" I would not relate to previous trials. This is Covid. " I didn't. I know.
"if done right and quality data is given the turn around time will be much quicker than a normal pre-ind and ind process." They changed the process to expedite it, but they didn't change the law.
PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION
Subpart C--Administrative Actions
Sec. 312.40 General requirements for use of an investigational new drug in a clinical investigation. (b) An IND goes into effect:
(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under 312.42; or
(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.
The nitty gritty of the PROCESS is obviously relevant and complex, but the above is as clear as a bell and plenty fast. If you know when the Company files its IND you also know that within 30 days from that date THE COMPANY will know that they can go forward with their P2 B-CoVid trial or, if not, why not. The Company has not announced whether or not they've made their IND submission so obviously, if they have, they haven't announced the date of the submission.
A journey of a thousand miles begins with a single step and the IND submission is that first step. One would hope that the Company thinks it's worthy of an announcement, but the B-OM example provided earlier showed that they didn't think that way in 2014. Have they changed?
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