based on how many shares are on offer is a meaningless metric - it is like comparing companies purely based on SP and saying that a $100 company is somehow different (more expensive) from a $2 company. Need to look at both shares issued and SP together which is of course what market cap captures. Avita could do a 100:1 share consolidation to reduce the shares issued to 18.6 million, but of course the SP would increase 100 times to $49 - end result is no change to any of the fundamentals or the worth of the holdings anyone has.

Sorry you missed out on the SP watching fun today Frogster!
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Verharven
Posted on: May 16 2019, 02:46 PM


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A special milestone


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Verharven
Posted on: May 15 2019, 02:29 PM


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And noted that James no longer states that CUV is too expensive and here we have the SP up 6% as I write this. And 800,000 open short positions still come back into the market and just about all of them are well out of the money. Add in a good chance of ASX200 inclusion and the spike that will give from the ETF buying etc plus of course the little matter of the sub 60 days countdown to FDA decision and that potential run-up and it is a good time be a CUV holder.
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Verharven
Posted on: May 15 2019, 09:39 AM


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Clicking the link, I get a message that need to read it on a device that has Apple News?
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Verharven
Posted on: May 14 2019, 02:40 PM


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Yes, Nearmap was added about a month ago as an out of cycle inclusion when MYOB was removed due to a takeover. At the rebalance time in March, CUV and NEA were neck and neck for being next in line for inclusion. It will come down to liquidity for CUV as the final hurdle to clear.
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Verharven
Posted on: May 9 2019, 09:22 AM


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Shaping up to be a healthy start


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Verharven
Posted on: May 8 2019, 08:48 AM


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Bank of New York Mellon now listed as a substantial shareholder with 5.2M shares so any clues what that this relates to in this now needing to be notified to the market? The announcement makes for great reading as page 6 onwards is about the original relationship between BNY as a ADR holder and Epitan way back in 2004 laugh.gif


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Attached File  Announcements.pdf ( 1.81MB ) Number of downloads: 123

 
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Verharven
Posted on: May 7 2019, 04:25 PM


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On April 17 the SP closed at $24.40 and there were 419k short positions. Since then, the SP has dipped down into the low $20s and is now moving strongly back above that $24.40 mark but the number of short positions sits at almost double at 794k (as of last Wednesday) - that's a lot of shorts under water.
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Verharven
Posted on: May 5 2019, 01:41 PM


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Here's what happens when you don't take FDA's concern's about manufacturing seriously

https://endpts.com/fda-rejects-acacias-lead...acturing-issue/

FDA rejects Acacia’s lead drug — again — due to the same manufacturing issue

May 3, 2019

Acacia Pharma did well on the R&D front — by 2017, it had conducted four positive pivotal clinical trials for its lead drug, Barhemsys. Later that year, it submitted an FDA application to market the drug for rescue treatment of patients who develop postoperative nausea & vomiting (PONV), despite having been given prior antiemetic prophylaxis — only to receive a rejection in October 2018.

The US agency made its decision based on a pre-approval inspection of a facility run by the contract manufacturer of the drug’s main ingredient — amisulpride — and not on clinical or non-clinical data in the application, assured Acacia in a press release, adding that the FDA had asked for no extra studies or data analyses related to the treatment.

With renewed enthusiasm later that month, Acacia said its contract manufacturer had agreed to “institute a corrective and preventive action plan that will rectify the deficiency identified as quickly as possible. We continue to plan for a launch in the first half of 2019,” Acacia chief Julian Gilbert said in a statement.

Acacia then resubmitted its marketing application in December, indicating that the FDA’s concerns outlined in the complete response letter had been resolved. But on Friday, the company received another rejection, with the FDA flagging the same concerns.

“We are on track to complete the qualification of an alternative supplier of amisulpride and plan to engage with FDA as soon as possible to determine the most rapid route to obtaining approval,” Gilbert said in a statement on Friday.

Barhemsys is designed to help the 30-40% of surgical patients who suffer from PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients.

