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Posted On: 03/08/2021 8:52:14 AM
Post# of 148908
Letter from Dr. Bream To Dr. Woodcock:
Janet.woodcock@fda.hhs.gov
Dr. Woodcock,
CytoDyn released its top-line results for severe/critical COVID-19 this weekend, and it was nothing short of phenomenal. As you’re likely well-aware, the trial achieved statistical significance by decreasing hospitalization by 6 days in intubated patients. When adjusted for age, leronlimab was the first drug ever to achieve a statistically significant mortality benefit (p=.03) in a randomized, placebo controlled trial.
You have the power, and I would argue the ethical obligation, to grant an EUA based on this data. That decision is yours - and yours alone. Almost 540,000 Americans have died in this pandemic. How many of them could leronlimab have saved? How many of the more than 40,000 hospitalized today could benefit from leronlimab? The data unequivocally suggests leronlimab could save a lot of lives.
Moreover, the decision to grant an EUA based on age-adjusted and subgroup data isn’t unfounded. In the RECOVERY trial, the data for Decadron was age-adjusted and parsed into subgroups (intubated, oxygen, no oxygen) for its landmark data which is now the standard of care. Also, note that the RECOVERY trial was open-label.
CytoDyn’s trial of leronlimab was double-blinded, placebo (SoC) controlled and showed statistically significant benefits in mortality for critically ill patients and mortality benefit across the entire trial population in combination with Decadron (when age-adjusted), and length of stay in intubated patients was statistically significant even without the adjustment. Through no fault of its own, the age imbalance between trial arms (DSMC should have caught this) is literally now a life or death unfortunate event.
You have openly said that you don’t think people should die for a p-value. However, that’s exactly what you’re allowing right now by not issuing an EUA for leronlimab. I implore you to re-evaluate that decision and appeal to your humanity. Would you want your family member to get leronlimab if intubated or the current standard of care? I would want leronlimab.
As an emergency physician, I’ve admitted hundreds of patients - many of them to die - without any hope that they would live. Leronlimab gives those patients hope. It gives families hope. It gives me hope. But, for that hope to become reality, it is desperately needed for an EUA to be issued.
I beg you to issue the EUA. I don’t want any more of my patients to die without the hope leronlimab will provide to them and their families.
Respectfully,
John Bream, MD, FACEP
Janet.woodcock@fda.hhs.gov
Dr. Woodcock,
CytoDyn released its top-line results for severe/critical COVID-19 this weekend, and it was nothing short of phenomenal. As you’re likely well-aware, the trial achieved statistical significance by decreasing hospitalization by 6 days in intubated patients. When adjusted for age, leronlimab was the first drug ever to achieve a statistically significant mortality benefit (p=.03) in a randomized, placebo controlled trial.
You have the power, and I would argue the ethical obligation, to grant an EUA based on this data. That decision is yours - and yours alone. Almost 540,000 Americans have died in this pandemic. How many of them could leronlimab have saved? How many of the more than 40,000 hospitalized today could benefit from leronlimab? The data unequivocally suggests leronlimab could save a lot of lives.
Moreover, the decision to grant an EUA based on age-adjusted and subgroup data isn’t unfounded. In the RECOVERY trial, the data for Decadron was age-adjusted and parsed into subgroups (intubated, oxygen, no oxygen) for its landmark data which is now the standard of care. Also, note that the RECOVERY trial was open-label.
CytoDyn’s trial of leronlimab was double-blinded, placebo (SoC) controlled and showed statistically significant benefits in mortality for critically ill patients and mortality benefit across the entire trial population in combination with Decadron (when age-adjusted), and length of stay in intubated patients was statistically significant even without the adjustment. Through no fault of its own, the age imbalance between trial arms (DSMC should have caught this) is literally now a life or death unfortunate event.
You have openly said that you don’t think people should die for a p-value. However, that’s exactly what you’re allowing right now by not issuing an EUA for leronlimab. I implore you to re-evaluate that decision and appeal to your humanity. Would you want your family member to get leronlimab if intubated or the current standard of care? I would want leronlimab.
As an emergency physician, I’ve admitted hundreds of patients - many of them to die - without any hope that they would live. Leronlimab gives those patients hope. It gives families hope. It gives me hope. But, for that hope to become reality, it is desperately needed for an EUA to be issued.
I beg you to issue the EUA. I don’t want any more of my patients to die without the hope leronlimab will provide to them and their families.
Respectfully,
John Bream, MD, FACEP
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