Bubalan Pachayapan's questions to Capricor Therapeutics Inc (CAPR) leadership • Q2 2025
Question
An analyst dialing in for Bubalan Pachayapan asked if the Type A meeting is an opportunity for FDA clarification or a bellwether for a future resubmission, and also questioned the value of the mid-cycle review process given the CRL outcome.
Answer
CEO Linda Marbán stated that Capricor will share information from the meeting as it becomes available. Regarding the review process, she commented that in their experience, a successful mid-cycle review was not predictive of the final BLA outcome. She also noted that the company's current focus is on U.S. approval before advancing ex-U.S. strategies.