Cambridge, UK-based Acacia Pharma, which also has US operations in Indianapolis, was founded in 2007. It has another amisulpride-based drug — APD403 — in mid-stage development for chemotherapy induced nausea & vomiting.
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Verharven
Posted on: May 4 2019, 06:44 PM


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Just getting a handle on pure probabilities for the chance of approval for any drug once it gets to NDA submission. Data here from 2006-2015 covering 1,050 submissions puts the success rate at 85.3% taking into account re-submissions. Puts into context the ridiculous binary probablity PW used in the newsletter of 50-50 as that's like saying my chance of winning lotto tonight is 50-50 in that I either win or I don't when the true probability is several million to 1 against.

https://www.bio.org/sites/default/files/Cli...lion%202016.pdf
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Verharven
Posted on: May 3 2019, 07:39 AM


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Just hit 'Esc' or any other way to stop a page from fully loading and paywall problem solved
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Verharven
Posted on: May 2 2019, 06:10 AM


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Insto and fund ownership updated to April 30 (click on the ownership tab) https://www.morningstar.com/stocks/pinx/clvlf/quote.html

Fidelity is now out! Vanguard picked up all of their shares as they added ~948k over their various funds in the month of April (click on the 'Funds' and 'Institutions' tabs to see this)
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Verharven
Posted on: May 1 2019, 03:58 PM


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Posts: 807

Gross shorts of 140k yesterday with the SP holiding up very well to it which is good to see. Total shorts now at 624k as of Wednesday last week and will increase based on the gross positions of the last few trading days. I'd say the SP has absorbed this very well and I welcome the shorters money when they need to buy back in to close out.
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Verharven
Posted on: Apr 30 2019, 09:38 AM


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Quarterly out. $5.9M in receipts - up 70% from the corresponding March quarter last year. $45M cash in the bank
Attached File(s)
Attached File  Announcements.pdf ( 215.62K ) Number of downloads: 78

 
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Verharven
Posted on: Apr 29 2019, 12:56 PM


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A nice article on FDA approval times http://www.pharmexec.com/how-fast-are-fda-fast-lanes for drugs given the 'fast lane' designation under 4 different types of programs so includes priority review which is what Scenesse has. Point of note is that even though the PDUFA date is given as 8 months from the submission date for a PR (so 6 months once the day 74 letter has been generated which we got in Jan) this isn't set in stone and the second graph (Figure 2) I've copied below is the one of interest showing the median time of approval for Priority Review (PR - in green) is about 240 days (8 months) which is bang on the expected timeframe, but there is a range of about 90 days to 620 days though maybe a trend for this getting into a narrower band for all approvals with each year especially now in 2018/2019 with the push for even faster approvals..



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Verharven
Posted on: Apr 20 2019, 08:31 AM


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A few clues to how a stock price can fare in the run-up to a FDA decision taken from a Master of Economics thesis in 2012/13 https://lib.ugent.be/fulltxt/RUG01/002/062/...013_0001_AC.pdf

The price starts to run up above the relevant biotech index about 60 days prior by about 20% and then the binary yes/no decision can boost it further by an additional 20 percentage points if positive. These are averages of course so a small biotech with a single drug could be expected to have wider fluctuations compared to an established pharma with a suite of drugs already in their portfolio. Note the uptick in the SP in the days prior to a positive decision and a drop over the same period when the decision turns out to be negative - coincidence I'm sure...
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Verharven
Posted on: Apr 18 2019, 09:47 AM


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Keep in mind that the float-adjusted MC and liquidity was good enough for adding to the Chi-x 200 Index shortly after the ASX200 miss though this was based on 3 months data c.f. ASX200 which used 6-month so more favourable for CUV for the recent trading. Plus not long back either CUV was added to the Solactive Top 200 index which triggered the purchase of 12.5k shares by the BetaShares Australian 200 ETF which tracks this index so MC and liquidity met their mark and used 6 months data so CUV likely only just missed out for the ASX200 from the poor data in late August/early September with a SP at $12-$14 dragging things down.
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Verharven
Posted on: Apr 16 2019, 04:24 PM


