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Re: A deleted message

Wednesday, 03/12/2025 10:02:36 AM

Wednesday, March 12, 2025 10:02:36 AM

Post# of 257382
Nitpick:

PDUFA Date of Jan 2028 (10 months is normal)

The standard review time is 12 months for an original (rather than a supplemental) NDA—2 months to accept the submission for filing and 10 months for the actual review.

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