I still don't understand why we didn't get EUA, as a minium- unmet need and people and kids are dying- its safe so why not EUA, the FDA can monitor progress and call it off if any issue. ...what will the FDA do with those other approvals that will cause harm to people if not death!!
there have been approvals base on much lesser data of late via FDA which we all know make no sense.
in the mix was those secondary endpoints- which were huge in saving lives- other approval have been had on secondaries.
FY22 - It's all to play for here!, page-37
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