Mixed reactions to this one…
The FDA would approve anything that brings money to their basket. They approved Pfizer’s COVID-19 jab without any studies or research on the potential side effects. The vaccine was made in a few months and the FDA says it’s fit for global use.
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Now they have denied emergency clearance for lenziluman. It’s a monoclonal antibody treatment. Why did they do this? No response…
They approved Pfizer, but denied this?
How come?
Joe Rogan announced that the monoclonal antibody treatment has helped him fight COVID-19.
BREAKING REPORT: FDA Denies Emergency Use Authorization for New COVID-19 Drug lenzilumab..
— Chuck Callesto (@ChuckCallesto) September 9, 2021
With all due respect @DrWoodcockFDA, would you please be so kind Ma'am and explain what made the @US_FDA believe that the benefits of @humanigen's #lenzilumab do not outweigh the risks? A response would be highly appreciated pic.twitter.com/B7HHgw9pAO
— RedFox🦊 (@TheTr8er) September 9, 2021
The Epoch Times shared parts from the letter from The FDA:
“In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,” the Burlingame, California-based firm said in a statement.
The head of Humanigen, Cameron Durrant, said that the company plans to keep trying to develop the drug.
“We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an [emergency use authorization] to treat hospitalized COVID-19 patients,” he said.
Someone is lying here…
“FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.”
Is it safe or not? @humanigen $HGEN pic.twitter.com/4GiRnB1Tvh
— Mosaic Theory (@MosaicTheory101) September 9, 2021
This is why Variant Agnostic Therapeutics like Lenzilumab with proven in a Phase III results that it prevents progression to Ventilation in Covid-19 need to be authorized for emergency use to save lives & stop ICU burden. #Covid_19 #DeltaVariant #humanigen #HGEN #Lenzilumab https://t.co/LuqghlWFSm pic.twitter.com/5ztg6P9AJ7
— Knuckle Sandwich (@KnuckleSandwic8) September 7, 2021
Reuters offered more:
Humanigen expects an ongoing study to provide additional safety and efficacy data to support its new EUA request.
The company filed its application with the FDA for emergency use of the drug in May, citing late-stage trial data.
Humanigen also started the process of UK authorization for the drug in June through a rolling review submission.
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Source: WeLoveTrump
