And my point is that the drug approval system under FDA and EMA is broken. No drug should take so long, not just Scenesse. No company should have to guess or waste so much effort and expense with such an incredible failure rate. The societal cost is inefficient and against progression and people suffer. And with Dr. Wolgen now with a large portion of stock in Clinuvel, has no reasoning to sell out the little investors to a golden parachute sweetheart deal with a bigger pharma. His shares and there valuation are going to go where ours does. These negotiations over price, has some of the same human innate nature as when dealing with a used car salesman, or a greedy auto mechanic, or an internal revenue officer during an audit, but much higher costs and the fate of our stock at stake. I live near Indian casinos and have watched and know some professional poker players. The cards eventually average out, but the silent negotiation where the most important communication is non verbal!, the mental trepidation and correctly reading the other player is incredibly tense and some of these guys make money out negotiating the others. I have known some of the best and most tenacious negotiators, one of them whom owns this stock, and he can wear anyone down to give up. I suspect Dr. Wolgen is a hard adversary from some of his characteristics which have manifested, and he is apparently negotiating the best deal he can with the hand he has. Unlike a poker game, the regulatory price negotiators start with many advantages. With the Italians Drug Agency coming out with todays press release and explaining, I would consider Clinuvel to ..................................can not state what I think would interfere with Clinvuel, as the "regulators do read the stock investor websites."
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Maurice
5/7/16
I think we are talking different issues. I certainly agree with you about the regulatory process being far from optimal and I think its moving in the wrong direction. For example FDA pats itself on the back for improving their meeting of PDUFA goals but in reality they extended regular and priority reviews by 2 months to meet that goal.
My comments were directed from an investor standpoint on being able to execute the drug approval/launch process which I think Clinuvel has done sub optimally and informing probably worse than any company I've ever followed. I don't have an opinion on their discovery capability though from the clinic to launch I have a negative opinion. Whether one licenses early stage (BMRN often got compounds from Universities/research in the preclinical stage), acquires (ITMN acquired Pirfenidone from Marnac/the inventor Dr. Margolin), in licensed/acquired later stage (what Shire mostly did) or a combination (like Genzyme). To me its a matter of execution which if done well gets reward in the stock price. Though they all had their various issues all my examples did well at almost any point for long term investors and more pertinent to my example executed the approval/reimbursement process in Europe (and not only that but leveraged that to launch in countries that use Europe as a reference) in a more timely and less problematic manner.
BMRN's first three drugs time from IND to approval are 5.25 years (Aldurazyme), 5 years (Naglazyme), 3.25 years (Kuvan). Yes maybe management deserves some credit for getting the drug approved (in Europe) in an another indication but I would say that is far from enough to say they've done a good job.
When Intermune got Pirfenidone approved in Europe and went through the negotiation and reimbursement process they were pretty transparent about it and I got a fair understanding of it. That is why I don't see anything unusual with the country-by-country negotiations and the individual battles with reimburses be it governments or 3rd party payers. Dan Welch stated it well you try to get a pricing band where there is some variation between the highest and lowest country. It certainly wasn't easy and took time but they managed and were launching in countries as they did it. Clinuvel IMO had an added benefit of having 2 countries already providing drug! Italy is in poor financial position and I am sure that is part of the problem there, I recall other companies able to rally interested groups/organizations to support their reimbursement.
I won't rehash the debate on management I know we don't share the same opinion on them. I strongly believe they didn't do some things well (Their poor trial execution and delays helped me accumulate the stock) and while regulators haven't made it easy for them a good deal of the blame is with management.
Mark as complete
5/7/16
MrPoonz1 Fair comment.
me (Uhohinc change)
5/7/16
Not a fair comparison to start at NDA in my opinion. NDA has complicated and corporate patent strategics that interplay also. And Scenesse is a NME, the others I do not think were. And FDA and EMA hand out these and orphan drug status relatively easy, not representative of the timeline or success, and many more NDA's go no where for each one granted. Clinuvel actually beat every one of the four companys to EMA approval (or FDA approval) If you take the time from NDA then you would have to give credit for Clinuvel management for getting to the NDA a lot faster than the all the others. Bottom line of the four companies and Clinuvel, it was Clinuvel that when starting Clinuvel took from name change in April or about of 2005 and strategic redirection got from inception of program to market approval by 6 months to over 2 years less than any of the others. (and start is hard to define, but I place it at completion of a phase I and somewhere about the start of a phase II in humans which regulators must approve, and then the meetings with regulators begin and planning for longterm Phase II in humans, Phase III, some pharmakinetics, toxicology, and goal of market approval in a particular therapy)
In this link, Clinuvel's EPP program from start to market approval was 9 years and 5 months
http://www.lifescientist.com.au/content/biotechnology/article/clinuvel-gets-orphan-status-for-scenesse-in-hhd-589919273
https://www.google.com/finance/company_news?q=NASDAQ:ITMN In addition to all the problems I mentioned that transgressed with Intermune in my prior response post, many/some investors were dissatisfied and lawsuits were instigated to prevent the sell out at $74 per share to Roche, based on the then history of Intermune management prosletyzing prior that the company projections and sales and future placed it a more than double this eventual sale out price. This drug does not appear to have since had any effect on Roche stock up much or down, but Roche is so big it could be a ripple to it. So maybe in hindsight in which we will never know what would have happened to Intermune stock price, perhaps the investor lastly in the final days of Intermune did ok.