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That news of Nearmap inclusion in the ASX200 sent the SP up almost 5% today on a volume almost 3-times recent trading data
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Verharven
Posted on: Apr 14 2019, 01:02 PM


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CBA is around $70 and CSL at $200 so a long way to go before share splits would be needed as the market has no issues with those nominal prices
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Verharven
Posted on: Apr 11 2019, 11:34 AM


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James is back and still thinks CUV is too expensive!

https://www.fool.com.au/2019/04/11/why-clin...e-in-12-months/

Why CLINUVEL and these ASX shares have doubled in value in 12 months

Over the last 12 months the All Ordinaries Index has carved out a gain of 6.3% excluding dividends.

Whilst this is a positive gain, it pales in comparison to some of the gains that have been made on the index.

Three shares that have doubled in value over the period are listed below. Here’s why they have rocketed higher:

The CLINUVEL Pharmaceuticals Limited (ASX: CUV) share price has rocketed 155% higher since this time last year. The main catalyst for this has been the impressive sales growth of the company’s SCENESSE product and upcoming regulatory reviews. SCENESSE has been developed as a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria (EPP). Sales have been growing strongly in FY 2019 and could be given a major boost in the coming months if the US Food and Drug Administration gives it the tick of approval at its Priority Review meeting in July. I like CLINUVEL but I feel its shares are looking expensive at current levels.
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Verharven
Posted on: Apr 11 2019, 11:33 AM


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Posts: 807

James is back and still thinks CUV is too expensive!

https://www.fool.com.au/2019/04/11/why-clin...e-in-12-months/

Why CLINUVEL and these ASX shares have doubled in value in 12 months

Over the last 12 months the All Ordinaries Index has carved out a gain of 6.3% excluding dividends.

Whilst this is a positive gain, it pales in comparison to some of the gains that have been made on the index.

Three shares that have doubled in value over the period are listed below. Here’s why they have rocketed higher:

The CLINUVEL Pharmaceuticals Limited (ASX: CUV) share price has rocketed 155% higher since this time last year. The main catalyst for this has been the impressive sales growth of the company’s SCENESSE product and upcoming regulatory reviews. SCENESSE has been developed as a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria (EPP). Sales have been growing strongly in FY 2019 and could be given a major boost in the coming months if the US Food and Drug Administration gives it the tick of approval at its Priority Review meeting in July. I like CLINUVEL but I feel its shares are looking expensive at current levels.
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Verharven
Posted on: Apr 1 2019, 02:58 PM


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An update on Fidelity's holding - now at 946k shares as of March 31 - down 778k over the month of March. Interesting that three Vanguard funds picked up 400k shares between them over the same period

Click on the 'Ownership' tab in the link here for deets
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Verharven
Posted on: Mar 26 2019, 02:47 PM


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Nice. CUV have just been added to the holding for the BetaShares Australia 200 ETF for the largest 200 companies listed on the ASX. Just 9,743 shares in the fund but what is most important is that CUV met the criteria for the index methodology used to assess the 200 largest companies

https://www.betashares.com.au/fund/australia-200-etf/

The index is the Solactive Australia 200 Index and looking at their metholody, a similar approach to using free-float MC and ranking better than 175 for inclusion and worse than 225 for exclusion plus uses 6 months data as well so similar to ASX200. Can't understand how their liquidity calculation works to make any meaningful comparison to the market, but if it is good enough for this index then am sure CUV is travelling well for ASX200 inclusion.
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Verharven
Posted on: Mar 25 2019, 12:53 PM


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https://au.finance.yahoo.com/news/bell-pott...-004458687.html

The News Corp media is that morning reporting that sell-side broker Bell Potter has upgraded ASX stock Clinuvel Pharmaceuticals (ASX: CUV) to a “buy” rating.

Clinuvel is a global biopharmaceutical business headquartered in Melbourne that sells treatments for a range of genetic and skin disorders with its main product named SCENESEE that is used to treat a rare genetic skin disorder called erythropoietic protoporphyria (EPP).

