Brief: Xspray Pharma Announces Positive FDA Meeting, Plans For Dasynoc NDA Resubmission

Xspray Pharma publ AB

19/09/2024 07:39

Sept 19 (Reuters) - XSpray Pharma AB (publ)  XSPRAY.ST :
    * ANNOUNCES POSITIVE FDA MEETING AND PLANS FOR DASYNOC NDA
RESUBMISSION
    * COMPANY PLANS TO RESUBMIT ITS NEW DRUG APPLICATION (NDA)
FOR
DASYNOC IN Q4 2024, INCORPORATING FEEDBACK FROM COMPLETE
RESPONSE LETTER (CRL) ISSUED BY FDA IN JULY 2024
    * IF FDA SETS A TWO-MONTH REVIEW PERIOD UPON RESUBMISSION,
LAUNCH
OF DASYNOC COULD BE EXPECTED AS EARLY AS Q1 2025

Source text for Eikon:  ID:nMFN8X2Mfc 
Further company coverage:  XSPRAY.ST 

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