(Total Views: 929)
Posted On: 11/10/2020 8:10:48 AM
Post# of 155038
So, Eli Lilly's Bamlanivimab gets EUA:
So their initial primary end-point which was viral load reduction (yes the one that Patterson measured as occurring with LL) was not achieved:
Also there is no difference observed with different dosages 700
2800, 7000, placebo). This is normally a red flag.
However, the FDA gives Bamlanivimab an EUA in basis that it MAY be effective, yes, it MAY be effective:
This is disgusting. We were effective, and in NEWS-2 a very well documented assessment protocol ascertaining the possibility of progression (high risk for disease progression) . And not only we were affective we were statistically effective by Pete’s sake.!!!!
Yet we don’ t get EUA and they do..
However, we are in a very good shape as we are the only ones (that I am aware of) going for S/C. In a way, having the cojones to go for it might show to be the right decision.
Winners are those who dare. We did and are the only game on town.
I won’t make any comments about our corrupt regulatory bodies as I want today to be a good day.
Quote:
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. Among patients who were at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients compared to 10% in placebo-treated patients.
So their initial primary end-point which was viral load reduction (yes the one that Patterson measured as occurring with LL) was not achieved:
Quote:
Most patients, including those receiving placebo, effectively cleared the virus by Day 11. The effects on viral load and on reduction in hospitalizations and ER visits, and the safety profile, were similar in patients receiving any of the three bamlanivimab doses.
Also there is no difference observed with different dosages 700
2800, 7000, placebo). This is normally a red flag.
However, the FDA gives Bamlanivimab an EUA in basis that it MAY be effective, yes, it MAY be effective:
Quote:
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.
This is disgusting. We were effective, and in NEWS-2 a very well documented assessment protocol ascertaining the possibility of progression (high risk for disease progression) . And not only we were affective we were statistically effective by Pete’s sake.!!!!
Yet we don’ t get EUA and they do..
However, we are in a very good shape as we are the only ones (that I am aware of) going for S/C. In a way, having the cojones to go for it might show to be the right decision.
Winners are those who dare. We did and are the only game on town.
I won’t make any comments about our corrupt regulatory bodies as I want today to be a good day.
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