MYCO:CC - Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) Reports Positive Pre-IND Meeting with FDA Changes to Its Clinical Trial Approach; Plans Breakthrough Therapy Designation Request for MYCO-001
- Mydecine recently reported a positive Pre-IND meeting with the FDA for the MYCO-001 smoking cessation study
- According to the Center for Disease Control (“CDC”), tobacco is the leading cause of preventable deaths in the U.S.
- Following the FDA meeting, the company now intends to perform a Phase 2b study and then a Phase 3 study instead of a seamless Phase 2/3 clinical trial
- Mydecine plans to submit a request for breakthrough therapy status with its IND submission
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) has continually taken steps toward fulfilling its mission to become a trusted source of safe and effective medication-based treatments for mental health and addiction disorders by developing drug candidates, partnering to advance research, and more.
Under the stewardship of Dr. Matthew W. Johnson, Ph.D., a Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins University (“JHU”) contracted last September (https://ibn.fm/SnsIY), for example, Mydecine plans to conduct a placebo-controlled study evaluating the...
NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at http://ibn.fm/MYCOF
About PsychedelicNewsWire
PsychedelicNewsWire (PNW) is a specialized content distribution company that (1) aggregates and distributes news and information on the latest developments in all aspects and advances of psychedelics and their use, (2) creates PsychedelicNewsBreaks designed to quickly update investors on important industry news, (3) leverages a team of expert editors to enhance press releases for maximum impact, (4) assists companies with the management and optimization of social media across a range of platforms, and (5) delivers unparalleled corporate communication solutions. PNW stays abreast of the latest information and has established a reputation as the go to source for coverage of psychedelics, therapeutics and emerging market opportunities. Our team of seasoned journalists has a proven track record of helping both public and private companies gain traction with a wide audience of investors, consumers, media outlets and the general public by leveraging our expansive dissemination network of more than 5,000 key syndication outlets. PNW is committed to delivering improved visibility and brand recognition to companies operating in the emerging markets of psychedelics.
To receive instant SMS alerts, text “Groovy” to 21000 (U.S. Mobile Phones Only)
For more information please visit https://www.PsychedelicNewsWire.com
Please see full terms of use and disclaimers on the PsychedelicNewsWire website applicable to all content provided by PNW, wherever published or re-published: https://www.PsychedelicNewsWire.com/Disclaimer
Do you have questions or are you interested in working with PNW? Ask our Editor
PsychedelicNewsWire (PNW)
San Francisco, California
www.PsychedelicNewsWire.com
415.949.5050 Office
Editor@PsychedelicWire.com
PsychedelicNewsWire is part of the InvestorBrandNetwork.