After already receiving two complete response letters, the company resubmitted the BLA in May. Replimune executives were making their case throughout the morning July 30, while the FDA and adcom members acknowledged the challenges of demonstrating response with a single-arm trial involving patients with an unmet need. Sail will bank $785 million from J&J, including a $465 million equity investment and milestone payments of $140 million if certain development goals are achieved. US CDC, ASPR nominees get HELPing hand toward Senate confirmationErica Schwartz is one step away from becoming the next director of the U.S. CDC. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-10 today to favorably report her nomination to the Senate floor for confirmation.