Amarex data was a major issue in 2022, you are co
Post# of 155652
(Total Views: 555)
Posted On: 02/26/2025 9:14:49 PM
Amarex data was a major issue in 2022, you are correct. They could have gotten more insight into Amarex after the lawsuit.
I don’t want to confuse you or even more.
Simply OHM is right. As far as I’m aware the BLA is definitely dead. Until the company says otherwise which they probably won’t. It’s dead.
Playing devils advocate. Anything is possible but we have no proof they plan on filing it again.
I will say an approval goes beyond MDR pop the value is so much more than just this. It’s beyond that. I mean Samsung doesn’t get paid without an approval. The list can go on. How long do they plan on waiting.
I think all of this, is to address the FDAs concerns for upcoming trials and not the BLA until told otherwise.
I don’t want to confuse you or even more.
Simply OHM is right. As far as I’m aware the BLA is definitely dead. Until the company says otherwise which they probably won’t. It’s dead.
Playing devils advocate. Anything is possible but we have no proof they plan on filing it again.
I will say an approval goes beyond MDR pop the value is so much more than just this. It’s beyond that. I mean Samsung doesn’t get paid without an approval. The list can go on. How long do they plan on waiting.
I think all of this, is to address the FDAs concerns for upcoming trials and not the BLA until told otherwise.
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Daniel Rizzo
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com