The unusual criticism of the FDA regulator to therapy is stirring Wall Street

Adam Feuerstein is a main writer and biotechnology columnist, reporting on the crossroads of drug development, business, Wall Street and biotechnology. He is also co-host of the weekly biotech podcast The Readout Loud and author of the Biotech dashboard of the Adam newsletter. You can reach Adam on the signal to stataf.54.

George Tidmarsh, the best regulator of the Food and Drug Administration, try to take revenge on an eminent Wall Street investor after a meeting with him six years ago?

This is the question that biotechnological investors stirred on all on Monday after Tidmarsh used his LinkedIn personal page to raise questions on voclosporin safety, a rather obscure drug that the FDA approved in 2021 to treat patients with nephrite lupus, a type of autoimmune disease that damages the kidneys.

Voclosporin has a “significant toxicity,” wrote Tidmarsh in his LinkedIn article, adding that the drug “has not been shown to bring a direct clinical advantage to patients”.