(Total Views: 630)
Posted On: 08/29/2020 1:36:50 PM
Post# of 156982
Isn’t there anything we can do as the public/investors? Like start a lawsuit with the FDA ? I know it would be time and money but let’s just say it becomes more obvious that the FDA is playing games and we get delayed even more. Couldn’t we start some sort of investigation into them or maybe contact the DOJ to open a case?
I have contacts in the FBI and someone who works in the DOJ, I just don’t know if it’s something they can look into. Problem is law enforcement is a mess right now or has been.
No offense to any feds but the feds are lazy and useless so I can’t imagine them actually doing their job. Just saying you should see the city I work in. Last thing they want us to do, is the job. I know crazy to think... Anyways.
I agree that these are new times and I hope people start looking into the FDA I’m just not hopeful, yet....
Incompetent, lazy and corrupt that’s my thought. I work for the government and I can say it’s a mess and a joke sometimes.
I have contacts in the FBI and someone who works in the DOJ, I just don’t know if it’s something they can look into. Problem is law enforcement is a mess right now or has been.
No offense to any feds but the feds are lazy and useless so I can’t imagine them actually doing their job. Just saying you should see the city I work in. Last thing they want us to do, is the job. I know crazy to think... Anyways.
I agree that these are new times and I hope people start looking into the FDA I’m just not hopeful, yet....
Incompetent, lazy and corrupt that’s my thought. I work for the government and I can say it’s a mess and a joke sometimes.
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(0)
Daniel Rizzo
Federal Whistleblower
Case Numbers:
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 of FireGate Bioscience
USPTO: Inventor of the HIV Cure Protocol
[/img]https://investorshangout.com/images/MYImages/1472647104_IMG_3103.png[/img]
https://investorshangout.com/images/MYImages/...G_2859.png
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com
https://investorshangout.com/images/MYImages/..._3106.jpeg
https://investorshangout.com/images/MYImages/..._3107.jpeg
The underlying data is protected under federal law specifically 42 U.S.C. § 289b and its implementing regulation, 42 C.F.R. Part 93 through the Office of Research Integrity (askORI) within HHS, and coordinated with the Office of the Secretary / Office of Public Health and Science (OS/OPHS).
- Waiting…
whistleblower_complaints@wyden.senate.gov belongs to Senator Ron Wyden, a senior Democratic U.S. Senator from Oregon.
We are watching YOU……
“This isn’t conspiracy, this is criminal suppression.” - Ohm
https://www.justice.gov/usao-sdny/pr/us-attor...r-programs
https://investorshangout.com/images/MYImages/..._3015.jpeg
???? What Leronlimab Does
• Target: CCR5 receptor (the same receptor people with the CCR5Δ32 mutation lack — like the “Berlin” and “London” patients who were cured after stem cell transplants).
• Effect: By binding CCR5, leronlimab blocks HIV entry into CD4 cells.
• Trial Data:
• In combination therapy trials, ~81% of patients achieved viral loads <50 copies/mL (suppression, not cure).
• As monotherapy, some patients maintained suppression for long stretches (months), but not universally.
⸻
???? Why It Might Be Seen as a “Cure”
• In theory, if you completely block CCR5 on all relevant cells, HIV can’t infect new cells.
• If existing infected reservoirs naturally decay without replenishment, the virus could eventually vanish.
• That’s exactly what happened in the Berlin/London patients — except through stem cell transplants with CCR5Δ32 donors, not a drug.
⸻
???? Why It Hasn’t Been Called a Cure (Yet)
1. HIV Reservoirs Persist
Leronlimab blocks new infection, but it doesn’t flush latent virus from cells. Once treatment stops, those reservoirs can reignite infection.
2. CCR5-Independent Pathways
Some HIV strains use CXCR4 or dual-tropism (CCR5 + CXCR4). Leronlimab won’t stop those.
3. Clinical Conservatism
Researchers avoid using the word “cure” unless patients remain off all therapy with no viral rebound for years. Leronlimab hasn’t shown that in trials.
⸻
???? So Could It Alone Cure HIV?
• In select cases (if someone’s virus is purely CCR5-tropic and their reservoirs naturally decay): maybe.
• But in the general population, it’s unlikely as a monotherapy cure. More realistic is using it as part of a cure combo approach…
Covid
That dosing/timeline mismatch wasn’t just a “mistake.” It sabotaged the trial.
• Day 0 & Day 7 dosing + 10-day half-life = patients had strong coverage through Day 14.
• But the FDA chose Day 28 as the evaluation point……. after drug levels had waned.
• That’s not science. That’s setting the bar where the drug was least likely to shine.
Whether by incompetence or intent, the design ensured leronlimab looked weaker than it actually was. That’s sabotage …..and the community knows it.
In 2020–2021, during CytoDyn’s CD12 trial of leronlimab (PRO-140) in severe/critical COVID-19 patients, the company requested FDA approval to amend the trial design. They wanted to allow a higher 3/4 dosage regimen (because internal data suggested more frequent dosing might improve receptor occupancy and outcomes).
