A High-Stakes Regulatory Confrontation

Biotech firm Replimune confronts a pivotal moment for its future as it engages in a decisive Type-A meeting with U.S. regulators today. The company’s chief executive, Sushil Patel, has issued a stark warning that the entire RP1 program for melanoma treatment will become unsustainable without securing an accelerated approval pathway.

The crucial dialogue with the Food and Drug Administration commenced at 7:20 AM Eastern Time this morning. Replimune has presented comprehensive Read more...