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Biotech / Medical : Zonagen (zona) - good buy?
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To: Tokyo VD who wrote (5198)8/11/1998 6:19:00 PM
From: Dauntless  Read Replies (1) of 7041
 
Tokyo - more clarification

It is my understanding that Zonagen (if not all companies) reviewed their results with the FDA after each phase of their IND. They also reviewed and modified, as necessary, their plan for the next phase. Implied in this is that the FDA was satisfied with their phase 1 and 2 results. Of course I never meant that the phase 3 was accepted as that's part of what we're all waiting for.

You say there are a lot of cases where the company believes they will get approval - I agree - given the vast amount of work that goes into a filing (Zonagen's was around 400 3 inch binders) 100% of them must expect approval. The FDA's statistics imply that 67% to 80% of drugs that complete phase 3 are approved. With SGP intimately involved in the submission and with their experience in this sort of thing, I believe that they have at least as good, and certainly no worse, a probability for success than the above numbers indicate.

TXB was another type of situation. Their study was run against historical controls, a methodology which I am told is MUCH more difficult. TXB's problem was that the control group did not match up well against the prospective group. They are collecting additional historical data - note that they aren't doing any more live patients - and they will resubmit - a delay, but not the end of the world.

Good luck with your investments.
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