Brief: MaaT Pharma Says FDA Maintains Clinical Hold On MaaT013 In U.S.

Maat Pharma SA

10/08/2022 17:06

Aug 10 (Reuters) - MAAT PHARMA SA  MAAT.PA :
    * MAAT PHARMA ANNOUNCES UPDATE ON U.S. FDA INVESTIGATIONAL
NEW
DRUG APPLICATION FOR MAAT013 IN PATIENTS WITH ACUTE
GRAFT-VERSUS-HOST DISEASE
    * A RESPONSE LETTER INDICATES THAT AGENCY MAINTAINS CLINICAL
HOLD
ON MAAT013 IN U.S. AND DETAILS FDA'S POSITION ON CLINICAL TRIAL
    * AGENCY ACKNOWLEDGED THAT IT RECEIVED SATISFACTORY ANSWERS
FROM
COMPANY ON MULTIPLE CLINICAL AND MANUFACTURING-RELATED QUESTIONS
THAT AGENCY HAD INITIALLY RAISED
    * AGENCY REQUIRES ADDITIONAL INFORMATION, NOTABLY REGARDING
SAFETY
AND EFFICACY OF COMPANY'S "POOLING" APPROACH
    * COMPANY IS ALSO EVALUATING ADDITIONAL RECOMMENDATIONS MADE
BY
AGENCY REGARDING TRIAL DESIGN

Source text for Eikon:  ID:nBw96YMCra 
Further company coverage:  MAAT.PA 

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