Its shares are now up more than 150% over the past year after it reported a profit of $4.076 million on revenue of $8.98 million for the six month period ending December 31 2018.

The revenue and profit were up 27% and 189% respectively over the prior corresponding half year period. It also held no debt and $42.3 million cash on hand to fund its growth strategies.

Its SCENESEE product is approved and sold in the EU and the company has applied to the US healthcare regulator the FDA for permission to sell the product to certain classes of patients, with a decision from the regulator due in July 2019.

Management appear confident the product will be approved, with it reporting that approval would potentially double its EPP product’s addressable market.

However, investors should remember that there’s no guarantees for new product approval from the FDA, while anticipation of the product being approved may already be factored into the fast-rising share price.

Another ASX-listed biopharmaceutical company to have a product application delayed (at a minimum) by the FDA recently is Starpharma Limited (ASX: SPL), despite its management team telling investors they were confident their product application would be approved.

Clinuvel has a market value of $1.24 billion today based on a share price of $25.33, which suggests investors are confident it will get the US regulatory approval required. If not the stock could come under selling pressure.
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Verharven
Posted on: Mar 25 2019, 07:48 AM


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The mid-cycle review timing does appear to come earlier than expected which aligns with an expedited review for a decision a month earlier than the PDUFA date as the meeting should be March based on a 6 month review time from the 60-day submission date (submission in early November) so the actual review time is 8 months from submission - the FDA uses confusing language when they talk about 6 months review for PR as the review has already started by the time the applicant gets the Day 74 letter. The median time for a PR from data I posted previously is 8 months and I first took it as they usually went over time as should be 6 months, but actually is bang on the planned 8 months from submission and is what the PDUFA date is based on.
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Verharven
Posted on: Mar 24 2019, 08:30 AM


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Nice little infographic timeline for the NDA review process taken from 21st Century Review Process Desk Reference Guide https://www.fda.gov/downloads/aboutfda/cent...s/ucm218757.pdf

Text in red is for a PR so we've already ticked past the mid-cycle meeting which is flagged as month 3 and happened in Feb. Looking at this and with the live possibility of an expedited review on the table then a decision in June could well be a possibility.
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Verharven
Posted on: Mar 22 2019, 07:55 PM


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Just read that the Day 74 letter also states the date the NDA was submitted, which is also the date the review clock begins so what the submitted day was officially listed as would have been at some date later 2018 so yes, mid-cycle in Feb seems the appropriate timing.
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Verharven
Posted on: Mar 22 2019, 07:19 PM


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I thought the Day 74 letter flags when the formal review starts (when the NDA has been accepted) so this was Jan 9 and as stated in the document that Day 74 letter also serves to notify of preliminary plans to hold an Advisory Committee meeting which we know CUV were told they didn't require. The mid-cycle meeting though has been heald as that was stated clearly in the newsletter so a possibility that the FDA is really pushing this along?
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Verharven
Posted on: Mar 22 2019, 05:45 PM


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Some in-depth thinking there. I would agree that if all the long hours, frequent FDA questions and tight turnaround times was indeed bad news as indicated issues, why the hell would CUV profile it as the opening of the newsletter? I actually thought it was a bit bizarre that any of that would be written in a newsletter (look at us, we're working really hard in a job we're paid to do), but PW thought it important enough to acknowledge his staff. I thought the following from the document you linked to was noteworthy as if the expedited review was flagged, it would have occurred when they got notified of the PR in the Day 74 letter

3. Day 74 Letter: FDA will follow existing procedures regarding identification and communication of filing review issues in the “Day 74 letter.” For applications subject to the Program, the timeline for this communication will be within 74 calendar days from the date of FDA receipt of the original submission. The planned review timeline included in the Day 74 letter for applications in the Program will include the planned date for the internal mid-cycle review meeting. The letter will also include preliminary plans on whether to hold an Advisory Committee (AC) meeting to discuss the application. If applicable, the Day 74 letter will serve as notification to the applicant that the review division intends to conduct an expedited review.
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Verharven
Posted on: Mar 21 2019, 11:03 AM