Here on the max chart for Biomarin,
https://www.google.com/#q=bmrn I disagree that investors could be happy in general, the stock has lost $70 to $80 per share in the last year. And I could not find where any of its drugs was acquired by BMRN (maybe indirectly by the prior but not directly) was raw research or bought from any university. Any drug as I listed on Wiki prior posts, was a drug that was negotiated from drug companies that sold out to them, and no longer exist. I can not find if investors from so far back are happy based on stock price and charts gone, but I agree most, but not all, would have to be much better off if they stuck with the drug(s) as it was acquired by BMRN as BMRN made out with such purchase in the looooooooong term, but only if in hindsight one can pick where they bought in, and sold. But only if we all could have been in at the low of BMRN and sold on July 1, 2014 at almost one hundred percent above the present day price. Your right, a lot of money was made on the BMRN stock because of the drugs it acquired if you compare the date of acquisition from the birth company of the drug to even today. But not by the investors whom bought on July 1, 2014 ! Iam sure some Epitan investors are not happy either, but it could have been much worse, a complete loss if he or someone had not agreed to step in and start over, at least W has raised capital and gotten an market approval.
I can not get a chart or history on stock prices for Genzyme, but I think in general, most stock holders in general, whom started early in when it acquired its first drug and rode it to approval on its first and subsequent drugs, in general, and whom sold at the right time could have done very exceptional stock price. But how did the first investors whom sold the drug to Genzyme come out and feel about their being sold out or selling out. Look what they gave up. Was their management ignorant, or was even Genzyme management ingnorant to have sold to soon to Sanofri....................And the first drug (orphan) it got approval for, which took about ten years plus, when FDA approved cost $200,000 per year......for life and was a major contributor to the sales and success for a disorder that has way more patients than EPP.
https://en.wikipedia.org/wiki/Genzyme What if W decided to sell out to Retrophin, I think the Retrophin stock investors would be happier, or even some Clinuvel stock investors could say they did very well even if they sell next Monday.
The same for Shire, did the orgin company of its drug before Shire acquired make out. Even when you look at Shire, it was many many years of time and no or slow increase, the stock chart can be interpreted so many ways for many investors. Down a hundred bucks or so from a year or so ago.
https://www.google.com/#q=shire+stock+price
In general, all these companies you cite, took at or more time than Clinuvel but we are looking back on them and can see their long ago outcome, we are still in the 12th year or almost, and still awaiting Clinuvel's out come which still has the chance to get revenues for EPP in Europe, not USA for an opportunity to have the cresting that most of these four companys did do.
I think you are right in that these companies, for all we know if we could have known what was goingon, got sales much sooner than Clinuvel has in the last 18 months since approval. But Clinuvel got stuck with the decree at market approval for a plan and then implementation of special education and monitoring (they all have monitoring) and audit and control of the distribution in addition to a normal Pusr or RMP before getting to price negotiate and sell.
It could be simple in that Clinuvel just takes what the Italians or Germans offer, then what do they do if this is not even enough to pay the bills for Clinuvel let alone give a tiny return on investment. W is having to do his homework and earn his pay at this pivotal moment and outcome of pricing that the stock price will react to, or not. He has to get the Italian pricing authorites to recognize this drug price can make or break this company stock, and it is very fair to pay at least $25,000 per implant when comparables to other drugs, such as Genzymes at $200,000 per year are evaluated with relativeness.
We better hope he gets at least $25,000 each. I do not know what will happen if they say no. Bottom line in my opinion, W has gotten the drug approved, he did it I think we all could agree at a very limited stock dilutions, even if you compare to other small drug companies I think no company has ever spent so little to get an EMA approval even for a none NME, and they spend even ten times what he has and do not even get approval (msh sister from U of Arizona Palatin is just one)
Epitan management raided the bank accounts of cash in salary and payouts after the FDA issued a letter that it would absolutely not approve a drug for tanning and there was no money and no hope till W stepped in. His management style is on a need to know basis and he has stated he wants to not give any help to the competition. W issues at least as many press releases and data as most all other ASX and Nasdaq. He just does not tell investors what they want to hear or embellish or accentuate or lie like many other self promoting drug managements that some are just frauds. I think if it were or is not his style and management this company would not even exist, let alone a drug approval. I think Clinuvel stock would be much higher if listed on Nasdaq. But I also think this is W strategy to keep any hostile takeover abay which is so easier to do in USA than the protections on ASX and we would probably have been sold out, merged, or taken over by some NY city slickers whom would have seen to it we got little. Who knows, maybe we are wiped out already with Valurix and do not even know it. Just like every company you cited happened too. And some Ceo' left with tens of millions. Only Intermune started its original drug and got it to approval befor selling out, but that I think had a lot more to do with the unusual circumstance of the startup of this company ceo had his own child with the orphan disorder for the very drug he was managing to get ma for.
On Saturday, May 7, 2016 at 4:17:39 PM UTC-7, MrPoonz1 wrote:
Fair comment.
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