You don't have the OS nor did they have PFS. I don't believe there was a determination of futility and I can't argue and won't argue a point for which there are no facts.
The FDA wouldn't have the OS. It's not relevant. And I won't argue with straw men.
You can't sell a drug, under compassionate use or any other allowed marketing process, if the regulators have determined that use of it is FUTILE for that disease. Besides, they'd have had to have let us know that there was a futility determination. The notion that they would not have, wouldn't have stood. Regulatory agencies are not the NSA. It would have leaked out. We're talking global regulatory agencies with a duty to protect their citizens from exploitation from the very kind of activity that people are alleging as if it's normal, just to make a nonsensical argument.
These circular arguments around no facts about nothing only do one thing, create false controversy that misleads people about the status of a drug. I don't know that the drug will be approved, but I do know that no one likely knows the results yet. The notion that the regulators did the halt for futility, but allowed for people to cross over de novo, or do humanitarian use, or do the hospital exemption, despite that determination is simple nonsense.
I believe it actually might be disturbing for deathly ill patients to discontinue a treatment, in the middle of a treatment if it's not unsafe, so that is a kind of compassion. However, for those arguing that the treatment was determined SECRETLY to be futile, I think it's rather more on the point for them to show exactly similar cases of official sales, blessed by regulatory agencies, humanitarian or otherwise, of drugs that have never been approved for any other condition, that were found to be futile for the disease in question, and where such drugs continued to be administered to NEW patients who did not receive it before the determination, and where regulators allowed a company to charge for that treatment. I doubt you'll find cases in modern, civilized parts of the world where that is the case, maybe somewhere on the back streets. However, even if you do find an exception, and one can never bet against naysayers finding some exception out there, I'm sure we'll have to analyze all of the critical details, not just those presented by the poster.
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