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A quick assessment (is at work) is that this is overall very good results.
It would of course have been nice to see statistically and not only clinically proven efficacy in the 100 mg arm instead of the 200 mg arm because that would make it easier to advance into maybe just one ph3 and not a Ph3A and Ph3B (or a Ph2B which might be necessary for definite dose finding before a Ph3). That would have been red meat for a potential partner and made a potential deal more valuable for CTIX. But as the CEO writes, the trial was not powered to do so.
However, all oral treatments for psoriasis that are underway seem to have problems and I definitely believe the results from this Prurisol trail is enough to secure some sort of partnership for the further advancement into 2 phase 3s and hopefully commercialization. I don't think we will see as monstrous up-fronts as in the recent AB$V / B or RD$ / $NPT deals. As Prurisol has always been the dark horse in the CTIX herd and given the fact that the company needs money to advance Kevetrin and Brillacidin I think the need for an early deal is there, and even though the value would be higher if CTIX advanced Prurisol into a Ph3 I think the company is better off striking a deal now and move on.
This is an old article that I recommend reading to get a very basic
insight to when to make a deal as a SME. It's from another time and economic environment but it's still good.
http://www.campbellalliance.com/articles/Les%20Nouvelles%20-%20Deal%20Timing%20-%20Sept%202010.pdf
In the recent years the EMA and the FDA have intensified their collaboration and they now have agents posted in both camps to strengthen that work. However, there is no guarantee that a drug approved by the EMA will be approved by the FDA. In clinical trials the CROs, sponsors and regulators also take into account the geographical, racial and cultural differences there might be. Even though Europe and the US seem very much alike, there might be differences in behavior, culture, food habits or climate (just to name a few) that can have a direct effect in the scientific evaluation of a drug. To us it seems hysteric but it all serves one purpose: To deliver safe drugs that work in the targeted population.
In Clinuvel's case, I admit that it seems that the FDA are dragging their feet. They could indeed have expedited the process and let Clinuvel submit an NDA, but then again, with the PASS protocol not yet in place in Europe, they can piggyback and just wait for that to be finished and perhaps use it directly in the US.
It's worst for the patients. I can't imagine how tough it must be to know there is a safe drug out there but you can't get it.
I believe the FDA will eventually approve Scenesse. But I don't think it will be this year.
My assumption is that Clinuvel will be allowed to submit an NDA later this year. They will get accelerated approval which means that they will rely on surrogate endpoints and thus perform a confirmatory phase 4 after the marketing of Scenesse in the US, which I believe will take off in March or April, 2017 at the earliest.
I also think they might want to distribute Scenesse for EPP through a BP partner who will also be on board for the further advancement of the Vitiligo program.
All speculation but we will know the first steps soon enough I think.
In the meantime, we should pray for compassionate use in the US for all the EPP patients there.
Thanks. I'm not a trader - only long. So trying not to get too caught up in the daily back and forth. This summer sure will be interesting. GL.
Haven't checked in for a while and kind of lost track of the timetables.
Would anyone have a few minutes to sum up when the different trial starts and other news is expected ?
Thanks a lot.
Yes. I don't pay much attention to the daily pps, though. It will go up and it will go down. But we will see higher highs and higher lows from here for sure.
Patients are desperately lining up to get the implant in Germany as well as in other WU countries and the US for that matter. Who wouldn't be with this horrible disease?
I expect at least 100 patients with implants in Germany EOY - perhaps double if they get the centers opened.
With 9 other EU countries coming online soon 500 patients EOY is not unrealistic. And 1000 patients by summer - end of the Australian financial year is not unrealistic either.
From the recent PR:
There is a lot I like about this company but their PR person is
definitely not part of that.
The decision to not make the following q/a public is bizarre.
It is a q/a conducted by the German
EPP society.
Good, clear language for once. And
good nuggets of information.
http://www.epp-deutschland.de/mediapool/21/211484/data/Antworten-Clinuvel-2016.pdf
Yes, nice price action after the IQWIG report. But as you say, we are still very much undervalued.
NASDAQ: I don't think Dr. Wolgen will take us to Nasdaq any day soon.
