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Biotech / Medical : Zonagen (zona) - good buy?

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To: Bruce Rosen who wrote (270)5/22/1997 2:11:00 AM
From: Jonathan Rothschild   of 7041
 
The company is doing the right thing by having the third party take their time in analyzing the results. The way the results are analyzed are almost as important as the results themselves.They are being extra careful because they know they will have to defend their statistical methodology to the FDA. Delays are no indication (positive or negative). Of course, the suspense is killing all of us. IMHO, if the results were nowhere near achieving statistical significance, we would have heard by now. I was a little concerned that they were looking for a 50% threshold for statistical significance, as this is a very difficult endpoint to accomplish (30% placebo rate in all e.d.treatments). I assume that the unblinded trials, which the famous urologists based their comments on, were based on similar endpoints.They refined their study based on the ear;y phase 2 data. This is the way clinical studies should be performed and make more sense than rushing into phase 3 without learning anything from previous problems..
Since this is a high stakes gamble, some investors are getting out of their positions in advance of the meeting. I also think the shorts jumped on it today when the stock price stalled, hoping to draw in more selling. Those who have already established and maintained a long position, are sophisticated investors who can withstand the day to day fluctuations in advance of the meeting. Some are actually accumulating on weakness. This is typical with any event-driven position, especially when they are no options with which one can hedge.
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