sean007 wrote: You pose a logical question.. has
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Posted On: 01/17/2021 12:52:21 AM
sean007 wrote:
You pose a logical question.. has a lot of merit.....But to define the efficacy of any drug...and it's behavior etc... you need comparative clinical evidence......hence the CD12...we have anecdotal evidence coming out of our A$$...No one cares......sometimes in life, ...people have to be martyred to give any drug the necessary gravitas....to be adopted by the medical community and lastly dosed to the public.....personally I am in the early age group of subjective martyrs......better us than Children.....the FDA doesn't care about the available pool..they want results.
To sean007:
With my sincere respect for you but not for the FDA or Fauci nor for most politicians, I disagree with the general attitude above supporting behavior and decisions (during a pandemic of this magnitude) that actually are responsible for massive deaths. The level of creative innovative adaptive thinking has earned the FDA an F+ grade from this Chemistry Professor.
"May be effective" says the FDA.
Is leronlimab safe?
The Bottom Line is it's all about risk vs reward. The risk of approval of leronlimab in April for an EUA (stretching protocol because of a potentially devastating pandemic) was what, the risk was very very low. Our eIND data was excellent and safety was known to be pristine, even reducing SAE/AEs.
The FDA is not the only group in blatant denial. When disasters grow gradually, people commonly maintain inappropriate hope and their denial also commonly grows in small increments, then at some point we wake up to see what's happening. But regardless, considering...
1) the magnitude and potential of the covid-19 pandemic (now an endemic)
2) our April/May 2020 eIND data "may be effective"?????????????
3) our HIV safety data
4) the predicted death rates back in March then April then in May
5) our Mild Moderate Phase II "Clinical Significance" & "Statistical Significance"
6) Phase III s/c Interim Data seen by the DSMC (and FDA?) @ 50% enrolled
7) Dr Bruce Patterson's Ted Talk presentation (in April?)
I'd love to educate America with a 3 hours seminar, discussing why the FDA has their existing protocol for EUA approvals, and then elaborate on all 7 points above, and then take a poll to evaluate how Americans feel about the FDA and all of the deaths in America.
You pose a logical question.. has a lot of merit.....But to define the efficacy of any drug...and it's behavior etc... you need comparative clinical evidence......hence the CD12...we have anecdotal evidence coming out of our A$$...No one cares......sometimes in life, ...people have to be martyred to give any drug the necessary gravitas....to be adopted by the medical community and lastly dosed to the public.....personally I am in the early age group of subjective martyrs......better us than Children.....the FDA doesn't care about the available pool..they want results.
To sean007:
With my sincere respect for you but not for the FDA or Fauci nor for most politicians, I disagree with the general attitude above supporting behavior and decisions (during a pandemic of this magnitude) that actually are responsible for massive deaths. The level of creative innovative adaptive thinking has earned the FDA an F+ grade from this Chemistry Professor.
"May be effective" says the FDA.
Is leronlimab safe?
The Bottom Line is it's all about risk vs reward. The risk of approval of leronlimab in April for an EUA (stretching protocol because of a potentially devastating pandemic) was what, the risk was very very low. Our eIND data was excellent and safety was known to be pristine, even reducing SAE/AEs.
The FDA is not the only group in blatant denial. When disasters grow gradually, people commonly maintain inappropriate hope and their denial also commonly grows in small increments, then at some point we wake up to see what's happening. But regardless, considering...
1) the magnitude and potential of the covid-19 pandemic (now an endemic)
2) our April/May 2020 eIND data "may be effective"?????????????
3) our HIV safety data
4) the predicted death rates back in March then April then in May
5) our Mild Moderate Phase II "Clinical Significance" & "Statistical Significance"
6) Phase III s/c Interim Data seen by the DSMC (and FDA?) @ 50% enrolled
7) Dr Bruce Patterson's Ted Talk presentation (in April?)
I'd love to educate America with a 3 hours seminar, discussing why the FDA has their existing protocol for EUA approvals, and then elaborate on all 7 points above, and then take a poll to evaluate how Americans feel about the FDA and all of the deaths in America.
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