Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

Good point about the animal trials. At this point Remdesivir remains an unapproved drug. Remdesivir's IND was granted without animal trials. Gilead was allowed to perform the Remdesivir Covid19 animal trials concurrently with their initial human trials.

Evidently the Covid19 emergency allowed the FDA to grant the Remdesivir IND without the animal studies normally required.

The Remdesivir IND for Covid19 was granted on 2/26/2020 without animal studies

THe Remdesivir animal study was reported on 4/17/2020
while the initial USA adaptive human clinical trial was reported on 4/27/2020. An earlier Remdesivir clinical trial was initiated in China but was not completed.

The Remdesivir EUA was granted on 5/1/2020

My expectation is Brilacidin will also be granted an IND without completing Covid19 animal trials, but animal trials will be required before it is approved as a new drug.

We will see what the FDA decides soon.

GLTA ,Farrell

https://www.nih.gov/news-events/news-releases/antiviral-remdesivir-prevents-disease-progression-monkeys-covid-19

https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19

https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19