Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

My point was this statement: “Evidently the Covid19 emergency allowed the FDA to grant the Remdesivir IND without the animal studies normally required.”

The FDA does not require animal studies for an IND approval unless there is a safety issue. There only need be a theoretical argument of probable higher efficacy if safety and minimal efficacy is already well-established.

The advantage of simultaneous animal studies is the ability to perform tests that cannot be performed on human subjects. That part of an agreement would have been designed into the IND submission for SARS-CoV-2 testing.