Brief: Aequus Receives Positive FDA Regulatory Guidance For Anti-Nausea Patch

Aequus Pharmaceuticals

03/05/2018 13:48

May 3 (Reuters) - Aequus Pharmaceuticals Inc  AQS.V :
    * AEQUUS RECEIVES POSITIVE FDA REGULATORY GUIDANCE FOR
ANTI-NAUSEA
PATCH
    * AEQUUS PHARMACEUTICALS INC - FDA HAS CONFIRMED THAT AN
ABBREVIATED 505(B)(2) REGULATORY PATHWAY WOULD BE APPROPRIATE
FOR SUBMISSION OF AQS1303
    * AEQUUS PHARMACEUTICALS - FDA INDICATED BIOEQUIVALENCE
STUDY TO
BRIDGE ORAL DICLEGIS(®) SAFETY AND EFFICACY DATA WITH AQS1303 IS
LIKELY ACCEPTABLE
    * AEQUUS PHARMACEUTICALS INC - FDA HAS AGREED WITH AEQUUS'
PROPOSED CLINICAL PLAN FOR AQS1303
    * AEQUUS PHARMACEUTICALS-RECEIVED POSITIVE FEEDBACK FROM
U.S. FDA
ON ITS PRE-IND SUBMISSION FOR CO'S LONG-ACTING ANTI-NAUSEA
TRANSDERMAL PATCH, AQS1303

Source text for Eikon:  ID:nGNXkFYBq 
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