It sure seems s that way @Diane325. ….
Q6: Can the CNPV be applied to a product at any stage of FDA review?
A6: Yes, the voucher can be applied to a product at any stage in development.
Imagine if the minutes of the meeting confirmed this for CHF and formed part of the detailed feedback and / or reduced ‘timelines’ for the BLA ? It would certainly be the cherry on top for a CHF partner
“The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing.”
GLTAH
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