Summary of Leronlimab’s Path and Regulatory Conf
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Posted On: 05/25/2025 8:05:47 AM
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Summary of Leronlimab’s Path and Regulatory Conflict
Under Dr. Nader Pourhassan’s leadership, CytoDyn’s drug leronlimab reached a major milestone by meeting its primary endpoint in a pivotal Phase 3 HIV trial. Amid the COVID-19 pandemic, several prominent physicians, including Dr. Seethamraju of Montefiore and Dr. Otto Yang of UCLA, independently sought Emergency Use Authorizations (EUAs) for critically ill COVID patients. Many of these patients experienced extraordinary recoveries—some from intubation or ECMO—prompting published findings in top-tier medical journals like the New England Journal of Medicine.
Despite real-world evidence and continuous safety affirmation from frontline physicians, the FDA limited CytoDyn’s COVID-19 trial to moderately ill patients—excluding the population where the drug had shown the most dramatic results. Still, in that critical group, leronlimab demonstrated a 33% mortality reduction.
While doctors and patients publicly attested to the drug’s life-saving potential, the DOJ pursued criminal charges against Dr. Pourhassan and Dr. Kazempour, CEOs of CytoDyn and its CRO. Both were acquitted of the central charge—conspiracy—but were convicted on lesser charges, despite rejecting plea deals that would have required them to admit to the very charge the jury dismissed.
During the trial, internal FDA emails—obtained via subpoena—unveiled a pattern of bias, hostility, and predetermined dismissal toward CytoDyn:
One official called CytoDyn “the mother f— company” and refused to even examine their data.
FDA Director Dr. Debra Birnkrant herself asked, “Why is this drug working?”—a striking question coming from a top regulator.
Internal communication contradicted the DOJ’s central claim that CytoDyn’s BLA was “unreviewable”; the FDA’s own BLA team lead stated otherwise.
Implications
This story raises urgent questions about regulatory integrity, institutional transparency, and the consequences of bureaucratic bias in the face of potential medical breakthroughs. It suggests a troubling disconnect between frontline medical evidence and the actions of those entrusted with public health oversight.
It also invites the public and policymakers to ask:
What if a life-saving drug was buried—not because it failed patients, but because it challenged a system unprepared for disruptive innovation?
Under Dr. Nader Pourhassan’s leadership, CytoDyn’s drug leronlimab reached a major milestone by meeting its primary endpoint in a pivotal Phase 3 HIV trial. Amid the COVID-19 pandemic, several prominent physicians, including Dr. Seethamraju of Montefiore and Dr. Otto Yang of UCLA, independently sought Emergency Use Authorizations (EUAs) for critically ill COVID patients. Many of these patients experienced extraordinary recoveries—some from intubation or ECMO—prompting published findings in top-tier medical journals like the New England Journal of Medicine.
Despite real-world evidence and continuous safety affirmation from frontline physicians, the FDA limited CytoDyn’s COVID-19 trial to moderately ill patients—excluding the population where the drug had shown the most dramatic results. Still, in that critical group, leronlimab demonstrated a 33% mortality reduction.
While doctors and patients publicly attested to the drug’s life-saving potential, the DOJ pursued criminal charges against Dr. Pourhassan and Dr. Kazempour, CEOs of CytoDyn and its CRO. Both were acquitted of the central charge—conspiracy—but were convicted on lesser charges, despite rejecting plea deals that would have required them to admit to the very charge the jury dismissed.
During the trial, internal FDA emails—obtained via subpoena—unveiled a pattern of bias, hostility, and predetermined dismissal toward CytoDyn:
One official called CytoDyn “the mother f— company” and refused to even examine their data.
FDA Director Dr. Debra Birnkrant herself asked, “Why is this drug working?”—a striking question coming from a top regulator.
Internal communication contradicted the DOJ’s central claim that CytoDyn’s BLA was “unreviewable”; the FDA’s own BLA team lead stated otherwise.
Implications
This story raises urgent questions about regulatory integrity, institutional transparency, and the consequences of bureaucratic bias in the face of potential medical breakthroughs. It suggests a troubling disconnect between frontline medical evidence and the actions of those entrusted with public health oversight.
It also invites the public and policymakers to ask:
What if a life-saving drug was buried—not because it failed patients, but because it challenged a system unprepared for disruptive innovation?
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