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Biotech / Medical : Zonagen (zona) - good buy?
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To: Bill Wexler who wrote (4075)5/11/1998 5:32:00 PM
From: Tokyo VD  Read Replies (1) of 7041
 
Bill,

Some people I know thought that Novastan was approvable. I guess this is one of those cases where a company that finished its Phase III studies with statistically significant endpoints didn't receive FDA approval (somebody in this forum posted the approvable outcome ratio from the FDA site where companies that hit its primary endpoint received FDA approval--was it +80%?)

TXB initiated its NDA filing in July, 1997, announced SKB as partner in August, 1997, received expedited review status from FDA in September, 1997, and received the deficiency letter in May, 1998 (10 months later).

My question is that if this drug took 10 months to review (with FDA expedited review), how long will the FDA review take if Zonagen files in June?

Tokyo
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