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 studyAccording 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 trialMydecine plans to submit a…