Mind Medicine (NEO: MMED) this morning indicated that things are not going quite to plan with an IND submission for a Phase 2b trial focused on examining the use of LSD for the treatment of generalized anxiety disorder. The FDA evidently has placed a clinical hold on the study.
The justification for the clinical hold has not yet been revealed, with the company commenting that it expects additional details from the decision within the next thirty days. A clinical hold, as described by the FDA, is “an order issued by FDA to the sponsor of an IND application to delay a proposed clinical investigation or to suspend an ongoing investigation.”
A number of justifications exist for why a clinical hold may take place, but the short of it is that the regulator is not happy with one aspect of the proposed study. While the first phase outlines five potential reasons for why a study may be placed on hold, including unreasonable risk for human subjects, unqualified investigators, insufficient information, risk of reproductive or developmental toxicity and an erroneous brochure, the second phase sees the addition of potential hold due to deficient study design to meet stated objectives. It is currently unclear what grounds the study was placed on hold for.
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Further information was not provided by the company on the matter.
Mind Medicine last traded at $2.12 on the Neo.
Information for this briefing was found via Sedar and MindMed. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
