Dermata: Type C Meeting Response from FDA, Submits DMT310 End of Phase 2 Meeting Package

 FDA agrees that Dermata's CMC procedures and controls support the initiation of Phase 3 studies-

- Dermata also submitted an end of phase 2 meeting package to the FDA -

 Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced that it has received a response from the U.S. Food and Drug Administration ("FDA") to the Company's Type C Chemistry, Manufacturing, and Controls ("CMC") meeting request. The FDA's response stated that the Company has provided documentation of its CMC procedures and controls sufficient to support the initiation of Phase 3 studies. The Company has also submitted an end of phase 2 meeting package to the FDA to discuss clinical requirements to advance DMT310 into Phase 3 development as a treatment for moderate-to-severe acne. The Company expects to receive written feedback on the end of phase 2 meeting package from the FDA by the end of June 2023. Upon agreement with the FDA, the Company plans to initiate the Phase 3 program for acne in the second half of 2023. If the Company is able to successfully complete the Phase 3 program, it believes the results could support submission of a new drug application for DMT310 for the treatment of moderate-to-severe acne.

https://finance.yahoo.com/news/dermata-announces-receipt-type-c-100000817.html