Replies to post #338495 on Innovation Pharmaceuticals Inc (IPIX)

[Empiricst1]

Just my opinion, FDA likes to have more than one site to diversify the treatment group, lessening the chances for findings not reflective of the overall population. But recall that the 120 is only for a P 2. We can expect hundreds more for the P 3 to be required. Others posting here have shown examples of much less than the tens of thousands required of P 3s for vaccines, being required for non-vaccine studies. Glad for that, as it readjusted my (our) beliefs, making them more accurate.

[farrell90]

Good point. Earlier in the fall when the trials were being planned the Covid numbers were fluctuating at different geographic sites. Unfortunately the numbers of Covid cases now seems to be increasing everywhere,here and abroad.

My guess is the geographic diversity of the sites was to protect from a down turn in the number of cases at several sites which would impact the number of cases eligible for study.

In retrospect it appears that precaution is proving to be unnecessary.

The increase in the number of cases does reinforce the need for better treatments and a better antiviral.

Hopefully Brilacidin will be effective.

GLTA,Farrell

[Rdunn88]

Overseas trials to broaden revenue possibilities but since they have yet to have the application approved I’m sure Leo could shift plans to only USA. No time to waste.....

[kfcyahoo]

"Serious question to anyone, with only 120 patients needed for this trial, why is there a need to spread it out over multiple sites including overseas! Wouldn’t it be much easier and quicker to focus on just a couple sites given that there is so many patients everywhere!"

I think only the ceo can answer that question. Galera has a phase 2, 50 patient covid trial(intiated on 9/9/20) for their drug GC4419(same drug in OM trials) at 2 trial sites. CT lists primary completion date November 2021 and study completion date as December 2021.

https://clinicaltrials.gov/ct2/show/NCT04555096?term=galera&cond=Covid19&draw=2&rank=1