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jimmy667

08/09/21 2:41 PM

#178033 RE: Black-Ops #178032

Simple. The USA trials they publicly commented on were under powered Phase 2 trials. Now if we get the good and expected results from Brazil they can grant appropriate EUA in USA based on the Brazil results pending a USA Phase 3 designed as a registational trial for full approval. Then all of a sudden FDA goes from pariahs to heros for bringing forth Leronlimab in the pandemic. The Administration's Vaccine goals could also be advanced by using Leronlimab in trials as an adjuvant with the soon to be fully approved vaccines hoping to show greatly increased safety and effectiveness of the vaccine against Delta and Lambda Covid variants. The adjuvant use of Leronlimab with vaccines could be the absolute largest market for the drug. This has not been explored as vaccines are not fully approved yet.
Sleep on that shorts...if you can!
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Cynmark24

08/09/21 3:07 PM

#178037 RE: Black-Ops #178032

How is the USA FDA going to try to get out of this dire position they have established concerning the only drug that saves some patients?

How will the formerly respected agency attempt to regain the trust of Americans



This might sound a bit "political," but I don't believe that it is part of the agenda of the FDA to "regain the trust of American," as it is clear that they have their own agenda as directed by their Board members who come from Big Pharma. They only care about themselves (i.e. lining their own pockets), thus gaining the "trust of Americans" is really very low on their food chain as it just does not concern them.