They did not “pass” on the FDA, and the FDA has approved several DC clinical studies to commence subsequent to the P3. Additionally, the U.S. NIH & U.S. DoD have awarded and renewed peer-reviewed grants for combo research with the DC platforms at Roswell & UCLA.
Anyone can research this for themselves or contact the FDA to ask them…
Fact ✅️:
Demonstrating the ability to consistently manufacture a product at commercial scale is a core requirement for a BLA. The FDA requires sponsors to show they can reliably produce the therapy at the necessary scale with consistent quality & full compliance with Good Manufacturing Practices.
Ask the FDA: Division of Industry & Consumer Education (DICE) 1-888-INFO-FDA (1-888-463-6332) DICE@fda.hhs.gov Center for Biologics Evaluation & Research (CBER) Customer Service: 1-800-835-4709 CBERCustomerService@fda.hhs.gov
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