Novavax says COVID-19 vaccine BLA approvable; FDA requests additional clinical data as PMC

NOVAVAX INC

Believes BLA is approvable based on FDA conversations as of PDUFA date April 1 and through April 23.
Received formal FDA information request for a post-marketing commitment (PMC) to generate additional clinical data.
Intends to engage expeditiously with FDA to address the PMC and move to approval as soon as possible.

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