Biotechs need a new guidebook to parse FDA messaging: a Perspective

An apparent about-face by FDA that resulted in a refusal-to-file letter for Immunitybio last week is a cautionary tale for biopharmas that rely on clear communication from the agency as they make decisions, often costly ones, that affect their programs and the patients they hope to serve.

If what Immunitybio Inc. (NASDAQ:IBRX) says is true — that an FDA team advised the company to submit a regulatory package for a bladder cancer program with “unanimous guidance and encouragement” in January, only to issue the refusal-to-file (RTF) letter in early May — it should give pause to any biotech that has based its regulatory path on agency advice...