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I think you slightly misunderstand the purpose of my post.
I'm not saying these are the final numbers. Just trying to be very conservative in arguing that the company is undervalued.
App. $5-6000 is the price Clinuvel has asked for the implant so far in the two special access scheme countries. There is no way they will keep the price that low.
1000 patients is what I expect they can get within the first year. I expect the uptake to be significantly higher later but 100 % uptake is unrealistic.
I like that idea. Thanks for clarifying. If someone with more experience in legal matters than me wants to take lead on this in in.
I have been thinking about wether an open letter to the judge from the true CTIX investors (us and not the plaintiff) would bear any weight.
It's hard to witness a single so called investor take down "our" company in a fake class action.
If a large group of long time investors teamed up and wrote an open letter to the judge it would send a strong signal that there is no class in the action so to speak.
Much has been said about valuation of this company, and due to its pre-revenue state it's all highly speculative. However, I stand by my previous valuations and believe, that Clinuvel ought to be at $10 today.
In this post I will show, why I think even the most conservative valuation still leaves room for a 100 % increase as an absolute minimum.
Today, it seems that the market assumes that the implant will be sold below the current price collected in Italy and Switzerland: $6200.
Or, the market believes that only very few EPP patients will receive the implant within the next year(s) in Europe.
Before doing the math, I will argue that Vitiligo and all other programs are worth at least $1 per share or app. $50 million in market cap. I can't imagine any mid stage biotech company with numerous patents, orphan designations and completed phase II and III for a drug with Scenesse safety profile not being valued at least $50 million in market cap.
Therefore, the first Dollar of the current $3.22 (US) I ascribe to everything but EPP. I think that is very reasonable.
We are at app. 47 million shares outstanding and a market cap of $143 million (US)
Let's say that the $43 million is the value that the market puts on the Vitiligo program, the topicals, the patents, the ODDs and everything else Clinuvel owns.
The $100 million must therefore be the markets valuation of the EPP program. App. $2 USD per share.
Today, the implant is sold in Italy and Switzerland as part of the special access schemes in these countries.
The price is app. $6.200 USD per implant.
Assuming that Clinuvel will get 1000 EU patients within a year or so, which I believe is very realistic, and using the current price and 3 implants per year (even though Swiss patients receive 4 per year today) the calculation would look like this:
1000 patients X $6200 per implant X 3 per year = $18.6 million USD.
Let's use the lowest imaginable price to sales ratio: 5. That brings us to $ 93 million USD.
$93 million divided by 47 million s/o = $1.97 pps.
Add the $1 I believe that everything but EPP should be worth at the very least and the pps ends at app. $3 USD.
The market seems to believe that Scenesse will be sold for the current price to less than 1000 patients OR for a higher price to an equally lower number of patients. Both scenarios seems unrealistic to me.
I strongly believe that Clinuvel is seeking a price per implant that is aignificantly higher than the price the two special access counties (compassionate use) are paying. Otherwise, the company wouldn't be engaged in negotiations with the British NICEs special HST division that only deals with medicines that are expected to be priced at a very high level due to the orphan nature of the indication.
Let's assume that the implant will cost $10.000 and that 1000 patients will only request 3 implants per year (again: calculations show that Swiss patients are requesting 4 per year).
Then the math looks like this:
1000 patients X $10.000 USD per implant X 3 implants per year = $30 million.
Price to sales ratio: 5 = $150 million or app $3 USD per share. Plus the $1 from all other activities and the pps should be $4 USD.
Now, $10.000 per implant is unrealistic. 3 per year is also unrealistic. A price to sales ratio of 5 is very low and $50 million for all other programs for everything but EPP is also very conservative.
I think the implant will be priced at $15-20.000 (minimum) and that patients will require 4 per year and that the company will get more than 1000 patients very quickly. I also think that the validation of the EPP program and the fact that Scenesse is now marketed adds more value to all other future operations of the company. The likelihood of Vitiligo, HHD or many of the other indications being brought to market is greatly enhanced now that the implant is marketed in EPP and this adds to the intrinsic value.
Therefore, I believe that fair value today is $10 USD and that we could go significantly higher within the next year(s).
The most pessimistic or conservative way of assessing the company's fair value today results in a pps of $4 USD.
Therefore, there seems to be no downside and plenty of upside at the current $3.2 USD.