There is an added value of being on the ASX in a time where
we would be easy prey for shorters and other manipulators. This is not happening to the same extent on the ASX. I am also involved in other pharma companies here in the US and especially one of them, CT$X is getting killed by all sorts of manipulation. It's sad to watch. Clinuvel's succes is reliant on steady growth, trustworthy management and time. Right now we have it all but going to Nasdaq before the company has some fat on its bones would not be beneficial IMO. Also, I personally believe that stocks are in for a dramatic decline. When that happens, it will be good to be a small unknown, undervalued company sheltered on the ASX.
Give it time my friend. In a volatile World with crazy P/E ratios and bloated stock prices it's good to be one of the few companies that actually executes quietly.
CLINUVEL DUE DILIGENCE REPORT – UPDATED MAY 18th, 2016
WELCOME
Welcome to the Clinuvel iHub. There are some very active forums out there with valuable information about this company, but awarenes about both the stock and the products is very limited in the US so my goal is to provide a comprehensive walk through of the company, the products and the investment opportunity it represents so new investors have a place to start their DD.
In my view this is one of the most interesting and undervalued biotech companies right now. The fact that the lead drug obtained EMA approval late last year for the absolute light intollerance disorder, EPP and is now rolled out in Europe de-risks the stock. The company is also peforming mid to late stage trials in the depigmentation disorder, Vitiligo and resluts seem very good. Moreover, the company will seek label extensions for other uv related disorders once roll out of Scenesse for EPP is underway.
The clever investor with a little patience will see, that the historic approval of the World’s first tanning agent holds an extreme upside when the first medical indications are rolled out and broader use can commence. Eventually, Scenesse could be a general preventative for skin cancer due to the protective tan it provides and them the numbers get very big. But EPP alone will make the company very profitable very soon, and roll out in Europe is now a fact.
LATEST NEWS:
Price per implant:
Clinuvel gets favorable validation of the new asking price per implant from the German drug watch dog, IQWIG. According to the newly released report, IQWIG finds that $21.971 is a fair price for one Scenesse implant. This is major news, as it is now possible to roughly calculate the future revenue stream for EPP in Europe.
Link to the IQWIG report:
https://www.g-ba.de/downloads/92-975-1359/2016-05-10_Bewertung-Therapiekosten-Patientenzahlen-IQWiG_Afamelanotid.pdf
Furthermore, IQWIG estimates that there are 450-900 adult EPP patients in Germany. This is significantly more than most people thought, and I expect the picture to be the same throughout Europe which again will lead to higher than anticipated revenues from EPP.
EU countries coming online:
On May 17th Clinuvel announced that preparations for launch are now active in 9 EU countries and that more will follow in 2016. Germany is now implating in Dusseldorf and more porphyria centers will follow soon.
Link to the announcement:
http://www.clinuvel.com/index.php?option=com_k2&Itemid=8&id=528_db768a583c49d195c5bc87a1899dfb19&lang=en&task=download&view=item
BACKGROUND:
Clinuvel is an Australian biotech company with headquarters in Melbourne, Australia and an operating office in Baar, Switzerland. The company was formely know as EpiTan but changed it’s name to Clinuvel in 2006 following a change in management.
http://www.lifescientist.com.au/content/biotechnology/news/epitan-opts-for-name-change-854737925
EpiTan tried to promote EPT1647 (later known under the trade name, Scenesse) as a cosmetic drug which wasn’t very popular with the FDA or the EMA. No regulator wants to approve a drug solely for cosmetic use, and Epitan almost went bankrupt.
A new CEO was brought in, Philippe Wolgen, and under his guidance the company has performed er very successfull and well managed turnaround. Off label is now an absolute no-go if you ask the CEO and the strategy is to devellop Scenesse for patients with legit conditions. Last year this strategy resulted in a historic marketing approval of Scenesse following the longest review process in the EMA’s history. It too several years and heavy involvement by patients, patients advocates and scientists who spoke in favor of the drug in person in front of the CHMP – the council that desides whether a drug gets approval or not.
