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Re: corpstrat post# 3369

Thursday, 02/21/2008 7:12:05 AM

Thursday, February 21, 2008 7:12:05 AM

Post# of 8473
I took a rather large out of the money call position around the last IND filing/acceptance. I checked with several people and was informed (correctly or incorrectly) that the IND process was one of giving the FDA 30 days from the time of filing and if there's no word back it is almost like a "de facto" acceptance.

In this case it's not that the FDA is doing anything to wait until the last minute, even Joe told me that sometimes companies never hear "boo" back from the FDA on an IND filing. They just wait 30 days and can assume with almost certainty that there's no issues at all and then begin trials.

I doubt Joe, after having a pre-(anemia) IND meeting with the FDA, and also having proellex begun two human trials, also with IND (do both the Fibroids and Endo have an open IND ???- good question for docbanker) will hear anything back, but he's got to wait probably 33-34 days to be safe before making an annoucement. Announce that the IND "goes live" on day 30 and then have the FDA say "wait a minute Joe" would be way worse than giving them a few days wiggle room, IMO.
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