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Biotech / Medical : biotech binary events -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (71)	8/10/2003 7:41:42 AM
From: Icebrg	Read Replies (1) \| Respond to of 295

Rick I believe we all agree with respect to most of your criticism. The interesting question is however why the current trial is taking so long time to conclude. It seems to be fairly well-established that a patient population of the type that normally would be included in this type of trial has a life expectancy of 8 - 10 months. Some will live longer and some will die almost immediately. But a median survival time of 8-10 months is perfectly in line with what could be expected. And if that is indeed the status of the people recruited into this trial, then it will turn out to be successful. (Based on what we already know). There remains however the possibility that the patients recruited into the trial were indeed "healthier" than what could be expected. The company has taken some steps which indicate that they may also think (or fear), that this is the case. - They increased the number of participants slightly (from 280 to 302, I think it was. Perhaps they lost Argentina due to the political turmoil in that country). - They raised the number of patients who should have passed away, before the blind was broken. I may be mistaken here but I think they went from 200 (which appears as a very aggressive and early target considering that each group had 150 participants) to 230 which should put them on safer ground. Another factor that might indicate that the population participating in the study might be difficult to "control" is that is is very widely spread over a number of different countries. Recruitment standards may well vary in a way that influences the patient population. Argentina: 2 sites. Belgium. 1 site. Candada: 7 sites (only) Czech Republic: 2 sites (Olomouc and Hradec Kralove)! France: 15 sites. Germany: 7 sites. Poland: 1 site (Krakow) UK: 4 sites USA: 4 sites. (By and large this is almost an European trial) On the other hand, these trials have a very uncommon design and one has to ask, who would like to participate. The placebo group don't receive any medical treatment whatsoever. The are just there to die and be counted. And the Neovastat group doesn't have much better prospect. Under normal circumstances a trial participant with progressive disease would be taken off the trial. In order to make it possible to try something else, I guess. But in the Neovastat trial they are just left to their fate. Until they can also be counted. With this type of design it is difficult to believe that any patient with still some hope for survival would agree to participate. They would try something more human. Although the number of possibilities for metastatic and refractory patients appears to be very limited. But still, it is hard to believe that patients recruited into this trial were in the very best condition. Even if they believed strongly in the healing powers of shark cartilage extracts, there would be a 50 % chance that they would just be getting placebo. Very bad odds considering the general odds for this condition. So, I think the question is still open: Why does this trial take so long time to finish. ZENTARIS on the other hand seems like a very interesting proposition. There you will find a number of interesting drug candidates, solid German science (they used to be a part of Degussa) and a couple of drugs which are already on the market. Miltefosine may not enrich AEterna's shareholders, but well the millions of poor people around the world suffering from leishmaniasis (black fever). As for their second sub-division Atrium. It is supposed to be profitable, but with a 61 % ownership AEterna will not be able to enjoy the pleasures of its positive cash-flow. Sooner or later they will sell or float Atrium and hopefully be able to collect their dues. (Which they will no doubt sink into some new development project). Erik