Replies to post #331882 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"If anyone looks at the May 2020 FDA document IPIX referenced in their PR, the FDA would have to grant an exception to start sooner then 30 days."

That's true.
Did I say something that led you you to think you needed to tell me that? There was nothing in the post you responded to that suggested otherwise, was there?

I provided the relevant section of the Code of Federal Regulations earlier...it's a more definitive source than the IPIX Annual Report, which makes no mention of the potential of an earlier notification:

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.

https://www.ecfr.gov/cgi-bin/text-idx?SID=442b73a0f995aebee810a4c4d2f6fc59&mc=true&node=se21.5.312_140&rgn=div8
"e-CFR data is current as of November 5, 2020"



Now, if we only knew when the IND submission was or will be sent we'd have a better idea of when the trial might really start.
Of course the law only describes the point in time at which a trial MAY start. The Company needs to do a lot of work ahead of when the trial CAN start. The IND submission date won't tell us the status of the latter.