Why Would The FDA Give MNKD a Favorable Plant Inspection..........(i.e. Tyvaso DPI) | MNKD Message Board Posts


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Msg  17674 of 17696  at  10/4/2021 12:40:39 PM  by

tocentsworth

The following message was updated on 10/5/2021 10:08:16 AM.

Why Would The FDA Give MNKD a Favorable Plant Inspection..........(i.e. Tyvaso DPI)

if it intended to issue a Complete Response Letter to UTHR just before the PDUFA date? Also, if the FDA's agreed upon protocol and end points were reached in the BREEZE trial, why would the FDA refuse Tyvaso DPI marketing approval around the PDUFA date this month?
 
 
 


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