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117,985 shares cross-traded @ $27.46 at 12:02pm. Let's hope it doesn't trigger the fun and games that started yesterday not long after a similar transaction.
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Verharven
Posted on: Mar 21 2019, 10:36 AM


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Gross shorts only 10k yesterday so if the T+4 data shows a big decline in open short positions I would warrant yesterday was more about driving down the SP to close out shorts.
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Verharven
Posted on: Mar 21 2019, 09:05 AM


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Here you go - for some reason open was delayed by about a minute today which had me thinking of a TH too

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Verharven
Posted on: Mar 21 2019, 05:12 AM


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That was my thinking about yesterday - shorters were gettting a hiding as ATHs were continually being hit and was threatening to break through resistance selling at $30 into blue sky. So yesterday may have been an effort to induce some panic selling so positions could be closed out. Will wait with interest for 11:30 am to arrive today so we can see the gross shorts from yesterday and in four trading days time for the total short positions to be known for yesterday.
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Verharven
Posted on: Mar 20 2019, 05:58 PM


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This just in: James still thinks CUV is too expensive

https://www.fool.com.au/2019/03/20/why-the-...26-lower-today/

Why the Clinuvel Pharmaceuticals share price plunged 26% lower today

It certainly has been a volatile day of trade for the Clinuvel Pharmaceuticals Limited (ASX: CUV) share price.

The biopharmaceutical company’s shares fell as much as 26% to $22.24 at one stage today, before recovering a good portion of this decline.

At the time of writing the Clinuvel share price is down 9.5% to $27.17.

Why did the Clinuvel Pharmaceuticals share price crash lower?
Although Clinuvel released its latest newsletter this morning, I don’t believe this was the catalyst for the selling. Having read through the release, everything appears to be going to plan for the company focused on developing treatments for severe skin disorders.

Looking through the course of trades on Wednesday reveals that the share price decline was triggered by some rampant selling just before lunch.

A single trade of 51,540 shares for $1.5 million started a wave of selling that continued for around half an hour and drove its share price 26% lower.

Considering the Clinuvel share price was up 187% over the last 12 months and trading at an all-time high yesterday, I wouldn’t be surprised if one of its shareholders has decided to take a bit of profit off the table.

In addition to this, the selling could also have come from inside the company. Last week CEO Dr Philippe Wolgen exercised 716,642 performance rights at no cost. Two other executives exercised 25,000 performance rights as well.

Perhaps these directors have decided to offload a portion now whilst the share price is high in order to cover their tax obligations further down the line.

If this proves to be the case, the company will notify the market in the coming days with a change of director’s interest notice.

Should you buy the dip?
Whilst I think Clinuvel Pharmaceuticals is an exciting company and has a lot of potential thanks to its SCENSSE product, which is a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria, I wouldn’t be a buyer at this level.

At the current price I feel that its shares are expensive and do not offer a sufficient risk/reward. For now, I would stick with CSL Limited (ASX: CSL) and maybe even Mayne Pharma Group Ltd (ASX: MYX).
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Verharven
Posted on: Mar 20 2019, 04:19 PM


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We opened the year at a very healthy $18.10 with the uncertainty of even if we had a green light by the FDA for final acceptance of the NDA and start of the review with a RTF a possibility. And here we are 2.5 months later 45% above that with the FDA priority review passing the 2-month mark.
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Verharven
Posted on: Mar 19 2019, 07:55 PM


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Okay, my eyesight isn't what it should be as read it as 'forum', when it says 'form' - my bad
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Verharven
Posted on: Mar 19 2019, 05:11 PM


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Well, well, seems CUV is planning an investor forum on their website - password protected at the moment. I tried the password 'epitan' but no dice

https://www.clinuvel.com/testing-new-investor-form
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Verharven
Posted on: Mar 19 2019, 01:45 PM