All IMO of course. Another effective therapy could emerge tomorrow, Scenesse could lead to melanoma or an alien attack could wipe out the company.
This is a good read. Tells you all about it.
http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR240/RAND_RR240.pdf
The wider scope of Scenesse:
For newcomers it might be interesting to know what the future might bring once Scenesse is successfully marketed for EPP, which is about to happen as I write this.
I don't have time to look up all the links to substantiate the following, but you can look it all up - it's there.
1) Scenesse is highly effective in HHD and has completed a physician led phase IIa in Italy. I expect label extension for this condition.
2) The FDA is sympathetic to the EPP sufferers and the APF is pushing hard to get the drug approved in the US ASAP. I believe it will happen either this summer or the next.
3) Scenesse has been trialed in numerous conditions, and I think we will see label extensions or off label (in the US) for these conditions: SCC, Rosscea, OTC, PMLE et al.
4) Scenesse has proven accelerate repigmentation in Vitiligo and this is backed by the Worlds most renowned scientists and numerous trials. A US phase III will put Scenesse on the brink of becoming standard care for millions of sufferers.
5) Scenesse (a-msh) activates p53, holds DNA restoring properties and is a potent antiinflamatory agent. These properties are not even fully explored by the company as of yet.
6) Scenesse cleared up acne and psoreasis completely in small trials.
7) Clinuvel holds numerous interesting patents for other uses of afamelanotide. E.g. as a general UV protectant for redheads who are much more at risk for developing skin cancer.
8) Scenesse is developing CUV9900 and VLX001 - two topical a-msh agents that can be used as a pediatric version of Scenesse, a self administered follow up treatment for Vitiligo, a general protectant for skin cancer and the application that we do not speak of. Begins with C and ends with osmetic.
9) If you go to google groups and read some of the amazing research Uho has made throughout the years you will see that this is only the beginning. Scenesse is a wonder drug with many applications. EPP is only the beginning.
I know, Jest I was just wondering why you brought it up now.
Yes. But at some point I believe they will uplist form the ASX to Nasdaq or another major exchange. The CEO has said, that he is considering the pros and cons and I have to admit that being on the ASX shields us from short attacks and manipulation. I think the uplist will happen when they are in a solid financial position to do it right. 1-2 years IMO.
Also, the reason for the low volume is that this stock is mostly held by longtimers and large holders who aren't selling. The real float is very insignificant and once there is a demand by new investors and institutions the won't be many shares up for sale. I have been her for +10 years and so have many others. +$20 might make me consider doing something with my trading position. But not before. And the long position is here to stay.
NICE holds workshop on Scenesse in Britain:
http://www.asx.com.au/asxpdf/20160324/pdf/43624r325pn09g.pdf
Based on this, I expect an absolute minimum price per implant to be $15k.
German EPP patients are about to get the implant for the first time and in the coming days we will know at which price. I expect same pricing level throughout Europe so as soon as we know the first country's reimbursement level we should be able to calculate a fair price for the company's market cap.
I believe Vitiligo should be worth &2-300k today risk weighted.
EPP $5-600k. With a little luck we could approach $1bn market cap within the next year.
CUV9900 ??
Welcome onboard, Karin. Delighted to have you here. I know you do very thorough DD and that you are a very knowledgable person and investor. I wish you all the best with your investment here. This is by far my largest holding, but we have a mutual passion for the other one as well. We are fortunate to have found both.
Hear hear
52 weeks high. Still a good entry price, though.
I hope he will stop the constant flow of PRs that do exactly nothing. Timely and professional updates is what this company means. It's dangerous to become a PR junkie.
Beware. I regret ever investing in this company. One big drama. I have written off my investment and do not expect to get anything back. If Melnyk succeeds in taking over the company, I might have a chance of seeing my money again.
NEW INVESTORS CAN BEGIN HERE - UPDATED
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 already obtained EMA approval late last year for the absolute light intollerance disorder, EPP de-risks the stock tremendously. 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 imminent.
CLINUVEL:
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 (still not official but probably) +$10.000 USD. Patients will get 2-3 implants per year to be protected from UV and visible light throughout the months with the most sun.
That’s app. $135 million per year for Europe alone. Costs will probably 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. That's app. $100 million / 47 m s/o = 2.1 EPS. A ratio of 20 is not unimaginable. That's $43 for EPP alone.
