Having been on the wrong side of an FDA CRL a couple of times I can say without doubt it's not fun. But both times they were small biotechs with products that appeared to be guaranteed approval but were in a space already occupied by large pharma.
Not the case here. Hard to imagine soft tissue not getting approval and with no negative comments from FDA same should be true with vitiligo.
SP if both FDA approvals go through, page-56
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