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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?


To: DELT1970 who wrote (3541)12/16/1999 12:59:00 PM
From: Joe  Respond to of 4140
 
Delt, I'm still on vacation. Regarding approval, it often takes 60 days or more. One of the things FDA has to do is a GMP inspection of the Sunrise manufacturing facility. It is possible that this has already been done, but I have not heard that it has been done.

Since this is SNRS's second trip to Panel, my gut feeling is that it will take less rather than more time for them to act since the labeling has already gone through one level of massaging to get back to Panel.

So 2 to 4 months is my guess, and I am leaning toward 2 months.

Joe