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Posted On: 10/30/2023 3:54:33 PM
Post# of 148878
Re: biloxiblues #138514
Wow, great info. So how did we go from Dec 21, 2021 full Covid 4 shot FDA acceptance to March 30, 2022 total hold on Covid and partial on HIV? This is what Cyrus had to deal with! Someone put the "hold' on us. Here Dec 21, 2021:
CytoDyn Receives Positive Response From FDA in Regard to its Phase 3, Registrational Trial in COVID-19 Critically Ill Population
Published: Dec 21, 2021
FDA also allows integrated or meta-analysis of the previous trial results in CD20 final analysis
CD20 is allowed to have four dosages of leronlimab in the first four weeks via IV infusion
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has received a positive response from the U.S. Food and Drug Administration (“FDA”) to conduct a Phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for Invasive Mechanical Ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).
The submission of this protocol was previously announced on December 9th. Patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered via IV infusion weekly over a four-week treatment period (dosage on days 0, 7, 14, and 21).
CytoDyn Receives Positive Response From FDA in Regard to its Phase 3, Registrational Trial in COVID-19 Critically Ill Population
Published: Dec 21, 2021
FDA also allows integrated or meta-analysis of the previous trial results in CD20 final analysis
CD20 is allowed to have four dosages of leronlimab in the first four weeks via IV infusion
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has received a positive response from the U.S. Food and Drug Administration (“FDA”) to conduct a Phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for Invasive Mechanical Ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).
The submission of this protocol was previously announced on December 9th. Patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered via IV infusion weekly over a four-week treatment period (dosage on days 0, 7, 14, and 21).
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