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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


Attached File(s)
Attached File  Announcements.pdf ( 450.98K ) Number of downloads: 138

 
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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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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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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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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


Attached File(s)
Attached File  Announcements.pdf ( 109.27K ) Number of downloads: 63

 
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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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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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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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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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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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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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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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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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Attached File  943758_2019.06.14_quarta_200.pdf ( 184.43K ) Number of downloads: 172

 
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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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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: 314

 
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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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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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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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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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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: 117

 
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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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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
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Attached File  Announcements.pdf ( 215.62K ) Number of downloads: 77

 
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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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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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Posts: 743

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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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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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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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


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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


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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


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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


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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


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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


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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.


Attached File(s)
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


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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


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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


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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: 198

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


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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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Verharven
Posted on: Mar 8 2019, 06:05 AM


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And as we wait for the rebalance announcement today, here's an indication of the effect of the ASX200 ETFs buying into CUV could have if it's added using market cap of the funds as a proxy for how many shares they would buy.

Vanguard ASX300 fund (VAS) has a MC of $3.4B and 345k CUV shares (as of Jan 31 - holding will have increased significantly over Feb because of SP rise)

For the 3 ASX200 ETFs, their MCs are:

iShares Core S&P/ASX 200 ETF (IOZ): $1.14B
SPDR S&P/ASX 200 Fund (STW): $3.7B
BetaShares FTSE RAFI Australia 200 ETF (QOZ): $235M

So that's just on $5B combined c.f. $3.4B for VAS so would expect demand for at least 500k shares which based on low liquidity will only drive the SP higher, further increasing the need for the ETFs to buy more shares...

And while not an ASX200 index ETF, there is also the BetaShares Australia 200 ETF which invests in the largest 200 companies on the ASX based on MC and has a fund MC of $415M though CUV is yet to show up as one of their holdings https://www.betashares.com.au/fund/australia-200-etf/
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Verharven
Posted on: Mar 6 2019, 07:54 PM


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A nice article on FDA approval times 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 6 months 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), with 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. Now I know CUV set the record for the longest ever EMA approval time so really not keen to get that record with the FDA as well, but seeing this is now a drug that has EMA approval and has an exemplary safety record nice to think that there is a possibility that approval could even come early.

http://www.pharmexec.com/how-fast-are-fda-fast-lanes
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Verharven
Posted on: Mar 6 2019, 04:18 PM


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They are just bot generated pieces of trash reports - the Internet is full of them when you search for a stock. They are there to get you sign up to their stock report newsletters
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Verharven
Posted on: Mar 6 2019, 12:54 PM


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There are quite a few here with large stakes in CUV, but have been involved for many years and have a good knowledge of all the ins and outs so question to you, if you don't mind me asking, is what you made you invest such a large relative sum if you don't know much about the company and the stock market in general? It's a genuine question - just interested in what made you buy in?
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Verharven
Posted on: Mar 6 2019, 12:37 PM


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Unless CUV were planning on shutting up shop in Oz and moving to the States, then the ASX will be the primary exchange for well into the future so no share transfer would occur. I think the chat you are referring to is what would happen to current US holders of the ADRs if NASDAQ listing happened.
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Verharven
Posted on: Mar 6 2019, 12:11 PM


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NASDAQ listing would just be another exchange you can buy and sell on - no difference to the current German listing and current lower tier ADR listing in the US. Of course, if there is high demand and liquidity on one exchange, then that can pull the other exchanges along with it and the NASDAQ could offer that. If you're in Oz, then buying in Oz is the easiest way to go.
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Verharven
Posted on: Mar 6 2019, 05:23 AM


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AFR reading hack - hit 'escape' before the page fully loads and voila!

In other news, on high volume, Germany closed at EUR 17.35 ($27.68) and the US at USD 19.40 (AUD 27.37)
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Verharven
Posted on: Mar 4 2019, 03:18 PM


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Great info waz. Below is a 1-year comparison of CUV vs NEA with price normalised at the starting point so very clear parallels with the1-year gain identical, but for the last 6 months CUV is a clear leader for a higher average MC over that time.
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Verharven
Posted on: Mar 2 2019, 07:40 AM


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Clinuvel - WTF???