Add the US EPP sufferers 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 an off label use is not prices 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
Disclaimer: I am long Clinuvel with a significant 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.
A memorable and pivotal night in the company's history.
A capital raise carried out without a discount at 3.30 AUD.
http://www.asx.com.au/asxpdf/20160315/pdf/435v33fzf94sv4.pdf
Lagoda Investment Management bought the new shares and now almost owns 10 % of the company. It seems they can't get enough. Very encouraging and significant.
http://www.asx.com.au/asxpdf/20160315/pdf/435v52hvvsmffr.pdf
And a roll out of the implant is now a fact.
http://www.asx.com.au/asxpdf/20160315/pdf/435v52hvvsmffr.pdf
With price negotiations pending we still have some uncertainty but it is nothing compared to what longs have endured over the past years.
Clinuvel is grossly undervalued. EPP alone will propel the pps to a much higher level. Label extensions, Vitiligo, pediatric EPP and the cream will do unimaginable things the the pps.
And most importantly: 1000 of patients with a broad variety of horrible disorders are about to benefit from this wonder drug that has such a huge future.
GLTA
Thank you again !!
Thank you so much. I appreciate it a lot. Was just wondering how to read the full response from Rosen and not only the index page.
Hi Karin,
Are you still monitoring Pacer for a Rosen update ? Nothing up yet ?
Thanks a lot
Thanks for posting. I hope the judge understands the value of this quote:
"Dana-Farber/Harvard Cancer Center sits at the pinnacle of cancer research and if a breakthrough is going to happen, it would seem logical that they want it to come through their center. They are well-funded and very prestigious. A Principal Investigator there does not want to be associated with a failure. So hosting a trial for any other reason than they like what they see and believe in the potential is the best answer that I can provide."
t's fairly safe to conclude that the implant will be priced at an absolute minimum of
$10.000 ~ 7.000 British Pounds.
NICE will reimburse drugs at a yearly cost of 30.000 Pounds ~ $42.000 without much hessitation.
Orphan drugs, however, are expected to cost much more and as a highly specialized treatment, Scenesse is - as we know - referred to HST evaluation.
Logically, Scenesse wouldn't have to go through HST had the price been lower.
If the company expects 4 implants per year to be the norm (as it seems to be in Switzerland and Italy) then $10.000 per implant should be pretty easy to squeeze through the normal
NICE procedure.
If we want to know what $10.000 per implant should do to the pps
it would look like this:
$10.000 per implant X 3 per year (conservative) X 0.75 (25 % in cost, conservative)
= $22.500 X 1.000 patients (we should get that pretty quick) = $22.500.000 /
45.000.000 shares out = $0.5 EPS X 20 ratio (Cochlear has a 34 ratio) = $10
per share.
This is my personal rationale to be buying all the way up to app. $10 unless of course
that the implant will unexpectedly be prices much lower.
Yes. This is the beginning of some very exciting years to come.
From now on I'll buy on dips all the way up to 10.
This is a timeline of Discover1 Phase3 of Dalbavancin.
If CTIX can get patients enrolled faster than the 18 months
it too Durata, it seems the the trial itself is very swift.
Study first received: April 18, 2011
https://clinicaltrials.gov/ct2/show/NCT01339091
100 % enrollment: September 6, 2012
Preliminary top-line data: December 11, 2012
Additional top-line data: January 4, 2013
http://www.duratatherapeutics.com/news-media/press-releases/detail/7944/durata-therapeutics-meets-primary-endpoints-for-ema-review
SEE ALSO:
http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4017
The PDUFA goals for special protocol assessment and agreement provide that, upon request, FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements.
But hey, does it really matter if the Ph3 starts in April or May ? What's important is that the company chose to engage in SAP guidance which is voluntary and that this interaction with the FDA usually leads to a more robust trail with even better chances of approval once the NDA is submitted. Very prudent step by management.
I know it's been discussed extensively but I simply lost track of how much "we" anticipate that Aruda would have left to sell ?
Exactly
I think we need to remember that Clinuvel hasn't formally submitted an NDA in the US. FDA can't approve a drug formally without the submission of a dossier.
They have other options, of course, but full approval is not possible before the company sees the time fit to submit an NDA.
I think the APF is somewhat forgetting this.
