[the FDA] were concerned that they did not have another Thalidolmide on their hands.
Impossible as the FDA conceded early on that stage 1 of clinical trials was redundant as no material detrimental threat to patient and also the size of patient cohorts significantly reduced. This was inevitable and obvious as a development.
TBH I've worked in government and am all too familiar with the attempts to make themselves look authoritative when they have next to NFI. I cannot say more on such patterns of behaviour, but I've mentioned this early on and it's been verified in here in the last few days. Trump is about (relatively speaking) more recent events and it's all about opportunism and changing the culture.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-934
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