Regarding the upcoming call next week “ to discu
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Posted On: 12/23/2022 11:56:02 AM
Regarding the upcoming call next week “ to discuss the performance of leronlimab in its clinical trials and the recent charges against its former CEO”, I will not be surprised if they put some perspective on the performance of the drug connected to the “charges.”
I am not defending Pourhassan here, charges and allegations will be aired out in the court so I will not make any presumption of guilt or innocence, however….these two allegations in the DOJ filing I think it fair to say undercut the real performance of the drug:
“ The indictment also alleges that Pourhassan made, and caused CytoDyn to make, materially false and misleading representations about CytoDyn’s investigation and development of leronlimab as a potential treatment for COVID-19, including the results and significance of clinical trials and the status of CytoDyn’s regulatory submissions to the FDA. Pourhassan allegedly knew that, in truth and in fact, leronlimab’s clinical studies failed to achieve the results necessary to obtain any form of FDA approval for use as a treatment for COVID-19 and the results CytoDyn publicly touted were neither statistically significant nor scientifically sound.”
And: “In this case, these individuals took advantage of the dream of a possible new treatment for HIV and exploited investors, while dashing the hopes of many waiting for a cure.”
The facts are that the HIV trial with statistically significant results does show a possible new treatment for HIV; unfortunately Amarex performance as our CRO precludes a bonifide BLA filing and that has only recently been confirmed by independent consultants. Further, while the covid19 studies did not reach clinical significance the evidence in Toto (Montefiore patients, Lalezari’s patient in the UK that came off an 89 day stint on ECMO within a few days of Leronlimab treatment, Recknor’s personal experience, and it should be said the severe/critical study itself) scream that Leronlimab works better than anything out there for covid19. “Nor scientifically sound” I also object to: the mechanism of action of Leronlimab as it relates to “calming the cytokine storm” is well understood here and plays directly into death from covid19 following on the heels of a fulminant inflammatory response…it’s why steroids have made an impact. I have always considered Fauci’s statement regarding Remdesivir “trending toward significance” the height of hypocrisy when compared to a studied evaluation of Leronlimab and no EUA with millions dying that may well have been saved.
Whatever Nader’s failings, while he has a propensity to put the most positive spin on things, I believe the enthusiasm expressed for the drug was righteously justified and defensible.
I am not defending Pourhassan here, charges and allegations will be aired out in the court so I will not make any presumption of guilt or innocence, however….these two allegations in the DOJ filing I think it fair to say undercut the real performance of the drug:
“ The indictment also alleges that Pourhassan made, and caused CytoDyn to make, materially false and misleading representations about CytoDyn’s investigation and development of leronlimab as a potential treatment for COVID-19, including the results and significance of clinical trials and the status of CytoDyn’s regulatory submissions to the FDA. Pourhassan allegedly knew that, in truth and in fact, leronlimab’s clinical studies failed to achieve the results necessary to obtain any form of FDA approval for use as a treatment for COVID-19 and the results CytoDyn publicly touted were neither statistically significant nor scientifically sound.”
And: “In this case, these individuals took advantage of the dream of a possible new treatment for HIV and exploited investors, while dashing the hopes of many waiting for a cure.”
The facts are that the HIV trial with statistically significant results does show a possible new treatment for HIV; unfortunately Amarex performance as our CRO precludes a bonifide BLA filing and that has only recently been confirmed by independent consultants. Further, while the covid19 studies did not reach clinical significance the evidence in Toto (Montefiore patients, Lalezari’s patient in the UK that came off an 89 day stint on ECMO within a few days of Leronlimab treatment, Recknor’s personal experience, and it should be said the severe/critical study itself) scream that Leronlimab works better than anything out there for covid19. “Nor scientifically sound” I also object to: the mechanism of action of Leronlimab as it relates to “calming the cytokine storm” is well understood here and plays directly into death from covid19 following on the heels of a fulminant inflammatory response…it’s why steroids have made an impact. I have always considered Fauci’s statement regarding Remdesivir “trending toward significance” the height of hypocrisy when compared to a studied evaluation of Leronlimab and no EUA with millions dying that may well have been saved.
Whatever Nader’s failings, while he has a propensity to put the most positive spin on things, I believe the enthusiasm expressed for the drug was righteously justified and defensible.
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