http://www.clinuvel.com/en/investors/news-publications/announcements/2014-announcements/clinuvel-invited-to-emas-chmp-plenary-session-for-an-oral-explanation-on-scenesse%C2%AE-maa
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002548/smops/Positive/human_smop_000747.jsp&mid=WC0b01ac058001d127
http://www.clinuvel.com/en/news/company-news/new-england-journal-of-medicine-publishes-pivotal-phase-iii-scenesse%C2%AE-studies
http://www.nejm.org/doi/full/10.1056/NEJMoa1411481?af=R&rss=currentIssue&;;
It appears that the EMA was and still is worried that Scenesse will be used by people who just want a nice glow through sunless tanning. Therefore, the scrutiny reached the absurd, but finally, the CHMP approved Scenesse as a profylactic treatment for people suffering from the extreme light intollerance disorder, EPP in all European countries.
http://www.clinuvel.com/en/scenesse/epp
Investors were thrilled. For more than a decade many had witnessed the PPS decline or stay at depressing levels. But many, my self included, didn’t want to sell because of the potential of Scenesse. In my view, this is truely a drug that can change the world. Now, the historic approval paved the way for some exictement, and the stock went up quite a bit following approval. But the EMA had more hurdles in store for Clinuvel. They wanted a comprehensive post-marketing risk plan (RMP) in place to avoid off label use of the tanning agent. They seems to be afraid that people will stop using the dangerous tanning beds and turn to the safe and protective alternative: Scenesse. It seems stupid but that’s the way the regulative system works. For almost a year, Clinuvel has been working on such a safety program involving monitoring of all the patients who recieve Scenesse and a post marketing study as well. That has led to the declining share price but lately the share price seems to be going in the right direction due to imminent and final PRAC approval of Clinuvel’s safety program.
Another reason for the declining share price was that New York Based company, Retrophin (RTRX) tried but didn’t succeed with an unsolicited take over of Clinuvel.
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB4QFjAAahUKEwihwr39x93HAhXFaT4KHdJmBjs&url=http%3A%2F%2Fwww.clinuvel.com%2Fen%2Finvestors%2Fnews-publications%2Fannouncements%2F2014-announcements%2Fclinuvel-declines-unsolicited-proposal-from-retrophin&usg=AFQjCNHJzsB_oq-_PKPuSSnpCWqugPlx7Q
Prior to the takeover proposal Retrophin, under the supervision of the former CEO Martin Shkreli, had been accumulating millions of shares in Clinuvel, and when Clinuvel declined the offer and Shkreli was ousted from Retrophin, the new management decided to sell all shares in Clinuvel.
http://biz.yahoo.com/e/150511/rtrx10-q.html
This caused a huge selling pressure and most likely caused the share price to depreciate along with investor fatigue because of the new safety requirements following the long awaited EMA approval.
But now we seem to approach crunch time. Scenesse will be sold in the first European countries this spring and the company is in talks with the FDA about accelerated approval in the US while patients and organizations put tremendous pressure on the FDA to approve. Furthermore, full trial results from the Company’s Phase IIb in Vitiligo performed in Singapore are due anytime. If the results are positive, investors will probably begin to see how extremely undervalued this company is. Former trial results bode well:
http://www.medscape.com/viewarticle/832214
Now, lets play with some numbers.
Shares out: App. 47m.
Market Cap: $150m. (USD)
EPP:
Prevalence is said to be 1:75.000 to 1:200.000.
Many patients are know by the specialized porphyria centers in Europe and the US but due to general unawareness of the conditions many patients are believed to be undiagnosed. Roll out of Scenesse will most likely change that.
Europe: App. 4500 patients.
Price per implant is now roughly $25.000 USD. I expect the price to fall to app. $22.000 when negotiations have taken place in Germany and the British HST under NICE has evaluated Scenesse later this year. Patients will get 3-4 implants per year to be protected from UV and visible light throughout the months with the most sun.
That’s + $400 million per year for Europe alone with full coverage. Costs will be low because Clinuvel is distributing Scenesse directly to the porphyria centers who have already been working closely with the company throughout the past decade. Lets be conservative and assume that 25 % is spent on running the business and that 1000 patients will get the implant fairly quickly. Considering how desperately they are awaiting the implant, that’s not a long shot.
That's app. $66 million / 47 m s/o = 1.4 EPS. A ratio of 20 is not unimaginable. That's $28 for EPP alone. Low ball.
With more European patients this number will go up exponentially. Add FDA approval and that number will probably double.
