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sunspotter

06/23/21 10:13 AM

#363406 RE: Hugon #363402

"i wonder if ipix helped any patients using the compassionate use program over the last year?"

I doubt it. I think I've written here before that compassionate use (CU) programs are fraught with danger for any pharma company, IPIX included.

It's basically a no-win situation for the company and drug involved.

Almost by definition the recipients of a CU drug are at death's door, so the chances are they will die. When that happens the drug gets a bad name because it "failed" and it's almost impossible to pull back from that.

Even if it works then that could be ascribed as being due to chance.

On this basis it's much better to evaluate a product in a controlled Phase II study , then once you have at least some data that the product works and has a reasonable risk/benefit profile you can allow CU.

Even then it's still risky because it's used in the most hopeless cases.

I don't blame IPIX for not making brilacidin available for compassionate use.

Snowy_Owl

06/23/21 1:40 PM

#363438 RE: Hugon #363402

Compassionate use can be a double edged sword.

A quick FDA approval with an immunity from liability would much better. I suspect the liability aspect is reserved for the big dogs.

There’s been a lot of dollar projection if B for C is efficacious.

I’m curious about potential off label market potential for other viruses. Whoever is selling B cannot legally recommend off label prescribing but the word gets out.