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Verharven
Posted on: Feb 28 2019, 11:41 AM


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Good times


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Verharven
Posted on: Feb 28 2019, 04:37 AM


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Small correction in that data on gross shorts is for trading on Tuesday - it is updated about 11 am each day for the preceding day's trade. The real data of interest is the total number of short positions and that lags by 4 trading days and so far shows no sign of much change with 153k open positions as of Thursday of last week. No matter how you slice and dice it though, if the SP is hitting ATHs on high volume then shorters are in pain.
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Verharven
Posted on: Feb 27 2019, 01:59 PM


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If you listen carefully, you can hear the cry of the shorters being squeezed

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Verharven
Posted on: Feb 27 2019, 12:00 PM


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Just for those without access to the depth. A bit of sell volume at the 'magical' $25 mark, but otherwise looking good for higher prices still, and again today plenty of volume going through on both exchanges with the ASX at 54k and Chi-X at 36k midway through the trading day.
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Verharven
Posted on: Feb 26 2019, 12:25 PM


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Friday was the last day of data used in the rebalance calculation so price and volume action from yesterday onwards won't count, but great to see the volume up today with 75k of the 110k on the ASX a crosstrade. Chi-x currently showing 38k volume so far today
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Verharven
Posted on: Feb 22 2019, 12:22 PM


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Interesting: Shortman has just updated to include the data for Monday which was the high volume big price jump day and the total number of short positions actually increased slightly on that day from 133k on the Friday to 147k on Monday. That's good news to see short positions increase in the face of a rising SP as that's buy volume that still has to come back onto the market.


https://www.shortman.com.au/stock?q=cuv
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Verharven
Posted on: Feb 20 2019, 08:34 AM


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So seems like there's a conga line of companies shafted by NICE with a rare disease drug
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Verharven
Posted on: Feb 18 2019, 06:43 PM


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Yeah, the Fool is full of those types of articles - they love a bit of click bait to funnel you into their subscriber 'hot tips', but hey, they have a decent audience so all good for the exposure.
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Verharven
Posted on: Feb 18 2019, 04:19 PM


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Some coverage from Motley Fool

https://www.fool.com.au/2019/02/18/the-clin...8-in-12-months/

The Clinuvel share price has hit an all-time high and is up 188% in 12 months

The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price continued its strong run on Monday and climbed 7% to a new all-time high of $24.60.

This means that Clinuvel, a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, has seen its share price rise a staggering 188% since this time last year.

Why is the Clinuvel share price on fire?
The main catalyst for this gain has been the impressive sales growth of its SCENESSE product over the last 12 months.

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

The product has been a huge success and has significant growth opportunities ahead, notably in the United States where the US Food and Drug Administration has granted a Priority Review for SCENESSE on July 8.

This means that if it can satisfy the FDA’s requirements the drug could be on sale in the United States in the near future.

Is SCENESSE a good product?
It appears to be held in high esteem by physicians. According to the company, as of June 2018, 98.5% of the European EPP patients who had received treatment during the previous two years were continuing to receive SCENESSE in the third annual cycle.

Management believes this is significant as the company does not actively promote the drug treatment but enables clinical demand and purchase orders to occur as is.

It explained that this commercial approach reflects its belief in an open system where patients and physicians can decide together whether a treatment should be received and prescribed without the pharmaceutical company intervening.

Should you invest?
Whilst I’m a big fan of Clinuvel and its management team, I’m not a huge fan of its share price right now after this stellar run.

In light of this, I see far more value in healthcare sector peers Cochlear Limited (ASX: COH) and CSL Limited (ASX: CSL) than Clinuvel. But I would certainly add its shares to your watchlist just in case a buying opportunity presents itself further down the line.
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Verharven
Posted on: Feb 18 2019, 11:50 AM


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Not good times for those with open short positions with the SP hitting ATHs on high volume....
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Verharven
Posted on: Feb 16 2019, 01:53 PM


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Could be a line-ball decision if it will be added in March because of the 6 months of data average, but if not, then as long as the SP holds the course as it has been doing for the last month then June would be looking very good and nice timing to get an inclusion SP bump 4 weeks before the FDA decision.
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Verharven
Posted on: Feb 16 2019, 01:38 PM


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Methodology below and on page 10 states that rebalancing announcements made on the second Friday of the month for March, June and December and first Friday of the month for September with trading in the new index to start after market close of the third Friday of the month. So the date given of March 15, 2019 on Market Index is actually when the rebalance happens - but announced a week prior.

