but at the end of the day the FDA are happy with the efficacy
Premise absolutely not granted.
Krause saying the goods news the absence of negative comment is not the same as the FDA having no negative position.
Without seeing the CRL and without understanding the science to disambiguate ambiguous sentences into what they possibly could mean you are taking hearsay evidence as fact. You are trusting biased witness accounts. Put bluntly Krause failed. He stressed longevity data as being persuasive and it wasn't enough, it never could have been. You start with confounded data (a limited number of datapoints) and you keep only reporting on the continued success of your sucessful instances (the surviving patients) and you are forever not explaining why those one's in particular were successful (survived) versus the others.
2023 The Final Countdown, page-3312
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