The tricky thing about FDA paraphrasing

Yesterday, the CEO of Ovid Therapeutics told the world that the FDA “agreed” with his company’s plans for a rare disease drug trial, clearing the way for a study that would support approval if it’s positive.

That’s good news for Ovid, which has struggled to engender investor confidence in its lead drug, a treatment for the rare and debilitating Angelman syndrome. But it also underlines a biotech truism: When the subject is interactions with the FDA, it’s always a one-sided conversation.

The FDA is prohibited from disclosing anything from closed-door meetings with companies developing drugs. That means any news about those meetings comes only from the companies themselves, and their characterizations don’t always jibe with the FDA’s eventual decisions.

There’s no reason to think the FDA hasn’t “agreed” with Ovid, as its CEO, Jeremy Levin said, but investors can be forgiven for calling to mind the cases of Trevena and Sarepta Therapeutics.