Attached File(s)
Attached File  methodology_sp_asx_australian_indices.pdf ( 204.83K ) Number of downloads: 39

 
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Verharven
Posted on: Feb 16 2019, 07:01 AM


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So some upcoming dates of interest that could push along the SP

Friday, March 8: ASX200 rebalance announcement

Thursday, March 14: NICE Committee meeting to reconsider approval of Scenesse

April 30: Next quarterly figures (hopefully with the 'early payment' blip now washed through)
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Verharven
Posted on: Feb 15 2019, 05:19 PM


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Yes, it's a nice positive feedback loop so long as CUV keeps progressing over a decent time frame because it works just as well to the detriment in reverse!
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Verharven
Posted on: Feb 15 2019, 04:50 PM


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Vanguard updated their holdings for Jan 31 and shows a small increase in CUV held from 343k on Dec 31 to now 345k

https://www.vanguardinvestments.com.au/reta...8205/?portfolio
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Verharven
Posted on: Feb 14 2019, 11:50 AM


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Yes, for any serious investor the price is irrelevant as is just a number and going from $2 to $20 is no different from going from $20 to $200 though in Australia, there are plenty of 'mum and dad' investors who think stocks $20 and above are 'expensive' - would not believe how many times I've heard that! Thank god they don't live in America where $100+ is the accepted norm for many blue-chip stocks so hopefully, we're slowly moving to that way of thinking now with stocks like CBA around $70 and Macquarie, Cochlear, and CSL well into the $100 zone.
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Verharven
Posted on: Feb 14 2019, 09:53 AM


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I'd be supportive of it as ridiculous they ever did that 10:1 consolidation in the first place 10 years back
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Verharven
Posted on: Feb 14 2019, 09:25 AM


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Thought I'd post the current buy and sell depth for those that don't have full access
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Verharven
Posted on: Feb 13 2019, 02:03 PM


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Nice share! My first purchase was back in 2003 and have been back to the well many, many times since and still yet to sell a bean, but the time will come soon to let go of a few and a suitable 'toy' will be purchased!
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Verharven
Posted on: Feb 13 2019, 01:55 PM


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65k crossed trade @ $22.65 went through at 2:52pm - that helps with the daily volume for ASX200 calculations
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Verharven
Posted on: Feb 7 2019, 05:21 AM


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It is hard to speculate as here are the 3 ASX200 ETFs I'm aware of and their MC

BetaShares FTSE RAFI Australia 200 $224M
SPDR 200 Fund ETF Units $3.6B
iShares Core S&P/ASX 200 $1.04B

Now compare that to the Vanguard Australian Shares Index ETF which tracks the ASX300 which has a MC of $3.3B

So using MC as a rough guide to the relative spread of asset allocation in the fund which would be weighted by the MC of the individual companies, then that would mean a slightly higher level of demand for new shares for the ASX200 ETFs that come online compared to what Vanguard had when it joined the party. Can't recount Vanguard here as they've already got the CUV they need although they would have increased it slightly over Jan. So Vanguard have 343k shares (as of Dec 31) so easy to make the case for demand for at least 500k shares by the ASX200 ETFs and then there is increased exposure CUV would get by being added to the index plus any managed funds that choose to buy if they previously could only buy ASX200 companies.
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Verharven
Posted on: Feb 5 2019, 12:39 PM


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Or maybe our friends at FIL have left the building too?
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Verharven
Posted on: Feb 4 2019, 02:33 PM


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Regarding France, not sure if that has been shared here before from Nov 22, 2018

https://www.porphyrie.net/action-et-soutien/

From Google translate

"Erythropoietic protoporphyria: The Scenesse, a symptomatic treatment for Erythropoietic Protoporphyria, is still not available or reimbursed in France, but the Clinuvel company that markets it has finally started the reimbursement request to the health authorities. Our center gives all its support to advance in their efforts."

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Verharven
Posted on: Feb 3 2019, 06:52 PM


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The article is about CSL, but this quote certainly makes for nice reading for the company CUV is discussed with though based on market cap, outside of the 'Big 3' of CSL, Resmed and Cochlear, CUV is just about leading all other biotechs on the ASX

https://www.raskmedia.com.au/2019/01/29/pri...n-the-buy-zone/

"The CSL share price has been choppy but fallen slightly since hitting $227 in September. This is in line with similar declines for other top ASX healthcare companies, such as Clinuvel Pharmaceuticals Limited (ASX: CUV), Cochlear Limited (ASX: COH) and obstructive sleep apnea device maker Fisher & Paykel Healthcare Corp Ltd (ASX: FPH)."
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Verharven
Posted on: Jan 23 2019, 06:29 AM


