They definitely need to inform the company that news is pending so trading halt can be arranged. They make announcements for all drug approvals (after trading halt is initiated) but it isn't clear whether they always allow the company to make the announcement first, or whether they sometimes are the first ones to announce. We definitely know they sometimes let the company announce first, as this is what just happened with ETON.
FDA never makes an announcement for a CRL, only for an approval.
MESO action tonight, page-2908
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