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Re: JonAnon post# 375398

Thursday, 09/23/2021 10:18:25 AM

Thursday, September 23, 2021 10:18:25 AM

Post# of 403096
"I suppose the FDA is being paid off to help with the fluff PRs for Leo's pocket? The physician, hospital board and many others are getting piece too? They must really be making money on the compassionate use delivery although it doesn't create revenue."

I don't suppose any of those things.

You're missing my point, so let me explain it again.

Most every investigational drug has patients and doctors clamouring for it when they're in extremis. The risk/benefit ratio is pretty good if the chances are you're going to die anyway. FDA rarely object to expanded access unless they think the company is trying to bypass the normal regulatory route (which happens more often than you might think).

But the companies that are developing the drug most always say no, sorry, but no, particularly when it's a Phase II asset.

Not because they don't think it will work, but because they don't want the reputational risk that goes with perceived failure given that many of these patients are going to die anyway (hence the reason that that group of pattients were explicitly excluded from the brilacidin trial).

I've seen institutions/hospitals/doctors refuse to use drugs when they become approved because of bad experiences with compassionate use.

That IPIX have ignored this calculus means they're not worried about that reputational damage, but that they did want something nice to say in today's PR to offset the announcement that the trial results won't be available until later than most (not all) folk thought.

It always pays to wonder why and to follow the money when OTC penny stock CEOs do unexpected things.

"Nobody ever went broke underestimating the intelligence of the
American public."


H. L. Mencken

"It’s easier to fool people than to convince them that they have been fooled."

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