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Strategies & Market Trends : Roger's 1998 Short Picks
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To: Hank who wrote (11572)7/16/1998 2:51:00 AM
From: Marconi  Read Replies (2) of 18691
 
Hello Hank:

With your long pharmaceutical experience, what is your opinion on the FDA approving Zonagen's drug if it is not statistically significant from placebo?

It is my understanding Japan approves based on safety (=no clear harm), Europe on safety and some effect, but the FDA approves NDA's on scientifically demonstrated results; suggesting to me approval is unlikely. It would have been foolish for Zonagen to present unscientific results to the urology convention, then submit to the FDA a body of data showing otherwise. I intend to short ZONA--but need to review some further assurances first, and perform diligence if there is anything at all with any prospects there. I take the urology material to mean FDA NDA approval will never happen. This discounts the notion that not submitting the NDA props the stock price--the NDA would make no difference. I had expected ZONA to tank after the urology meeting, but it didn't; this still bothers me.

Best regards,
m
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