Also, the company is develloping a melanocortin analog for topcal use through their 82 % stake in the Singapore joint venture, Vallaurix. It’s meant as a pediatric version for of the implant in the treament of EPP and as a follow up for Vitiligo. But imagine when the word gets out that the already approved tanning implant is about to be released as a cream. Future on and off label use is not priced in the EPP numbers at all.
VITILIGO:
http://www.ncbi.nlm.nih.gov/pubmed/19608058
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0CDkQFjADahUKEwj7tMC0z93HAhXKNj4KHcHVAPE&url=http%3A%2F%2Fwww.clinuvel.com%2Fen%2Finvestors%2Fnews-publications%2Fannouncements%2F2014-announcements%2Fscenesse%25C2%25AE-vitiligo-study-results-published-in-jama-dermatology&usg=AFQjCNGIu_G_tcUZDDLMDrZ1quPpQbKxKA
Prevalence is app. 50 m. world wide. Let’s assume that the price per implant drops significantly when such a broad patient population will have access. But even with a very low price per implant of let’s say $500 and 5-10 required implants in the combination therapy that’s $2500 – 5000 per patient.
With app. 3.200.000 Vitiligo sufferers in the US (Michael Jackson was one of them) let’s say that 5 % will use what I believe will become the new standard of care: Scenesse in combination with narrowband UVB.
That’s 160.000 patients yearly and between $400 – 800 m. Clinuvel will most likely require a partner to perform the last Phase III trail and to bring Scenesse to market to treat Vitiligo, so let’s assume that Clinuvel can keep 40 % (on top of up fronts and milestones that I leave out just to be conservative.)
That’s a share price of <$71 for Vitligo in the US using very very conservative numbers. I believe that Vitiligo could cause the share price to go above $200 but I don’t want to be ridiculed as a dreamer.
LABEL EXTENSIONS:
Clinuvel has stated that they will seek label extensions for some of the many other conditions that involves intollerance to light. They have performed numerous phase II and III trials and I see many obvious label extensions down the road.
http://www.clinuvel.com/en/scenesse/clinical-results
http://www.clinuvel.com/en/scenesse/ongoing-clinical-trials
OWNERS:
Facebook founder Sean Parker owns app. 4.5 % ow the company. Lagoda Investment Management owns a little more than 10 % but it does not show in their 13F filings but it shows in the ASX filings:
http://www.asx.com.au/asxpdf/20160411/pdf/436fg7v0dtxdll.pdf
Besides some vert loyal significant private investors there is also strong institutional backing.
Latest institutional ownership:
Fidelity Funds SICAV - Pacific Fu... 6.74% 3,170,824 10,526,184 +700,100 +28.34%
Fidelity Asian Values Plc 1.45% 682,942 2,267,163 +150,721 +28.32%
Fidelity Funds SICAV - Asian Smal... 0.81% 381,567 1,266,688 +84,211 +28.32%
Fidelity Japan Japan/Asia Growth ... 0.28% 132,512 439,900 -5,323 -3.86%
Perinvest (Lux) SICAV - Global He... 0.14% 66,000 219,100 +66,000 --
NEF - Azionario Pacifico 0.12% 57,072 189,462 0 0.00%
Wagner & Florack PIC Fund AMI 0.12% 56,302 186,906 0 0.00%
DFA Asia Pacific Small Company Se... 0.10% 46,902 155,701 -1,919 -3.93%
Fidelity Funds SICAV - FAWF Pacif... 0.09% 43,113 143,122 +4,887 +12.78%
Smith & Williamson Unit Trusts - ... 0.08% 37,441 124,293 0 0.00%
Disclaimer: I am long Clinuvel with a large number of shares and I am still accumulating. I have been in this stock for + 10 years and I have never sold a share.
I believe that Scenesse will revolutionize the way humans protect themselves against the sun and UV. I also believe that off label use will be the norm sooner rather than later when the FDA approves Scenesse for EPP and / or Vitiligo.
In my view this is partially self imposed suffering. Had the CEO been a more mature communicator we would not be here today.
I'm not complaining about volatility per se. That's life as you say. I'm a seasoned bio-investor. I know. I'm complaining about what I see as self imposed pain and suffering due to amateurism and incompetence when it comes to the PR part of the company. Pretty much everything else they do, I can live with. But the PR part has now been so ridiculously poor and self destructive for so long that it is obviously hurting the company. Lower pps = higher cost of raising money. And the way the CEO communicates is very much causing the low pps.