• NP (Nader Pourhassan, then CEO) and Jay Lalezari (Chief Medical Officer) both pushed for that adjustment.
• The FDA denied the request, keeping the protocol locked to the original dosing schedule.
• CytoDyn argued this limited the drug’s chance to demonstrate full efficacy in later-stage COVID patients.
• After the denial, NP frequently mentioned in calls and press releases that the FDA had “handcuffed” the trial design by not allowing higher or adjusted dosing.
So yes….the pushback happened, but the FDA didn’t authorize the dose modification. That denial became one of the sticking points investors and whistleblowers have flagged ever since.
Federal Whistleblower
Case Numbers:
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 of FireGate Bioscience
USPTO: Inventor of the HIV Cure Protocol
[/img]https://investorshangout.com/images/MYImages/1472647104_IMG_3103.png[/img]
https://investorshangout.com/images/MYImages/...G_2859.png
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com
https://investorshangout.com/images/MYImages/..._3106.jpeg
https://investorshangout.com/images/MYImages/..._3107.jpeg
The underlying data is protected under federal law specifically 42 U.S.C. § 289b and its implementing regulation, 42 C.F.R. Part 93 through the Office of Research Integrity (askORI) within HHS, and coordinated with the Office of the Secretary / Office of Public Health and Science (OS/OPHS).
- Waiting… whistleblower_complaints@wyden.senate.gov belongs to Senator Ron Wyden, a senior Democratic U.S. Senator from Oregon.
We are watching YOU……
“This isn’t conspiracy, this is criminal suppression.” - Ohm
https://www.justice.gov/usao-sdny/pr/us-attor...r-programs
https://investorshangout.com/images/MYImages/..._3015.jpeg
???? What Leronlimab Does
• Target: CCR5 receptor (the same receptor people with the CCR5Δ32 mutation lack — like the “Berlin” and “London” patients who were cured after stem cell transplants).
• Effect: By binding CCR5, leronlimab blocks HIV entry into CD4 cells.
• Trial Data:
• In combination therapy trials, ~81% of patients achieved viral loads <50 copies/mL (suppression, not cure).
• As monotherapy, some patients maintained suppression for long stretches (months), but not universally.
⸻
???? Why It Might Be Seen as a “Cure”
• In theory, if you completely block CCR5 on all relevant cells, HIV can’t infect new cells.
• If existing infected reservoirs naturally decay without replenishment, the virus could eventually vanish.
• That’s exactly what happened in the Berlin/London patients — except through stem cell transplants with CCR5Δ32 donors, not a drug.
⸻
???? Why It Hasn’t Been Called a Cure (Yet)
1. HIV Reservoirs Persist
Leronlimab blocks new infection, but it doesn’t flush latent virus from cells. Once treatment stops, those reservoirs can reignite infection.
2. CCR5-Independent Pathways
Some HIV strains use CXCR4 or dual-tropism (CCR5 + CXCR4). Leronlimab won’t stop those.
3. Clinical Conservatism
Researchers avoid using the word “cure” unless patients remain off all therapy with no viral rebound for years. Leronlimab hasn’t shown that in trials.
⸻
???? So Could It Alone Cure HIV?
• In select cases (if someone’s virus is purely CCR5-tropic and their reservoirs naturally decay): maybe.
• But in the general population, it’s unlikely as a monotherapy cure. More realistic is using it as part of a cure combo approach…
Covid
That dosing/timeline mismatch wasn’t just a “mistake.” It sabotaged the trial.
• Day 0 & Day 7 dosing + 10-day half-life = patients had strong coverage through Day 14.
• But the FDA chose Day 28 as the evaluation point……. after drug levels had waned.
• That’s not science. That’s setting the bar where the drug was least likely to shine.
Whether by incompetence or intent, the design ensured leronlimab looked weaker than it actually was. That’s sabotage …..and the community knows it.
In 2020–2021, during CytoDyn’s CD12 trial of leronlimab (PRO-140) in severe/critical COVID-19 patients, the company requested FDA approval to amend the trial design. They wanted to allow a higher 3/4 dosage regimen (because internal data suggested more frequent dosing might improve receptor occupancy and outcomes).
• NP (Nader Pourhassan, then CEO) and Jay Lalezari (Chief Medical Officer) both pushed for that adjustment.
• The FDA denied the request, keeping the protocol locked to the original dosing schedule.
• CytoDyn argued this limited the drug’s chance to demonstrate full efficacy in later-stage COVID patients.
• After the denial, NP frequently mentioned in calls and press releases that the FDA had “handcuffed” the trial design by not allowing higher or adjusted dosing.
So yes….the pushback happened, but the FDA didn’t authorize the dose modification. That denial became one of the sticking points investors and whistleblowers have flagged ever since.
