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seekinganswers

09/09/25 3:30 PM

#787360 RE: barnstormer #787359

OS results based on phony external controls that didn't match the trial cohort, and POST HOC no less? (were never in the trial design)
Oh and then there was the crossover disaster and failed PFS to consider..
Good Luck.
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skitahoe

09/09/25 3:31 PM

#787361 RE: barnstormer #787359

Barnstormer, in reality the gold standard is overall survival, PFS is a faster and cheaper way of potentially gaining approvals. In some cases after approval the FDA found that patients weren't actually living longer, but other benefits kept the products on the market. Quality of life is a valid reason to approve a product as well and some of the newer products do offer higher quality even if patients aren't living longer.

Our vaccine has practically no negative side effects, if certain treatment isn't required with it, the quality of life may be substantially better when it's used.

Gary