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Great to see the PDUFA date as a big bold headline on the front page. Could do with a countdown clock though tbh biggrin.gif
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Verharven
Posted on: Jan 22 2019, 04:59 AM


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Rare to happen, but Germany was up overnight and leading the ASX at EUR 14.10 ($22.39)
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Verharven
Posted on: Jan 19 2019, 10:33 AM


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Some more coverage from the Motley Fool

https://www.fool.com.au/2019/01/18/why-the-...-the-past-year/

Why the Clinuvel share price is up 150% over the past year

The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price is now up around 150% over just the past year after rising from $8.89 this time last year to $22.13 today.

Clinuvel is a global biopharmaceutical company that develops treatment for severe and genetic skin disorders that has produced a drug named SCENESSE.

It reports the drug is on the verge of approval by the US drugs regulator the FDA. According to the company the FDA is set to communicate labelling and post marketing requirements for the drug in April 2019, with July 8 2019 a potential final review date that could see the drug approved assuming the FDA’s final hurdles for the drug are all cleared.

The SCENESSE drug has already been commercialised in Europe (approved in 2014) with total sales from customers hitting $10.75 million for the quarter ending September 30 2018 to produce an operating cash profit of $7.8 million. The pharmaceutical also had $44.4 million cash on hand at September quarter end to suggest its well funded for further research ahead.

Clinuvel now has a market value of more than $1 billion and the stock has been rising as it moves closer to FDA approval that could send its sales and profits soaring.

However, investors should remember FDA approval is never guaranteed, as pharmaceutical manufacturer Starpharma Ltd (ASX: SPL) recently showed, after its application for a clinical gel product approval was knocked back by the FDA.
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Verharven
Posted on: Jan 18 2019, 03:12 PM


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So something that hasn't really been discussed is this from the recent PDUFA announcement that "the FDA expects to communicate labelling and post-marketing communication labelling - if needed - by 8 April 2019". Does anyone know if this is a normal part of the leadup to PDUFA decisions as seems like a positive indication if it has been mentioned by the FDA and if not normally part of the process?
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Verharven
Posted on: Jan 18 2019, 12:50 PM


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Gross shorts for Tues, Wed and Thursday this week have just been 2-3k each day. Would be a brave person to go hard on shorting this now with the price stable and firm event milestones now for the next 6 months.
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Verharven
Posted on: Jan 18 2019, 08:03 AM


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You can use the auto-translate function for subtitles on YouTube, but jist is... CUV is the top his shortlist for 'buy now'. looks very cheap and still predicting a 10-times-bagger (as he has for years) from here with FDA approval, vitiligo and even skin cancer protection way in the future. Video has had 12k views already and only posted in the last day so a decent audience to hear it.
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Verharven
Posted on: Jan 17 2019, 09:24 AM


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Here you go (upload function now working)
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Verharven
Posted on: Jan 17 2019, 04:48 AM


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The Vanguard Australian Shares Index ETF (which tracks the ASX300) have updated their holdings for Dec 31 and shows a further increase in how much CUV they're holding. Now have 343k shares. Link here and you can see full details in the 'Export to spreadsheet' link near the end of the page.
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Verharven
Posted on: Jan 16 2019, 06:36 PM


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There have been 8 tweets in the last day - they've gone communication crazy
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Verharven
Posted on: Jan 16 2019, 01:25 PM


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Can't upload a screenshot of the market depth - seems there's an problem with the upload function here now

"Upload failed. Please ask the administrator to ensure the uploads directory is writeable"
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Verharven
Posted on: Jan 16 2019, 09:58 AM


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Yes, pricing will be the ultimate barrier to off-label cosmetic use. CUV has been like a dog with a bone regarding uniform pricing in Europe and can't see them moving much from that model for a while.
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Verharven
Posted on: Jan 15 2019, 04:49 PM


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    Good point about allowing for 'competition' for ASX200 inclusion. Though all a fun exercise in some ways as the inclusion boost whether it happens before or after approval (staying positive) will give the same longer term result from the share buying needed to be done by the ETFs
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    Verharven
    Posted on: Jan 15 2019, 04:33 PM


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    The ranking you linked to is based on all traded entities on the ASX - not all of these are included in indexes - ETFs that track indexes being a good example. As a guided you can view all ASX200 companies here https://www.marketindex.com.au/asx200 and then sort by MC so gives a guide to where CUV would slot in.
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    Verharven
    Posted on: Jan 15 2019, 01:31 PM


