You want my opinion MarcS? Simple, fda or those in the agencies knew if they have us 4 doses and kept the 28 day all cause mortality in the protocol, they knew that Leronlimab would of slammed it out of the park. So, they restrained us from doing it. To me, this makes more sense than a dollar and is the main reason to stop CYDY from gaining a foot hold in the Gilead's brain trust club.
Again, that is why I think this happened and then the fda letter a couple days ago they tried to nail the coffin shut for us.
MarcS's quote:
Quote: By the way, the company had ALSO initially proposed 14-day mortality as the primary endpoint – again nixed by the FDA.
I recall that they increased the trial primary endpoint from 14-days to 28-days, and made 14-days a secondary endpoint, upon advice given to them by somebody. I don't recall who it was, or even if they disclosed who gave the advice.
But, I wonder why this is not talked about more. Had they been given 4 weekly doses, instead of just 2 weekly doses, this probably would have been a non-issue.
But, the real question is why were they told to increase it from 14-days to 28-days, at the same time as restricting the doses to days 0 and 7.
FDA or Amarex, whoever gave them this "advice" is likely incompetent or corrupt.
What was the thought process of going from 14-days to 28-days without increasing the doses? That explanation could weed out which it is, incompetence or corruption or something else.
GLTU MarcS and all the longs for has John Paul Jones said a couple centuries ago, "I have yet begun to fight," And Cytodyn has also just begun to fight over seas. I am just waiting for all this to play out with PI, India and Brazil so hang on to your boot straps fda and don't bend over!
HCIT
Again, that is why I think this happened and then the fda letter a couple days ago they tried to nail the coffin shut for us.
MarcS's quote:
Quote: By the way, the company had ALSO initially proposed 14-day mortality as the primary endpoint – again nixed by the FDA.
I recall that they increased the trial primary endpoint from 14-days to 28-days, and made 14-days a secondary endpoint, upon advice given to them by somebody. I don't recall who it was, or even if they disclosed who gave the advice.
But, I wonder why this is not talked about more. Had they been given 4 weekly doses, instead of just 2 weekly doses, this probably would have been a non-issue.
But, the real question is why were they told to increase it from 14-days to 28-days, at the same time as restricting the doses to days 0 and 7.
FDA or Amarex, whoever gave them this "advice" is likely incompetent or corrupt.
What was the thought process of going from 14-days to 28-days without increasing the doses? That explanation could weed out which it is, incompetence or corruption or something else.
GLTU MarcS and all the longs for has John Paul Jones said a couple centuries ago, "I have yet begun to fight," And Cytodyn has also just begun to fight over seas. I am just waiting for all this to play out with PI, India and Brazil so hang on to your boot straps fda and don't bend over!
HCIT
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