Pathetic, & Ridiculous.... Good & Bad Outlook
IMO, the good is that the door is still very wide open for a s/c therapeutic.
IMO, the bad is that the FDA and DSMC are without a doubt, have just got to be corrupt. "Come on man!"
The bad is revealed (again) in the pathetic approval of LLY for m/m, and thus, the implication is that they will do the same for a big pharma with a s/c therapeutic, waiting, ignoring little (no influence in high places) Cytodyn.
Lilly's approval (pathetic & ridiculous as 123kdc so accurately submitted)
this approval was based upon nothing, empty air, nothing burger, crap.
"The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo.
Most patients, including those receiving placebo, cleared the virus by day 11.
(So Primary Endpoint being incredibly terrible, placebo did as good as drug)
However, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment. For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients."
(Secondary Endpoint is reduction in ER & hospital visits, for m/m???)
"Come on man". Based on htis Secondary Endpoint they get an EUA and we did not with our m/m resutls?
Embarrassing for the FDA, for the DSMC, for America?
Lilly EUA just after the election? PFE/BNTX results held until after election?
Some are saying that it is now clear that the FDA has displayed a strong out of control preference to money/power vs allowing people to die.
IMO, the good is that the door is still very wide open for a s/c therapeutic.
IMO, the bad is that the FDA and DSMC are without a doubt, have just got to be corrupt. "Come on man!"
The bad is revealed (again) in the pathetic approval of LLY for m/m, and thus, the implication is that they will do the same for a big pharma with a s/c therapeutic, waiting, ignoring little (no influence in high places) Cytodyn.
Lilly's approval (pathetic & ridiculous as 123kdc so accurately submitted)
this approval was based upon nothing, empty air, nothing burger, crap.
"The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo.
Most patients, including those receiving placebo, cleared the virus by day 11.
(So Primary Endpoint being incredibly terrible, placebo did as good as drug)
However, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment. For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients."
(Secondary Endpoint is reduction in ER & hospital visits, for m/m???)
"Come on man". Based on htis Secondary Endpoint they get an EUA and we did not with our m/m resutls?
Embarrassing for the FDA, for the DSMC, for America?
Lilly EUA just after the election? PFE/BNTX results held until after election?
Some are saying that it is now clear that the FDA has displayed a strong out of control preference to money/power vs allowing people to die.
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