I have also lightened up. Additionally I wonder: was this the only route, a CRL, when an accelerated approval subject to a conditional approval is the consensus: that is do FDA ever issue a full blown "Approval" conditional to further data required? given this was agreed(?) upon in odac meeting, perhaps a CRL was technically the only step forward. Just a thought as I am unable to find info on this.
MSB Trading 2020 - a new dawn, page-8109
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