With Replimune decision, FDA again appears to reverse course from prior advice

Shifting FDA standards may be making the path to market less predictable for biotechs. One more company professed surprise Tuesday at receiving a complete response letter after an otherwise uneventful product review, joining others that have had their programs upended.

By apparently moving the goalposts, FDA has raised questions about whether agreements companies made with the agency under its previous leadership remain valid. And in the absence of public statements about changes in standards, companies face increasing uncertainty about the approval decisions in coming months...