Shares of Capricor Therapeutics (CAPR) tanked more than 67% on Monday after U.S. Food and Drug Administration (FDA) reviewers expressed concerns in briefing documents over whether its lead therapy Deramiocel has shown sufficient effectiveness to treat cardiomyopathy in patients with Duchenne muscular dystrophy (DMD).

However, the company responded by stating that the FDA’s review was based on an unsigned, incomplete, and obsolete internal draft.

“Our results are governed by the final analysis plan, SAP version 3.0, which was finalized prior to unblinding. It is critical to understand that the post-hoc analyses in the FDA’s briefing materials rely on SAP version 1.1, an unsigned, incomplete internal draft which became obsolete with…