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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: biodoc who wrote (5438)9/2/1998 10:19:00 PM
From: Linda Kaplan  Read Replies (2) | Respond to of 7041
 
One good thing for the shorts is that even if the application is accepted for processing, the wait is a year, and the drug can be not approved after all that long wait. So for the longs, the money is dead for that year, with risk of non-approval. Who wants to be long a company in that uncertain situation, with a possible bear market looming?

As for the discussion, I assume they must mail on the 60th day, and that the company would not announce till after receiving the letter, so it could even be till Sept 18th that an announcemnt might be made of non-acceptance of the application or requests for more trials.

Linda



To: biodoc who wrote (5438)9/3/1998 1:18:00 PM
From: Claud B  Read Replies (1) | Respond to of 7041
 
In the case of Aviron, the 60-day period WAS adhered to. Notice
that the company or whomever, listed the submittal date as June 30.
The FDA goes by the day they receive the application. Companies
who submit an NDA get a receipt from the FDA. in Aviron's case
their NDA was probably not received until July 2, or so.

All this is just for clarification purposes regarding this 60-day
rule.

As for Zonagen, the 60 day period expires September 13.

Claud


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