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They're all open-market sell orders that have been sitting there for some time so I think more like people liking a round number to cash in on some hefty profits.
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Verharven
Posted on: Mar 19 2019, 01:30 PM


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Here you go

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Verharven
Posted on: Mar 19 2019, 08:24 AM


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Across the German exchanges, UR9 closed at EUR 18.77 ($29.97) and peaked at EUR 18.90. Reflected in the indicative open for the ASX now at $29.98
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Verharven
Posted on: Mar 19 2019, 05:04 AM


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I wouldn't put too much significance on the July 8 date as this is more an aspirational target for the FDA. From data I posted previously, based on the last 3 years, the median approval time for a priority review was 8 months and ranged from just over 90 days to almost 2 years so I would treat the 8 April as the starting point where news could arrive 'any day'. Considering the FDA has had many years to take a look at Scennesse under the rolling review and it has EMA approval I am mildly optimistic that it could be a shorter review time.
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Verharven
Posted on: Mar 18 2019, 03:12 PM


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Posts: 807

No after-market close shenanigans today, but still, 32k shares going through at 4:10 pm to finish the day on a volume of 173k is not bad at all.

Fun fact: the number of days prior to 2019 where daily traded value exceeded $2M was 17 and all but 3 of those were in 2018 (2 were in 2014 when EMA approval came through and the other an aberration from a bulk share transfer in 2008 of $17M for the day). Number of days we've gone past $2M this year so far is....20
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Verharven
Posted on: Mar 15 2019, 03:11 PM


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And close at $28.81 with over 400k shares going through after the bell.
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Verharven
Posted on: Mar 15 2019, 03:03 PM


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As soon as we hit 4pm, over 800k shares have come onto the sell side and over 300k on the buy side - who knows what this will close at!???
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Verharven
Posted on: Mar 15 2019, 02:57 PM


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Posts: 807

The Fool continuing on with their CUV promo. I noted that James also called them as expensive in mid Feb when they were at $24.60.....


https://www.fool.com.au/2019/03/15/why-the-...just-12-months/

Why the Clinuvel share price has tripled in value in just 12 months

The best performer on the All Ordinaries over the last 12 months has been the Clinuvel Pharmaceuticals Limited (ASX: CUV) share price.

On Thursday the shares of biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders hit a new all-time high of $28.90.

At that point the Clinuvel share price had climbed a remarkable 217% since this time last year.

Why has the Clinuvel share price more than tripled in value in 12 months?
Investors have been fighting to get hold of Clinuvel’s shares due to the success and strong growth potential of its lead compound, SCENESSE.

SCENESSE is a first-line pharmaceutical product aimed at treating patients with the rare genetic disorder erythropoietic protoporphyria (EPP).

A few years ago the company made the strategic decision to self-distribute SCENESSE. This, and its decision to oversee and manage the supply chain and to build a network of accredited centres of porphyria expertise, has underpinned the company’s growth and helped it deliver an impressive half year result last month.

For the six months ended December 31, the company posted an interim net profit of $4.1 million, up 189% on the prior corresponding period.

The good news is that there’s still a long runway for growth ahead for the product. Notably in the U.S. market where the US Food and Drug Administration has granted a Priority Review for SCENESSE on July 8.

If it can satisfy the FDA’s requirements the drug could be on sale in the United States in the near future and provide an added boost to its sales.

As will the launch of other topical melanocortins for a range of diseases and conditions in the future. Management advised that its teams are currently building the framework to commercial success by addressing each part of the supply chain of this novel category.

