The crux of the matter for the panel was whether the Guillain-Barre risk warrants another pre-approval trial or whether a post-approval trial, which PFE has consented to run, is sufficient.
PFE’s PDUFA date is 5/31/23.
VRBPAC debates GSK’s RSV vaccine tomorrow. (GSK has a PDUFA date of 5/3/23.)
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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