Replies to post #329952 on Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

I’m sure you read the guidance for Covid:

III. PRE-IND PROCESS
During the current public health emergency, with the large number of potential therapeutics for COVID-19 related illness, it is essential that the review process for investigational drugs be as efficient as possible. To facilitate this, we are urging sponsors to submit a pre-IND meeting request that allows early and thorough review and discussion between the sponsor and FDA, which can lead to more rapid review of the subsequent IND and assurance of subject safety, which in turn can facilitate faster clinical trial initiation for programs that proceed to that phase. Given the range in clinical manifestations of COVID-19 and the large number of drugs and mechanisms of action being evaluated for use in this disease, the Center for Drug Evaluation and Research (CDER) has established a multispecialty, multidisciplinary team focused on review of drug development proposals.
We recommend that sponsors seek initial advice under pre-IND meeting requests.5 For the purposes of our response to the COVID-19 public health emergency, we are consolidating the typical pre-IND meeting request and package development process into a single step. For pre- IND requests for drugs that treat or prevent COVID-19, the content requests and processes described within this guidance substitute for those used in other settings, which FDA has described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017).




Etc.... if done right and quality data is given the turn around time will be much quicker than a normal pre-ind and ind process. I would not relate to previous trials. This is Covid.

[TheHound]

Thanks for the follow up! Consider this a formal no response.

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