Should you invest?
I think Clinuvel is a quality company and has a bright future ahead of it, but its shares do look a little expensive now after this stellar run. As a result, I would suggest investors take a look at industry peers CSL Limited (ASX: CSL) and Mayne Pharma Group Ltd (ASX: MYX).
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Verharven
Posted on: Mar 15 2019, 01:09 PM


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Posts: 807

Shortman updated to now include Monday and open shorts went from 165k on the Friday to 253k on the Monday. Ouch.
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Verharven
Posted on: Mar 15 2019, 11:50 AM


Group: Member
Posts: 807

Just a little bit of resistance at $30 and then we're off again


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Verharven
Posted on: Mar 14 2019, 12:29 PM


Group: Member
Posts: 807

Totally - we were all nuts to be buying and a look at my purchase history shows that I even loaded up over 35k shares in the sub $2 range at one stage when it was under EMA review - not sure if I was full of confidence or deluded at that stage, but know how I'm feeling about it now....
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Verharven
Posted on: Mar 14 2019, 12:22 PM


Group: Member
Posts: 807

Shortman just updated to the total number of open short positions to now include Friday of last week that saw the SP fall from the ASX200 non-inclusion. The total short positions actually declined slightly from 173k on the Thursday to 165k on the Friday. It's why the gross shorts that are updated daily aren't always the best guide as there can be opening and closing of positions occurring at the same time so the 4-trading-day lag data is better to look at. All academic really as we keep hitting ATHs - no one is making money from shorting.
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Verharven
Posted on: Mar 14 2019, 11:32 AM


Group: Member
Posts: 807

As a long-term holder (first purchase back in 2003 in the Wayne Millen and Epitan days!) it's still taking some adjusting to this 'new normal' as CUV powers on day after day to ATHs with hardly blinking through short selling and even 2.5% dilution yesterday from 1.2M shares being issued through the rights. I feel those shorting really don't understand the full history of this company when they just see a parabolic SP rise that is 'due for a correction' when the shares are so tightly held by many LTers who are here at a minimum until the FDA decision - a retrace of a few dollars from shorting gets hardly a second thought when you've been through the dark days of sub $2 and even went as low $0.915 in Dec 2013 with the real possibility of being wiped out from an adverse EMA decision.
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Verharven
Posted on: Mar 13 2019, 09:47 AM


Group: Member
Posts: 807

On the plus side, the MC of CUV gets a boost by virtue of going from 47.86 M shares to now 48.96 M lmaosmiley.gif
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Verharven
Posted on: Mar 13 2019, 05:17 AM


Group: Member
Posts: 807

That is a nice find and does have implications at least for the case for adding to the ASX 200 index in June as the methodology has some parallels to the S&P methodology. It is based on the free-float MC like the ASX 200, but crucially it uses the last 3 months trading data rather than 6 months for the ASX 200. The inclusion ranking is better than 180 places and for exclusion worse than 220 so similar to ASX 200 too. For liquidity, they use a calculation called 'velocity' (see page 6) so this seems different to the ASX 200, but am sure it will be close to the same sort of end result as the ASX 200 uses and if liquidity for the last 3 months is good enough for Chi-x then that period and the next 3 months (if we keep going as we are) should be good enough for the ASX 200.


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Attached File  CXA_200_Index_Methodology_V1.0_CXA_Final.pdf ( 337.52K ) Number of downloads: 45

 
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Verharven
Posted on: Mar 12 2019, 09:20 AM


Group: Member
Posts: 807

And we're just touching $28 again now... can't be good for those who shorted $2.2M in stock last Friday....
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Verharven
Posted on: Mar 8 2019, 08:30 AM


Group: Member
Posts: 807

Ah, you are correct as I forgot that an appreciation in the SP will be reflected in the change to the weighting of the shares held. So new shares would only be needed with fresh money flowing into the fund and this would apply across the board.
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Verharven
Posted on: Mar 8 2019, 07:02 AM


Group: Member
Posts: 807

Rebalancing announcement out - missed out this time. PNI (MC $950M) and HUB ($790M) added and IFN ($511M) and AHG ($673M) removed

Attached File(s)
Attached File  885758_2019.03.08_quarta_200.pdf ( 77.86K ) Number of downloads: 206

 
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Verharven
Posted on: Mar 8 2019, 06:39 AM


Group: Member
Posts: 807

Yes, that April 11 date is just their next regular meeting of the standing committee as they last met on 12 Feb to discuss three different drugs and agenda then mentioned the next meeting for March 14 https:// 11www.nice.org.uk/event/hstec-february-2019
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