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Posted On: 08/02/2022 8:02:30 PM
Post# of 148898
Perhaps we’re pontificating on disparate facets of Cytodyn’s history. Sounds like you’re noodling on FDA not granting EUA for Covid, and I dare say conspiratorially so. May be.
However, I am pontificating on the missing aggravated safety data, quite possibly across multiple clinical trials stewarded by Amarex. Particularly, I'm thinking of the FDA’s reticence to accept promotional statements of Leronlimab’s safety after being denied said safety data, and its willingness to write a letter to Cytodyn stating that we must stop promoting our safety. Even more particularly, I'm thinking of what difference that could make if, in fact, this facet has been cured.
“Safe, check; possibly effective, check.“
But according to the top of Cytodyn’s website.
“On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab. Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication.”
If as you say “Check”, then as I say, much could be clarified “Immediately.”
Damn, my gray matter hurts now. Off you go. Good luck.
However, I am pontificating on the missing aggravated safety data, quite possibly across multiple clinical trials stewarded by Amarex. Particularly, I'm thinking of the FDA’s reticence to accept promotional statements of Leronlimab’s safety after being denied said safety data, and its willingness to write a letter to Cytodyn stating that we must stop promoting our safety. Even more particularly, I'm thinking of what difference that could make if, in fact, this facet has been cured.
“Safe, check; possibly effective, check.“
But according to the top of Cytodyn’s website.
“On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab. Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication.”
If as you say “Check”, then as I say, much could be clarified “Immediately.”
Damn, my gray matter hurts now. Off you go. Good luck.
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