If EPP suffered in the US are to benefit from Scenesse this coming summer, which I truly hope will be the case, then compassionate use or some other unconventional opportunity needs to present itself.
As for the delays in Europe I think it's a matter of the EMA being overly cautions and fearing that Scenesse will be used off label.
Also, the company clearly made a lot of rookie mistakes and probably still is. However, I think they will succeed and the sufferers will get the treatment they deserve. I can't imagine how painful and frustrating it must be knowing that a solution is out there but you cannot get it.
As for off label: It is very unwise and extremely counterproductive to dream about off label and the fact is that investors don't need off label to get a good ROI. There are plenty of legit conditions out there that need treatment with Scenesse to catapult the pps to hights that no one cannot really predict at this time. EPP could easily justify a market cap of $500-700 m. Vitiligo is not at all priced in at this time. Fully approved Vitiligo will be worth at least $3-5 m. in market cap.
Then add label extensions for HHD and all the other conditions that the company ran trials on. Then add pediatric EPP treatment which in my view is by far the most important place to focus for the company tight now from an ethical point of view.
And if a topical solution for the children through the Singapore JV will lead to a topical solution for the adult population as well then it is also good for investors.
Bottom line: We don't need off label. We should salute management for preventing off label because it it counterproductive and will only upset regulators. I believe the company will fight off label and that it is the only right thing to do.
GL
Hi,
You're right. We need to look at PACME. Price after cost and marketing expenses.
But marketing and distribution is very cheap for the company. They more or less know all the patients, doctors and the porphyria centers by name.
But you're right. We need to subtract expenses. Still, there is room for some explosive price action in the near future.
At this point it seems that Vitiligo and label extensions are not even prices in.
Courtesy of Seeva222 the implant price might be as high as $35k.
That's significantly higher than what I expected. Per the 2014 company presentation management compared EPP to Hemophilia which costs app. $50k per year per patient. Therefore, I was expecting $15k per implant which would be $45k per year assuming a yearly average of 3 implants.
$35k per implant would be $70k at an average of 2 implants just to be conservative.
The company sets EPP prevalence at 1/140.000 which would bring the number of European EPP suffers up to app. 4500.
The company is launching Scenesse in the 17 key European countries with porphyria centers which means that the patient population is very well known. Let's assume that the 17 centers have an approximate total patient population of 3000 patients. It's totally reasonable to then assume that Clinuvel will have 1000 patients implanted in 2016.
1000 implants X $35k = 35.000.000.
EPS = 0.77 X a conservative ratio of 20 = $15.5 per share.
I do not know the source and I therefore don't know if $35k per implant will be the actual price.
But even at $15k per implant we should be a $5 today. Conservatively.
GLTA
Sorry for not responding. The GG is closed down - maybe it will reopen at some point.
Exciting times. I think we will see a flood of label extensions in the coming years, a partner for Vitiligo and hopefully a pediatric / topical out of Singapore sooner that expected. Wishful thinking. But we're about to roll for sure.
GLTA
Hey Sante. I agree that the stock is very cheap right now. I don't agree, though, that ShareScene is solely a good board. Many trolls and odd people posting. A few good posters but you need to steer through the crap.
Dawn of a new era.
Scenesse will be offered for sale for the first time ever...:
February 15th in Germany.
http://www.drugbase.de/de/datenbanken/abda-datenbank/aktuelle-infos.html?tx_ttnews%5Bpointer%5D=4
The company has stated that they a seeking a uniformed pricing model in the 17 key European countries which means that they must be close to or already have concluded the negotiations with payers.
GLTA.
And this. January, 2008:
Management
Chief Executive Officer - George W. Evans, JD, MBA
Former Senior Vice President, General Counsel Human Health and Associate General Counsel, Pfizer Inc., New York, NY
President, Chief Scientific Officer - Krishna Menon RCM, PhD, VMD
Responsible for the development of the anticancer drugs Cryptophycin and the blockbusters, Gemzar and Alimta. Annual revenues $2,500,000,000 (Billion) /Yr
Chief Financial Officer - Leo Ehrlich CPA
Mr. Ehrlich has over 20 years experience in business development and capital structuring of companies.
Scientific BoardScientific Board
Har Gobind Khorana, PhD; Nobel Laureate; Scientific Advisor,
Nobel Prize Winner
Responsible for producing the first man-made gene, Dr. Khorana has also won many awards and honors for his achievements.
