Replies to post #325936 on Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

Ok then why did Remdesivir perform the animal studies?

The answer is here

"The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) added a new section 565(d) of the FD&C Act to require that FDA establish a procedure for a sponsor or applicant developing “a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption” (IND and IDE, respectively) to request and receive two meetings with FDA – one meeting to discuss “proposed animal model development activities” and a second meeting prior to initiating pivotal animal studies. More MCM-related counterterrorism legislation"

https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-information

My interpetation of the above is the animal studies are required in stead of testing on normal human volunteers which obviously would not be ethical for Covid19 {besides the fact no one is likely to volunteer for these tests}.

So we are tip toeing around the same point.

Thebottom line is Remdesivir was required to perform animal testing but after the IND approval.

I expect Brilacidin will have the same requirement

GLTA Farrell

[loanranger]

"The FDA does not require animal studies for an IND approval unless there is a safety issue."

The origins of my point in raising the question were in the highlighted section of the following:

But your General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products says this, among other things, under the heading of General Nonclinical Considerations:
"For approved drugs, reference to FDA-approved labeling may suffice in some cases.FDA may exercise some flexibility in the types and amount of data necessary to support drug development for treatment or prevention of COVID-19, but for proposals to proceed — when involving unapproved drugs, new doses or formulations of an approved drug, or new routes of administration (e.g., inhalation) that have never been administered to humans — typically nonclinical in vivo data will be needed to determine the risks of the drugs and to support safe starting doses in humans."

The underlined section both supports and clarifies your statement:
The FDA does not require animal studies for an IND approval unless there is a safety issue AND the in vivo data will be needed to determine whether or not there is a safety issue.



Farrell responded with some facts:
"The Remdesivir IND for Covid19 was granted on 2/26/2020 without animal studies
THe Remdesivir animal study was reported on 4/17/2020"

and then he said this:
"Evidently the Covid19 emergency allowed the FDA to grant the Remdesivir IND without the animal studies normally required."

Obviously the urgency of the pandemic influenced the decision, but that's not likely to have been the only influence. I suspect the history of preclinical AND clinical testing of R's antiviral use...things that B can't show as far as I know (?)...supported the decision.
R had blocked the Ebola virus in Rhesus monkeys in 2015 and was subsequently used in humans. It didn't prove adequately effective in humans but "The trials, however, established its safety profile."
https://en.wikipedia.org/wiki/Remdesivir#cite_note-32


Now, as we used to say back in the neighborhood, let's you and him fight :o)