Mind Medicine (“MindMed”) (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), a leading biotech company developing psychedelic-inspired therapies, recently met with the United States Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) with consultation from the Center for Drug Evaluation and Research (“CDER”). The device pre-submission meeting that took place on Oct. 25, 2021, was concerning several key points for ongoing development of the MindMed Session Monitoring System (“MSMS”). MindMed presented the FDA with a working Indications for Use (“IFU”) statement and a development roadmap, which describe technology and infrastructure for the collection of precise, multimodal, multivalent data that can be processed via machine learning, artificial intelligence, signal processes and other statistical methods. Key feedback regarding the draft IFU and research methods was provided by the FDA, which 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,” said Daniel R Karlin, MD MA, chief medical officer of MindMed. “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.”
To view the full press release, visit https://ibn.fm/IbnhX
About MindMed
MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies. MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ. For more information about the company, visit www.MindMed.co.
About BioMedWire
BioMedWire (BMW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) BioMedNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. BMW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled visibility, recognition and brand awareness. BMW is where news, content and information converge.
To receive SMS text alerts from BioMedWire, text “STOCKS” to 77948 (U.S. Mobile Phones Only)
For more information please visit https://www.BioMedWire.com
Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: http://BMW.fm/Disclaimer
BioMedWire (BMW)
San Francisco, California
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com
BioMedWire is part of the InvestorBrandNetwork