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    Yes, Phase 3 trials for EPP done in both Europe and USA. Without that USA trial, it would be a bit rocky to get FDA approval. Details here https://www.clinuvel.com/pharmaceuticals/sc...clinical-trials
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    Verharven
    Posted on: Jan 15 2019, 09:12 AM


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    Newsletter out here

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    Verharven
    Posted on: Jan 15 2019, 09:00 AM


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    Methodology for inclusion in the index is here

    Market cap and liquidity is based on the average of the last 6 months in the last Friday of the month in the month before rebalancing occurs. For MC, we're tracking along well to be under position 179 on the ASX200 (see page 12 of the document). Liquidity is a bit harder to determine as the formula for that is following. We clearly met the 30% minimum for inclusion in the ASX300 so will see if it is enough to get to 50% needed for the ASX200

    - S&P/ASX 200. Stocks require a minimum Relative Liquidity of 50% for inclusion in the S&P/ASX 200 and higher hierarchical indices.

    - S&P/ASX 300. Stocks require a minimum Relative Liquidity of 30% for inclusion in the S&P/ASX 300.

    Relative Liquidity is calculated as follows:

    Relative liquidity = Stock median liquidity (divided by) Market liquidity


    Stock Median Liquidity is the median daily value traded for each stock divided by the average float/index weight-adjusted market capitalization for the previous six months

    Market Liquidity is determined using the market capitalization weighted average of the stock median liquidities of the 500 companies in the All Ordinaries index.



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    Verharven
    Posted on: Jan 11 2019, 08:49 AM


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    Set for a good open

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    Verharven
    Posted on: Jan 10 2019, 06:59 PM


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    With all the uncertainty and speculation about what is happening with the FDA now firmly put to bed, what are we going to talk about for the next 6 months!? We have two quarterly reports, the NICE decision and maybe ASX200 inclusion that I can see coming up.
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    Verharven
    Posted on: Jan 10 2019, 02:09 PM


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    Coverage today from The Motley Fool
    https://www.fool.com.au/2019/01/10/why-the-...3-higher-today/

    Why the CLINUVEL Pharmaceuticals share price surged 13% higher today

    In morning trade the CLINUVEL Pharmaceuticals Limited (ASX: CUV) share price has pushed notably higher once again.

    At the time of writing the pharmaceutical company’s shares are up 13% to $21.70.

    This gain means that CLINUVEL’s shares are now up a remarkable 144% since this time last year.

    Why is the CLINUVEL share price storming higher today?

    Investors have been fighting to get hold of its shares this morning after the release of a positive announcement related to its SCENESSE product in the United States.

    SCENESSE is a drug used for the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP).

    According to the release, the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a Prescription Drug User Fee Act (PDUFA) date of July 8 2019.

    This essentially means that a Priority Review has been granted for SCENESSE on July 8, which could lead to the drug going on sale in the United States in the near future if it can satisfy its requirements.

    The company’s chief scientific officer, Dr Dennis Wright was pleased with the news.

    He said: “Acceptance of this NDA is the result of patience and hard work from the CLINUVEL team and medical community, bringing us a significant step closer to making SCENESSE available for US EPP patients,”

    He added: “We are pleased with the work of the FDA to date and, contrary to our own expectations, the agency has stated that it does not intend to hold an advisory committee meeting for further review of the product.”

    The company advised that it will now work towards a positive and landmark outcome for EPP patients on July 8.

    Should you invest?

    This is a very positive development for the company and I can’t say I’m surprised to see its shares take off today.

    The U.S. market represents a major market for SCENESSE and could generate significant revenue for the company.

    But with its valuation now ~$1 billion, I think CLINUVEL’s shares are fully valued and would suggest investors look elsewhere at the likes of CSL Limited (ASX: CSL) and Mayne Pharma Group Ltd (ASX: MYX).
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    Verharven
    Posted on: Jan 10 2019, 12:16 PM


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    Screenshot of PW's phone screensaver
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    Verharven
    Posted on: Jan 10 2019, 10:29 AM


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    Sucks to have been a shorter
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    Verharven
    Posted on: Jan 10 2019, 10:03 AM


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    And ASX200 addition this quarter
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    Verharven
    Posted on: Jan 8 2019, 03:15 PM


