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Re: Hoskuld post# 437650

Tuesday, 10/31/2023 2:48:46 PM

Tuesday, October 31, 2023 2:48:46 PM

Post# of 517483
As far as I can find there are no fees for meetings with the FDA. There are fees for filing an NDA which as far as we know Anavex has not yet done.
Even so the NDA filing fee is waved for an NDA for an orphan drug. 2-73 has orphan drug designation for Rett so no NDA filing fee.

FY 2023 and FY 2024 User Fee Rates
Fee Category Fee Rates for FY 2023 Fee Rates for FY 2024
Application
Requiring clinical data $3,242,026 $4,048,695
Not requiring clinical data $1,621,013 $2,024,348
Program $393,933 $416,734



Designated Orphan Drug or Indication:

An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.


The real folly is ignoring the progress the company has made.

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