(Total Views: 523)
Posted On: 09/29/2022 7:40:06 PM
Post# of 157574
“purely to assess the probability that IIIF the BLA submission had been COMPLETED, it would pass an FDA-type GCP audit.”
Yes and let’s give the man some credit this is the most clarification we’ve had in awhile regarding the BLA.
Basically if it’s submitted it will be approved. Let’s just hope the damage isn’t so bad it wont pass.
Yes and let’s give the man some credit this is the most clarification we’ve had in awhile regarding the BLA.
Basically if it’s submitted it will be approved. Let’s just hope the damage isn’t so bad it wont pass.
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Daniel Rizzo
Federal Whistleblower
Case References
• HHS & SEC Whistleblower: HL-1412396
• DOJ Investigation Report / Whistleblower ID: 20250705-0001
• NIH Case Reference: CS1137565
• DoD Case: 16282
• IC IG / 50 U.S.C. §3033 / ARPA-H (Advanced Research Projects Agency for Health)
Founder & CEO
FireGate BioTech | AI Lux Veritas™
Contact FireGate Biotech
https://img1.wsimg.com/blobby/go/05a949a0-169...5_FULL.pdf
Federal Whistleblower
Case References
• HHS & SEC Whistleblower: HL-1412396
• DOJ Investigation Report / Whistleblower ID: 20250705-0001
• NIH Case Reference: CS1137565
• DoD Case: 16282
• IC IG / 50 U.S.C. §3033 / ARPA-H (Advanced Research Projects Agency for Health)
Founder & CEO
FireGate BioTech | AI Lux Veritas™
Contact FireGate Biotech
https://img1.wsimg.com/blobby/go/05a949a0-169...5_FULL.pdf