Yes. Dr. Minder has been advocating for 6 implants a year for a long time. The EMA suggests that 4 implant per year will be the maximum but it does not seem to be a mandatory cap. Dr. Minder recommends 6 implants to all patients who are severely affected also by artificial light. I believe that Rocco has been on 6 implants for almost 10 years now. He is a good example of why there is no need to restrict it to a maximum of 4 implants.
I think it's frustrating that a relatively well run company with such promising science and a great track record as CTIX still shows so severely poor PR and media strategy skills. I wish the CEO would hire a consultant and stop conveying useless information to the market. Other companies I am invested in communicate when there is something to communicate. That results in a less volatile share price and a much higher level of trust.
Whoever just sold 15.000 shares must have been living under a rock for quite some time.
Germany is now online as of today.
Congrats all. Especially the German EPP patients.
Scenesse seems to be now formally released in Germany according to this google translate of a letter to the German EPP association.
* 1Bundesinstitut for drugs
BfArM, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn
EPP e.V.
Elke Hauke
Email: elkehaukeeyahoo.de Cc: vorstandeep p -deutschland.de
Episode request SCENESSE, Afamelanotide
Your character and message from: 25/04/2016
Dear Mrs. Hauke,
and Medical Devices
We refer to your inquiry of April 25, 2016 and e-mails to various persons in the BfArM of 21 March 2016 and the questions expressed are the start of treatment in Germany or to the outstanding steps. For this purpose we can len notification feature
According to additional requirement for the safe and effective use of SCENESSE® the MAH / Pharmaceutical entrepreneur pursuant to Annex IID of the product information bulletin the following additional risk minimization measures to fulfill (Clinuvel):
Before the introduction of SCENESSE in all Member States the holder of the marketing authorization with the competent national authority has to speak the content and format of the infor- mation package, including communications media, delivery modalities and other aspects, off. The holder of the marketing authorization shall also adopt agreements regarding the details of the program for controlled access, to ensure that SCENESSE is only issued to centers where doctors have received the information and have been trained appropriately.
The holder of the marketing authorization ensures that in all Member States, in the SCENESSE comes on the market, all healthcare professionals who are expected to apply the product, obtain the following information pack and be trained:
• Summary of Product Characteristics
• Material for Classroom
• Register information sheet.
The tuned according to admission requirements with the BfArM training materials for doctors of treatment centers as well as the details of the controlled distribution system were the BfArM mostly first filed in February 2016 and have been tested here then as soon as possible. It has been shown that for. T. extensive revisions were necessary, the BfArM has done with concrete information and formulating proposals, considerable assistance for the marketing authorization holder. This has the BfArM - different than usual - fulfilling the admission requirements with own personnel resources supported strongly un-. The latest materials, including some of the material for classroom training, were approved the necessary changes to the 04/20/2016. These changes, the company Clinuvel approved on 22.04.2016 and 04.25.2016, so that now all of the materials in connection with the training package for doctors or medical professionals in the treatment centers as well as in connection with the controlled distribution system from the final BfArM are approved. A corresponding notice to Clinuvel took place on 25.04.2016.
There are thus no longer open to aspects that require te before a marketing SCENESSE in Germany or in front of the required training of doctors and medical skilled specialists in the treatment centers of coordination with the BfArM.
We assume that those placed in your letter expressed concerns have been taken into account in appropriate manner with this date. Precisely because of the special situation of patients whose has always proactively taken the initiative to allow a speedy market access BfArM. If you want to visit us despite Now that the clearance with a delegation of your association, we are sure happy avail- able.
Hey Jest. Shoot me an email @gmail.com
A new article posted online:
http://www.genengnews.com/gen-articles/photoprotection-finds-its-place-in-the-sun/5752/
Thanks Karin. I think this might be the last quarterly before we will see higher sales numbers. I truly believe this is the calm before the storm.
Absolutely nothing new. Still waiting.
GLTA. Especially all the EPP patients who have endured this for so many years.
No. I don't think we will learn anything in the report. Price negotiations must still be ongoing and no significant sales have occurred so far IMO. I don't think Düsseldorf have chipped any patients yet. It would have been reported by the EPP community online. So I'm not holding my breath right now.
