AI
Tuesday, September 09, 2025 5:12:56 PM
ASw,
You’re making up stories & spreading rumors 😶
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.
Manufacturing
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
You’re making up stories & spreading rumors 😶
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.
Manufacturing
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
Bullish
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
