$Fgen
Just to summarize a bit, ZIP said he's being told the exclusion of PYRENEES was "directed by the FDA". Awaiting where he got this information from, but others have cited a screenshot from Bloomberg referencing Astra responding to this. Just to clarify, that screenshot says the pooling was "agreed" with the FDA.
Maybe I'm splitting hairs, but by the time this gets to AdCom/Review there could be a material difference between "agreed with FDA" and "directed by FDA".
Agree w/ dewohpile, it wouldn't be hard to say come out with a PR stating WHY it was excluded and that it was directed by, or agreed to with, the FDA.
Rhetorical question: is all this a canary in the coal mine or is it a buying opp afforded by corporate incompetence?
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