Every time I suggest that NP get aggressive with t
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Posted On: 06/07/2021 3:33:34 PM
Every time I suggest that NP get aggressive with the FDA, get all of these dislikes. Who are these people, maybe that don't want to force an approval.
Biogen gets an approval but wants to run a trial with a higher dose, so why can't we get the same approval. Put into the FDA a request for the exact same deal, and do it in public, and notify your local Congressmen of your intent. I suggested hardball to NP to unblind at CD10 and CD16 when remdesivir was approved. We keep on back pedal mode and this results in that hit job FDA letter. I want to call the FDA out because the other way is NOT, NOT working.
"Go back to the FDA and ask for the Biogen deal where the F.D.A. granted approval on the condition that the manufacturer, Biogen, conduct a new clinical trial! NP, the FDA works for you, not the other way around, the FDA is beholden to taxpayers. Publicly ask the FDA for an EUA to conduct a 4 dose critical trial."
Biogen gets an approval but wants to run a trial with a higher dose, so why can't we get the same approval. Put into the FDA a request for the exact same deal, and do it in public, and notify your local Congressmen of your intent. I suggested hardball to NP to unblind at CD10 and CD16 when remdesivir was approved. We keep on back pedal mode and this results in that hit job FDA letter. I want to call the FDA out because the other way is NOT, NOT working.
"Go back to the FDA and ask for the Biogen deal where the F.D.A. granted approval on the condition that the manufacturer, Biogen, conduct a new clinical trial! NP, the FDA works for you, not the other way around, the FDA is beholden to taxpayers. Publicly ask the FDA for an EUA to conduct a 4 dose critical trial."
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