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Re: apollo1452 post# 2635

Monday, 01/16/2017 4:48:29 PM

Monday, January 16, 2017 4:48:29 PM

Post# of 7747
This is what I just posted on YMB which I freely admit is purely conjecture:

The guidelines indicate that a Type B meeting will be scheduled within 60 days from receipt of request, not 60 days from granting the meeting. Unfortunately, we don't know when the meeting was requested. The updated results were announced on November 29, so obviously the request was not made before that date. The announcement that a meeting had been scheduled was on January 4. So the literal timeframe would be between those two dates. Realistically, a request was not made immediately on November 29--one would have to assume that there was time needed to prepare the request. On the other hand, it does not seem plausible that the request was made after the 1st of the year--FDA would need time to evaluate the request. So, I'm guessing that the request was made sometime in the 2nd and 3rd weeks of December (12-23). If this is the case, the meeting (based on the 60 day timeframe) should take place between February 9 and February 23. Of course nothing states that the time has to be 60 days, only that it must be within 60 days. So the meeting certainly could occur before February 9. I have seen some opinion that it will be on February 1 which I certainly hope is true.