Brief: Dermata Therapeutics Says Received Correspondence From FDA On Submitted Waiver Request For Requirements To Complete 90-Day Dermal Toxicity Minipig Study

Dermata Therapeutics

02/03/2022 22:49

March 2 (Reuters) - Dermata Therapeutics Inc  DRMA.O :
    * DERMATA THERAPEUTICS - RECEIVED CORRESPONDENCE FROM FDA ON
SUBMITTED WAIVER REQUEST FOR REQUIREMENTS TO COMPLETE 90-DAY
DERMAL TOXICITY MINIPIG STUDY
    * DERMATA THERAPEUTICS INC - FDA HAS CONFIRMED CO SHOULD
COMPLETE
A 90-DAY DERMAL MINIPIG STUDY AND PK STUDY PRIOR TO INITIATING
PHASE 3 ACNE PROGRAM
    * DERMATA THERAPEUTICS INC - FDA AGREED WITH DOSING AND
TREATMENT
TIMELINE PROPOSED BY COMPANY FOR 90-DAY DERMAL MINIPIG STUDY
    * DERMATA THERAPEUTICS INC - COMPANY PLANS TO INITIATE
90-DAY
DERMAL MINIPIG STUDY IN FIRST HALF OF 2022
    * DERMATA THERAPEUTICS - CO PLANS TO REQUEST END OF PHASE 2
MEETING WITH FDA IN FIRST HALF OF 2023, BEGIN PHASE 3 ACNE
PROGRAM IN FIRST HALF OF 2023
    * DERMATA - NEED TO CONDUCT PHARMACOLOGY, SYSTEMIC TOXICITY
STUDIES MAY BE WAIVED IF CO CAN SHOW LIMITED SYSTEMIC EXPOSURE
OF DMT310 IN MINIPIG, PK STUDIES

Source: (https://bit.ly/3MgDcZg)
Further company coverage:  DRMA.O 

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