CINCINNATI, OH (FSCwire) - M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2), (the “Company” or “M Pharma”), a clinical-stage company developing innovative technologies for weight management and female health and wellness announced today that it has taken important steps to draft and file a Pre Investigational New Drug (PIND) Meeting Request and Package to the US FDA for our Extrinsa™ topical drug product. With significant assistance from Camargo Pharmaceutical Services, submission should be made in the next 7 business days to the FDA, with a written response or face-to-face meeting expected in 60 days or less.
“The PIND Meeting Request Letter and Package Submission and subsequent Meeting Response Letter from the FDA for the C-103 development project gave us a very clear path to the requirements that must be met for approval of the C-103 drug product; we are hoping for the same level of response and clarity from the FDA for Extrinsa™,” said James Thompson, Chief Operating Officer of M Pharmaceutical USA Inc. “Once we have a face-to-face meeting with the FDA staff or receive and incorporate their recommended adjustments from a written response letter, we should have clearly defined requirements for a path to drug approval and market in the US.”
Camargo Pharmaceutical Services has been engaged to advance our Extrinsa™ drug product through the FDA approval process via the 505(b) (2) pathway, similar to our C-103 project. They have already delivered a thorough GAP Analysis Report, outlining the tentative approval pathway, clinical and development requirements as well as initial cost estimates involved for the drug development program through NDA submission with US FDA.