What in the world are you talking about? CRL? Those happen with rejected applications. We haven't even applied yet. The whole point of the meeting is to find out what kind of application we should anticipate submitting and what the FDA expectations are for this prospective application. Apply for AA? Great! In exactly which patients/ circumstances? What will be needed for a confirmatory trial?
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- Ann: Meeting Requested with FDA on Revascor Accelerated Approval
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Ann: Meeting Requested with FDA on Revascor Accelerated Approval, page-123
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