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    So something I've been doing for some years is every now and then I'll do a Google search for 'clinuvel' and restrict results to the last 24 hours or week to find any hidden nuggets as usually only a few pages of results. For the first time ever, one of the results was to the FDA press announcements page. Nothing about CUV there at the moment, but something trigged Google to output this result. Link here Maybe 'watch this space' as the day begins in the US for Jan 8?
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    Verharven
    Posted on: Jan 2 2019, 08:16 PM


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    https://www.statnews.com/2019/01/02/new-tre...gic-to-the-sun/


    Coming out of the shadows: A new treatment may help people who are ‘allergic’ to the sun

    By KAREN WEINTRAUB JANUARY 2, 2019

    Jennifer Beck had learned to cope with her disability. She’d park close to buildings to limit her sun exposure. She’d avoid bright patches of sunlight, even indoors. She’d wear long sleeves on hot summer days. “Yes, I know it’s hot,” she would respond to people who thought it was funny to comment.

    But then in April of 2017, for no apparent reason, her condition got much worse. Instead of just being sensitive to the sun, she began to react to all light. Even under a lightbulb, her skin would begin tingling. If she didn’t get away from it within a minute or two, the 50-year-old Beck would feel like someone was pouring boiling oil on her hands and face.

    With her condition, called erythropoietic porphyria, once the full-blown reaction to light starts, nothing treats the pain except time. And there is only one medication that can prevent the symptoms: a drug called afamelanotide, which is only available in Europe — and almost didn’t make it to market at all.

    That could change soon. An Australian-based drug maker hopes to secure priority review from the Food and Drug Administration for its treatment — the same one available in Europe — as early as next year.

    Approval would be a relief to the 600-some patients with the condition in the United States. But it would also serve as testament to how difficult it can be to get treatments for rare diseases onto the market.

    “The journey of not knowing what to do with this molecule took 20 years,” said Philippe Wolgen, the CEO of Clinuvel, the drug maker behind the treatment.

    Erythropoietic porphyria, or EPP, is caused by a genetic mutation that leads to a build-up of the chemical protoporphyrin in the skin, making it extremely light sensitive. Many patients report that if they ignore the initial tingling sensation and don’t get out of the light immediately, they feel intense pain, usually in their hands or face, which can last hours or days, in addition to redness and swelling. Some patients have worse symptoms than others, or report changes in symptoms, like Beck did.

    The treatment made by Clinuvel essentially works by increasing production of melanin, tanning the skin and protecting it from light, said Karl Anderson, an expert in porphyria-related diseases at the University of Texas Medical Branch at Galveston. Patients on the treatment can stand to be out in the sun, so they can tan a bit naturally, which provides more protection.

    The medication is delivered via an implant the size of a grain of rice — a method chosen to discouraging people from using it as a tanning product.

    Wolgen said that Chinuvel developed the molecule back in 1995, but wasn’t sure what indication to address with it. The company decided in 2005 to focus on EPP.

    One of the company’s challenges, though, was that no one had ever effectively treated light sensitivities like EPP before, so no one knew how to measure a drug’s effectiveness against it. Chinuvel had to devise a way to quantify the effects of light on biology.

    “Innovation is not enough. You need an entirely new environment,” Wolgen said.

    There was also the business challenge. Clinuvel took a major financial risk going after such a small market, Wolgen said. First, it wanted a guarantee that someone would pay for it. It took Clinuvel agreeing to subsidize nearly 80 percent of the drug’s cost for Switzerland and Italy to agree to make up the rest.

    For patients, the results have been “totally life-changing,” according to Desiree Lyon, executive director of the American Porphyria Foundation.

    “I would be the first one to go out in the street and yell” its praises, she said, complimenting Clinuvel for sticking with the drug.

    Lyon, who does not have EPP herself, said she’s talked with virtually every patient who has volunteered for clinical trials of the drug, and watched their lives dramatically improve on the drug, with no significant side effects. Patients were so eager to participate in research that 90 people signed onto one trial within a month, she said.

    The clinical trial was placebo-controlled, she said, but patients knew right away if they were getting the active drug. “I mean the change was immediate,” Lyon said. “When they got this real drug, they came from being shrouded everywhere they go…to being able to go to the beach, being able to go to work without being covered up.”

    But the drug is not cheap — it runs about $16,000 for an eight-week dose.

    The FDA granted the treatment an orphan drug designation in 2008, providing incentives for its development. A successful clinical trial was published in 2015 in The New England Journal of Medicine, and the drug has 10 years of safety data from its use in Europe.

