Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

The failure to acknowledge your reference to B-OM (even though there was no reference to 2014) exhibited some senility on my part.

How do you explain how you "personally believe the IND was submitted weeks ago and our 30 days is near" on 10/27 when the Company hadn't "submitted a pre-IND meeting request to the FDA" until the week of October 2?

"Weeks ago" would have been 10/14 at the latest.

Was there time for the....
1. FDA to respond to the pre-IND meeting request.
2. The meeting to have been conducted.
3. The Company to have prepared and submitted the IND incorporating the meeting results
....between the week of 10/2 and 10/14?

Does your 2014 B-OM example address that in any way? Or was that just an example of how the Company had failed to provide timely disclosure at that time, so there's no reason to expect them to provide full, timely disclosure about their IND submission this time?

I think that the only reason for the Company NOT to announce the IND submission in real time is to avoid having to explain why the trial isn't starting 30 days after that submission date, should that occur. Can you think of another good reason?

The "approval" rule is a simple default. Basically it's "If we don't tell you that you can't ("clinical hold") within 30 days from the submission date, you can proceed with your clinical trial. We MAY advise you prior to 30 days that you may proceed."

If the submission is not announced in real time any approval prior to the 30 day point could be announced if and when it occurred. Would the same be true if there was a clinical hold?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.42