Psychedelic biotechnology company developing and commercializing psychedelic-inspired medicine and therapies to treat addiction and mental illnesses MindMed Inc. (NASDAQ: MNMD) (NEO: MMED) held a meeting with the U.S Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) with consultation from Center for Drug Evaluation and Research (CDER) concerning major points linked to the ongoing development of MindMed Session Monitoring System (MSMS).
The above consultation took place during a pre-submission meeting which happened back in October 25 in which the company presented FDA with working indications for use statement (IFU) and a development roadmap.
The presentation captured the technology and infrastructure for the collection of precise, multimodal, multivalent data which can be processed through machine learning, artificial intelligence, signal processes and other statistical methods to give clinically meaningful output which satisfies the requirement of IFU.
The company’s chief medical officer, Daniel R Karlin, confirmed that FDA gave them much needed feedback regarding the draft IFU and the research methodology that will lay the foundation for regulatory submissions.
“We regard our regulators as key stakeholders throughout the device development process and seek meetings with FDA as early and often as feasible. These regulatory engagements provide the opportunity to thoroughly and continually discuss and assess alignment around the various considerations, which are essential to the success and adoption of MindMed’s Session Monitoring System’s regulated components. The FDA is supportive of our plans to develop regulated devices that would allow the use of novel analyses of multimodal data to capture, model, and map outputs that, if cleared, could be useful to clinicians and patients in the delivery of psychedelic and other perception-altering substances,” said Karlin.