Or, it's in preparation for covid approvalOk, let'

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Or, it's in preparation for covid approval

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Ok, let's play that out.

The FDA issues a RTF (Refuse to File) a week or so before we submit our P2 M/M results for COVID approval. I am assuming the DSMC won't stop the P3 S/C due to overwhelming efficacy, although that remains my hope.

The Type A Meeting is typically scheduled within 30 days AFTER the issuance of the RTF. The meeting doesn't happen within 30 days -- it is scheduled.

Ouch ... that's a problem, but there's more.

Then, after the Type A Meeting, there must be a re-submission that is based on the alignment of expectations reached during the meeting.

Then, if I am understanding correctly, the FDA has 2 months to respond to the re-submission.

So, all counted, that seems like 3+ months to me.

Doesn't seem like they are doing this in preparation for COVID approval -- unless their intention is to drag this out and give us COVID approval in November.