Replies to post #250304 on Innovation Pharmaceuticals Inc (IPIX)

[Rdunn88]

Wouldn't the FDA want a large P3 since IPIX changed the delivery system from "swish and spit" to sachets?. Exactly why a new manufacturer was hired... The FDA may have found reasons for IPIX to change methods? Who knows, but without a partner it's all irrelevant.

[KMBJN]

Was at an ethical research conference a couple of weeks ago and went to a session on national right to try laws. A gentleman from the FDA spoke on FDA compassionate use policies. Someone else spoke on the legal specifics of national right to try with respect to state right to try laws and FDA compassionate use, and the difference between them. Someone from BP also spoke on the panel.

Anyways, it turns out that nobody is using the national right to try laws. Not one instance that anybody there was aware of.

The FDA's compassionate use program approves something like 98 or 99% of requested compassionate use requests. It's not FDA per se keeping people from drugs. FDA sees their job as keeping people from being harmed.

Drug manufacturers are not required to provide drug to people who request it. There are serious considerations for drug development if they do that, but many do provide compassionate use outside of trials anyways. Drug manufacturers try to get the drugs to the most people as quickly as possible, and most feel the best way to do that is through the formal FDA process.

There have been only 1 or 2 instances of compassionate use protocols being used as the sole basis for NDA approval.

The right to try law is simply the right to ask law, and won't make much difference to the availability of safe and effective drugs.

It's good that FDA is trying to streamline things somewhat, and to provide incentives on the most promising drugs to progress quickly.