One thing, thought, that Jasmin kind of confirms is that Clinuvel is aiming for a price per implant around €20.000. Today the price is a little more than €6000 for the special access schemes. 3 X €6000 =
€18.000.
I agree that reimbursement seems to be an ongoing and probably tough one. But Jasmin days that her insurance company has been paying for her implants in Switzerland and now refuses. That confirms an active price hike in Switzerland but it doesn't say anything about where the negotiations will land. Hopefully, the HST will be a guiding star for Europe.
Jasmin has been wrong before. Remember the post in the German EPP site. They thought that it was the PRAC holding everything back.m and they even travelled to London to protest at the EMA only to find out that the PRAC gave its green light in September.
Jasmin is not in the know more than we are.
American EPP patients in another strong push for accelerated FDA approval of Scenesse.
https://www.facebook.com/groups/AmericanPorphyriaFoundation/permalink/1378144705545034/
Good luck. I think your timing is great.
Nice volume today. If not this week, next week will bring news of some kind.
Dr. Minder recommends 6 implants per year and those patients who are also very allergic to artificial light demand 6 implants. Hopefully they will get it.
Thanks a lot, Jest. Glad it can be of help - also to new investors who will soon come to this board.
Thank you very much for your input.
Dutch EPP patients are tired of waiting. April 11th they made a happening at the EMA in London.
https://www.facebook.com/EPPNederland/posts/744276129047725
Hopefully, the waiting is soon over.
Jest, my understanding about the ADRs is that they are
depository receipts that you get when you ask Bank of Mellon
to purchase one Clinuvel stock in Australia. You don't own the
stock per se, but you own a paper stating that you own the stock.
Hence, there can't be more shares out that what is listed on the ASX.
There is no designated ADR pool, to my understanding. Please correct me if I'm wrong.
Next week could bring a PR stating that the first German patient has gotten the implant. We're very close with the PRAC concluding this week and obviously very few obstacles to overcome - if any left. Pricing is the big unknown.
Have a great weekend, all.
Sorry if his has been posted already.
http://seekingalpha.com/instablog/47025436-do-diligence/4871551-getting-caught-short-signs-changing-regulatory-environment
Thanks Karin. Yes. The company is very close to treating the first patient after the EMA approval. They have treated more than 100 patients in Switzerland and Italy through special access schemes for a decade but treating patients across Europe at a new higher price will be monumental.
The EMA has put in place some very comprehensive (absurd) safety requirements because they fear off label use. But it seems that everything is now ready to begin actual treatment.
We still don't know the price of the implant. Very soon we will and if it is higher than the market expects the pps will act accordingly.
I believe that EPP - even though only seen as a foot in the door by many - will be a value driver beyond expectations. Patient demand is high. Everything is kept in house. NICE HST is evaluating reimbursement in England meaning that the price for one years treatment exceeds £30.000 GBP / $42.000 USD. £30.000 is the the limit where NICE usually does not reimburse medicines but HST is the scheme for orphan drugs at high costs and low prevalence.
I think we are in for a nice spring. And most importantly: The EPP sufferers are about to receive the treatment they ought to have received years ago. These people's lives are about to change to the better. Dramatically.
GLTA
I still think an NDA can be filed in 2020 after one PH2 and one or two PH3s. If we're lucky it will be before.
This video was posted on SS and is a must see for Clinuvel investors:
http://www.umassmed.edu/vitiligo/blog/blog-posts1/2016/03/vitiligo-truth-hope-and-change/
Around 7:40 you'll see a woman who participated in the US Clinvuel Vitiligo trial. 3 years after the trial she still has lasting pigmentation ! This is very positive and I think - based on this and all the other trial results we have seen - that the Vitiligo program will be very successful.
Usually Germany and Britain are used as reference countries due their systems. Germany accepts the initial pricing without much questioning for the first year and Britain has the NICE system as we all know. With price established in those two countries we will know for sure what price Clinuvel will ask in all other EU countries. Most likely, Germany will be the first country online and the price here will very likely be the price that Clinuvel is asking from NICE as well. Many other EU counties look to e.g. Britain to establish a price. But look at the link I posted previously. It says everything about how the different EU countries handle reimbursement issues.
Up almost 90 % in Canada due to insider trading. Probably Melnyk preparing to take over the company.