Brief: Acelrx Pharmaceuticals Inc - FDA Determined That Review Of Niyad Eua Is Not A Priority And Has Therefore Declined To Issue An Eua For Niyad

Talphera

22/09/2023 22:52

AcelRx Pharmaceuticals Inc  ACRX.O :
    * ACELRX PHARMACEUTICALS INC - FDA DETERMINED THAT REVIEW OF
NIYAD
EUA IS NOT A PRIORITY AND HAS THEREFORE  DECLINED TO ISSUE AN
EUA FOR NIYAD
    * ACELRX PHARMACEUTICALS INC - FDA ENCOURAGED CO TO CONTINUE
TO
ASSESS CLINICAL DEVELOPMENT OF THE NIYAD DEVICE
    * ACELRX PHARMACEUTICALS INC - PLANS TO INITIATE
REGISTRATIONAL
STUDY OF NIYAD LATER THIS YEAR, ANTICIPATES SUBMITTING PMA FOR
NIYAD TO THE FDA IN 2024

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Further company coverage:  ACRX.O