Replies to post #361436 on Innovation Pharmaceuticals Inc (IPIX)

[xoc]

 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention

This article above which I quote below contains recommendations about conduct and design of clinical trials on COVID from the FDA and explains why interim data analysis for efficacy will likely not be performed as “releasing interim results could have ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making.”

One can also see that our trial design appears to be following these recommendations for trial design and analysis to a T, hopefully facilitating EUA upon release of great results.

[olden_grumpini]

“What protocol do you suggest or expect them to break???”

I think a case can be made to unblind the data when subject 120 completes their study visit on Day 29 (earlier if the subject dies). I don’t think waiting until Day 60 for the follow-up phone call is required.

Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status.

This is what the literal interpretation leads to:
Subject 120 is Tatiana.
June 3rd — first dose of brilacidin or SOC
June 7th — 5th dose of brilacidin or SOC
July 1st — “Primary” endpoint and 21 of the 22 “Secondary” and “Other” endpoints met
Now the world sits and waits until August 1st for someone to pick up the telephone and call Tatiana to ask her, “Tatiana, how are things going?” (sorry, don’t know the Russian).

Tatiana is the LAST subject. 119 subjects have been dosed (per loanranger’s recap):
March 5th — 15 subjects dosed
April 5th — 30 subjects dosed
April 28th — 60 subjects dosed (“randomized” is the term in loanranger’s post)
May 13th — 84 subjects dosed
June 3rd — 120 subjects dosed

It strains credibility that the FDA would endorse holding up everything for the extra 30 days. I suspect the 60 day follow-up was put in during the trial design when IPIX assumed it would recruit quickly, rather than being spread out over 4 months. The DMC has been keeping track of the subjects who completed their treatments and would have data on TRAEs at day 60 if needed.