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Monday, March 29, 2021 12:40:46 AM
Dr. Bream is among a growing chorus of voices urging the FDA to speed approval of this life-saving drug. Phase 3 trials demonstrate impressive efficacy well beyond other drugs that were approved but are not nearly as effective. The safety record of Leronlimab is still flawless after six year of regular use on HIV patients.
An estimated 40% more patients on ventilators would survive through the use of CytoDyn's Leronlimab and hospital stays have been found to average six fewer days.
Each day that passes puts more people at risk by holding back on a timely approval, especially since safety is clearly not an issue. Six fewer days at $25,000 per day, saves tremendously on costs and healthcare resources - significantly impacting the availability of hospital beds.
FDA Director, Dr. Woodcock, should wave the three month trial being done only to very slightly increase the p-value. We are in a pandemic and many lives could be saved by acting now.
Dr. Woodcock herself is famous for asking the rhetorical questions, "Would you risk your own life to raise a p-value?" Please take your own oh-so-obvious advice and move forward with the approval a soon as is humanly possible.
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