    Still, it’s been tricky to design and conduct a study to show that symptoms are improved or prevented, said Anderson, the expert at the University of Texas.

    Clinuvel is awaiting validation of its new drug application, which the company hopes will come within the next few weeks. After validation, the drug will receive a Prescription Drug User Fee Act – or PDUFA – target date for FDA review. After that, if it receives priority review, the drug could be approved in 6-12 months; or 12-24 months for standard review.

    For now, because it hasn’t yet been approved yet in the U.S., any American who wants to use the drug has to pay their own way for the medication and travel costs to get it.

    When Beck’s condition worsened and her life closed in on her, she decided those costs were worthwhile.

    She and her husband took out a loan against their home in Cromwell, Conn., held fundraisers, and accepted donations. “It’s been a serious lesson in how to be thankful and how to receive graciously,” said Beck, an occupational therapist and mother of four. “When someone you know who’s 90 years old sends you a $5 bill, it breaks your heart.”

    The roundtrip airfare to Zurich, plus the therapy, ran the family $120,000 over the course of a year. But she can endure lightbulbs now, and her cover-up clothes sit folded in a dresser. Even the sun – which she avoided since before she could walk – is no challenge.

    She told her story by phone while sitting on the back deck she formerly used only at night.

    Beck recently experimented to see if she could make it 10 weeks between treatments, instead of the usual eight, but the gap left her very uncomfortable. She’s praying that her insurance, which did pick up the cost of her September dose, will continue paying. Even if the drug is approved in the United States it’s unclear whether how much insurance might cover.

    Regardless, Lyon, the foundation director, said she thinks it’s well past time for the drug to win FDA approval.

    “All the experts are very much behind this drug,” she said. “We need it desperately.”

    About Us
    STAT delivers fast, deep, and tough-minded journalism about life sciences and the fast-moving business of making medicines. We take you inside academic labs, biotech boardrooms, and political backrooms. We cast a critical eye on scientific discoveries, scrutinize corporate strategies, and chronicle roiling battles for talent, money, and market share. We examine controversies and puncture hype. With an award-winning newsroom, STAT gives you indispensable insights and exclusive stories on the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human health. These are the stories that matter to us all.
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    Verharven
    Posted on: Jan 2 2019, 07:03 AM


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    The video was from the same woman in the study where the photos were shown and it was 3 years after the study was done...
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    Verharven
    Posted on: Dec 31 2018, 01:12 PM


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    So we opened the year at $8.12 and closed at $18.10 – a gain of 123% for the year making us the third highest year gainer in the ASX300. To add to that, we’re now sitting at position 177 on the ASX200 if we were to be included ‘today’ which is in the zone for being considered for addition at the next quarterly rebalance.

    Inclusion in the ASX300 resulted in the Vanguard Australian Shares Index ETF that tracks this to take on 312k shares (as of Nov 30) so you can see the implications of being added to the ASX200 could be considering there are at least 4 ETFs that track it plus the additional factor that it would be a ‘green light’ for many funds to be allowed to buy CUV if they so choose if their rules precluded buying outside of the ASX200.

    Thank you to all the valuable information and insights posted by so many people here and looking forward to what 2019 brings for CUV
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    Verharven
    Posted on: Dec 31 2018, 12:45 PM


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    Thanks Waz and you'll see that Shortman has just updated to include the Dec 21 high volume trading so now at 179k shorts so increased by about 100k from the Dec 20 figure so was some covering occurring at the same time
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    Verharven
    Posted on: Dec 24 2018, 01:28 PM


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    Yes, I hope someone else with a bit more knowledge of how shorts are accounted for each trading day can enlighten on this as seems to me it could be short positions opened and closed repeatedly on the same day to rack up the gross shorts number?
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    Verharven
    Posted on: Dec 24 2018, 11:46 AM


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    Below taken from ShortMan - that was a lot of shorting that went through on Friday


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    Verharven
    Posted on: Dec 21 2018, 03:03 PM


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    Could be a good close out today as about 60k of buy orders came through in the mid $18.50s after 4pm close @ $18.28 so will see what eventuates at 4:10pm....

    Edit: And close @ $18.64 with 27k volume going through after the final bell. Nice little Santa rally
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    Verharven
    Posted on: Dec 19 2018, 10:55 AM


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    I liked the bit about 6 doses in 6 months
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