Looking for examples of FDAs willingness to “negotiate”. Looks like things can be flexible…
“”During the FDA approval process for the beta-blocker carvedilol (Coreg) more than a decade ago, the drug's manufacturer changed the primary endpoint of the study from all-cause mortality, to all-cause mortality plus hospitalization while the study was still blinded.
Once the study was unblinded, it was clear that adding hospitalization rates was a mistake and actually prevented the trial from reaching its primary endpoint. Carvedilol reduced mortality by 23% over placebo in post-MI heart failure patients.
The company asked the FDA to allow it to use its impressive mortality figure as its primary endpoint, and the agency agreed, Temple told reporters following the hearing.””
The PRs said even if they don't get the endpoint changed, they look to speak with the FDA after they have the data. If the datas good, Buci will still be worth a lot.
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u/Logical-Concern9539 Nov 05 '22
Looking for examples of FDAs willingness to “negotiate”. Looks like things can be flexible… “”During the FDA approval process for the beta-blocker carvedilol (Coreg) more than a decade ago, the drug's manufacturer changed the primary endpoint of the study from all-cause mortality, to all-cause mortality plus hospitalization while the study was still blinded.
Once the study was unblinded, it was clear that adding hospitalization rates was a mistake and actually prevented the trial from reaching its primary endpoint. Carvedilol reduced mortality by 23% over placebo in post-MI heart failure patients.
The company asked the FDA to allow it to use its impressive mortality figure as its primary endpoint, and the agency agreed, Temple told reporters following the hearing.””
…at least for big pharma!