Friday, December 10, 2021

QualityStocksNewsBreaks – Mind Medicine (‘MindMed’) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ) Engages with FDA for Development of the ‘MSMS’

 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/zlvmv

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 QualityStocksNewsBreaks

QualityStocksNewsBreaks provide a rapid summary of corporate news that catch the attention of QualityStocks. QualityStocksBreaks are designed to keep investors up to date on important and breaking news in the small-cap and micro-cap markets. Spanning all industries, including energy, entertainment, telecommunications, healthcare, retail and more, these news breaks deliver opportunities the investment community may have missed. Whether it is earnings results, mergers and acquisitions, or any other market-moving news, our news breaks keep you in the know. QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. It is part of our mission statement to help the investment community discover emerging companies that offer excellent growth potential.

QualityStocks (QS)
Scottsdale, Arizona
www.QualityStocks.com
480.374.1336 Office
Editor@QualityStocks.com

Please see full terms of use and disclaimers on the QualityStocks website applicable to all content provided by QS, wherever published or re-republished: http://www.qualitystocks.net/disclaimer.php

No comments: