This should go to every media outlet! Leronlima
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Posted On: 05/25/2025 8:02:37 AM
This should go to every media outlet!
Leronlimab—Suppressed Potential or Missed Opportunity?
CytoDyn’s drug leronlimab met its primary endpoint in a pivotal Phase 3 HIV trial. During COVID-19, top physicians including Dr. Seethamraju (Montefiore) and Dr. Otto Yang (UCLA) obtained Emergency Use Authorizations from the FDA to treat critically ill patients. The outcomes were dramatic—some intubated and ECMO patients fully recovered, with results published in prestigious journals like The New England Journal of Medicine.
Despite a 33% mortality reduction in critical patients, the FDA confined its trial design to moderately ill individuals, where the primary endpoint was not met. Physicians repeatedly affirmed leronlimab’s safety and efficacy, yet no authorization was granted.
Instead, the DOJ prosecuted CytoDyn’s CEO and CRO CEO. Both were acquitted of the central conspiracy charge, but convicted on lesser counts—despite rejecting plea deals that would’ve dropped most charges.
Subpoenaed FDA internal communications revealed:
A top FDA official saying, “I’m not going to look at their data. I’ll just deny it.”
The Director of Antiviral Products asking: “Why is this drug working?”
The FDA’s BLA review chief confirming CytoDyn’s application was reviewable—contrary to DOJ claims.
The leronlimab story represents a regulatory paradox: clinical promise overshadowed by political pressure and bureaucratic bias. With new leadership or partnerships, this drug’s future could still be lucrative—for patients and shareholders.
Leronlimab—Suppressed Potential or Missed Opportunity?
CytoDyn’s drug leronlimab met its primary endpoint in a pivotal Phase 3 HIV trial. During COVID-19, top physicians including Dr. Seethamraju (Montefiore) and Dr. Otto Yang (UCLA) obtained Emergency Use Authorizations from the FDA to treat critically ill patients. The outcomes were dramatic—some intubated and ECMO patients fully recovered, with results published in prestigious journals like The New England Journal of Medicine.
Despite a 33% mortality reduction in critical patients, the FDA confined its trial design to moderately ill individuals, where the primary endpoint was not met. Physicians repeatedly affirmed leronlimab’s safety and efficacy, yet no authorization was granted.
Instead, the DOJ prosecuted CytoDyn’s CEO and CRO CEO. Both were acquitted of the central conspiracy charge, but convicted on lesser counts—despite rejecting plea deals that would’ve dropped most charges.
Subpoenaed FDA internal communications revealed:
A top FDA official saying, “I’m not going to look at their data. I’ll just deny it.”
The Director of Antiviral Products asking: “Why is this drug working?”
The FDA’s BLA review chief confirming CytoDyn’s application was reviewable—contrary to DOJ claims.
The leronlimab story represents a regulatory paradox: clinical promise overshadowed by political pressure and bureaucratic bias. With new leadership or partnerships, this drug’s future could still be lucrative—for patients and shareholders.
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