Sixty days after the submittal on Nov 5th would mean the FDA's deadline would be Tues, Jan 4. Given that many federal employees take off the week between Christmas and New Years (especially executive mgmt who would have to sign off on the response), they could wait until the last minute and respond on Jan 3 or 4, but my guess is they will respond no later than the week before Christmas because most people who are going on PTO will try to clear their desks first. And they can respond any time during the 60 day period, but knowing how the fed moves at a glacial pace, I'm not expecting anything before mid-Dec.
Quote:
NP said on the Proactive video of Friday the 5th that it had already been submitted, and would be PRed the 8th.
No matter. The 60 days is just the max, not the predicted time of reply.