FDA Headed For A Shakeup With Michael Davis Appointment?

In our latest Trade To Black podcast presented by Flowhub, hosts Shadd Dales and Anthony Varrell break down yet more encouraging news for the cannabis and psychedelic industries. In segment one, the guys discuss the appointment of Michael Davis to lead the FDA Center for Drug Evaluation and Research following major leadership shakeups inside the agency. Davis has deep experience in psychiatric drug development and psychedelic-based therapeutics at a time when Compass Pathways (NASDAQ: CMPS) is rapidly moving toward potential FDA approval for COMP360. We’ll dive into the latest earnings from Safe Harbor Financial (NASDAQ: SHFS), and in segment two, Michael Bronstein from the American Trade Association for Cannabis and Hemp joins the show as all eyes turn toward Virginia.

A significant development in the psychedelic medicine space: the elevation of Dr. Michael Davis to Acting Director of the FDA’s Center for Drug Evaluation and Research following a period of leadership turmoil inside the agency. Davis holds an extensive background in psychiatric drug review and previously served as Chief Medical Officer for a nonprofit focused on psychedelic-based therapies before returning to the FDA.

His appointment might be a meaningful signal for the industry, particularly for Compass Pathways, whose COMP360 psilocybin treatment for treatment-resistant depression is currently in rolling NDA submission with a priority review voucher that could significantly shorten the FDA’s review timeline.

Safe Harbor Financial’s latest earnings show continued discipline under CEO Terry Mendez, including modest revenue growth, sharply higher loan program income, reduced operating expenses, and a swing from negative to positive equity. Is Safe Harbor’s evolution into a full-spectrum financial services platform tailored to small and mid-sized cannabis operators paying off? We’ll discuss.

Michael Bronstein, president of the American Trade Association for Cannabis and Hemp, joins the show for the Insider’s Edge segment, offering a detailed look at the regulatory and political landscape ahead of the June ALJ hearing. Opposition groups like SAM are well-funded and should not be underestimated. On Virginia’s adult-use bill, Bronstein said intelligence was pointing in both directions with no clear outcome ahead of Governor Abigail Spanberger’s Friday deadline, with veto risk remaining very real following her rejection of several proposed amendments. He also provided a Pennsylvania update, noting that gaming interests have poured close to ten million dollars into state primary races, creating significant tension in the Senate caucus that continues to complicate cannabis legalization prospects there.

This and more when you tune in.


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