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

To: Peter Kerling who wrote (5383)8/27/1998 4:34:00 PM
From: biodoc  Read Replies (1) | Respond to of 7041
 
I'll answer too--they have 60 days to have a refusal to file (i.e., not accept the submission] I think, but am not sure, that comes on Sept 12 (which is before Sept option expiration date).



To: Peter Kerling who wrote (5383)8/27/1998 5:15:00 PM
From: Tokyo VD  Read Replies (1) | Respond to of 7041
 
Peter,

The FDA has a 60-day period to "accept" an NDA. If the FDA does not correspond with Zonagen, then the application is considered effective. The "clock" began on approximately July 15th (the date which Zonagen publicly announced its NDA filing).

Assuming the FDA accepts the filing, then the FDA reviewers will continue their analysis of the data. The FDA strives to review all NDA submission within a 12-18 month time period.

Tokyo


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