Emil Frei III, MD; Scientific Advisor
One of the world's leading oncologists. Former Chief of Medicine at National Cancer Institute, Associate Scientific Director at M. D. Anderson, and Director and Physician-in-Chief at the Dana-Farber Cancer Institute.
from ceofrom ceo
In over 25 years working for a very large pharmaceutical company you may have heard of--Pfizer--I learned a few things about the pharmaceutical business. Perhaps the most important thing I learned is that the vast majority of the value in the business comes from very few things. Two of the most important are high quality data and patents. An organization that spends most of its time on critical value-creating issues, should be able to create value for shareholders without wasting a lot of time and money.
I also learned a few things about large organizations. I learned that large organizations have vast resources and expertise but they tend to be slow, bureaucratic and afraid of new ideas, especially from outside.
At Cellceutix, we have an exciting pipeline. We have the expertise of a large pharmaceutical company, but we're also focused, nimble and willing to supplement our own creative energies with ideas from the outside. We're focused on our lead candidate, Kevetrin, which we plan to develop for head and neck cancer. And we're focused on developing high quality data and patents to support Kevetrin. We're also open to new ideas from outside as well as inside. As a matter of fact, our pipeline already includes compounds licensed from the outside to supplement those invented by one of our co-founders, Dr. Krishna Menon. We're willing to partner with anyone who will help us meet our goals.
When you put all this together, it means we at Cellceutix have a very exciting opportunity to create real value for our shareholders, as well as for our ultimate customers, the patients.
George W. Evans, JD, MBA
Chief Executive Officer
Latest NewsLatest News
What ever happened to Dr. Danishefsky ?
https://web.archive.org/web/20101006174422/http://www.cellceutix.com/news/cellceutix-announces-dr.-samuel-danishefsky-joins-its-scientific-advisory-board.html
Btw: The Internet never forgets, and using the Wayback Machine you can browse through the company's website history all the way back to 2008. It's a goldmine of interesting info.
I wish it didn't say Rosenfarb but Rosen in this PR. Judge Cote seems to be a cool judge.
From: https://gigaom.com/2013/12/05/judge-to-punish-lawyers-for-frivolous-lawsuit-over-aol-microsoft-patent-conspiracy/
Giant tech companies don’t usually cut sympathetic figures in court but, on Thursday, a federal judge in decided that the lawyers who had been harassing them with a frivolous lawsuit deserved to be punished.
In a decision issued in San Jose, U.S. District Judge Lucy Koh — last seen overseeing the Apple-Samsung patent damages trial — found that a lawsuit that accused AOL(s aol) and Microsoft(s msft) of cooking up a bogus patent auction with the help of Goldman Sachs was “frivolous” and “utterly lacking” in facts.
The lawyers in question will have to pick up AOL’s legal tab, and Judge Koh is also preparing to set out other punishments, which could include fines and disciplinary measures.
The case in question came about after AOL sold a portfolio of patents at auction to Microsoft for over $1 billion in April 2012, causing AOL’s share price to soar. One month later, the Rosenfarb Law Firm hit AOL with a class-action lawsuit that alleged that the auction was a “sham” and that the two companies had decided to do the deal months earlier.
The point of the purported “sham” and “secret deal” was to depress the price of AOL’s shares, allowing the company to buy them back before they popped on the news of the auction.
The court initially threw out the claim when it learned the allegations were based on a single, pseudonymous blog post. The lawyers then tried to claim that a Reuters news story pointed to a conspiracy, but the court found the story described nothing of the sort.
You can read Koh’s order here, which was spotted by the SDNYblog.
Agree. And by re-enrolling and continuing the ph1 they save time while exploring the wider possible use of K instead of having to do new ph 1/2 or 2. Again, this could also lead to an application for breakthrough designation of the data is strong enough. DF would never do this and spend money on an extended ph1 where safety has been proven a long time ago if they did not see possible efficacy in the horizon.
Lagoda Investment Management keeps buying all the Clinuvel shares they can get their hands on:
http://www.clinuvel.com/index.php?option=com_k2&Itemid=738&id=511_ab33260a11f7c0195e8fd8d802abbb40&lang=en&task=download&view=item
Now own +8% of the company.
Welcome back !