Doctor580 wrote:
Given our results showing a Clinically significant decrease in mortality and the fact that cd-12 is now OLE bc of this and we have eind we won't get any pts who want to enroll in a double blind study and even if we did it's UNETHICAL!!!! This is why the CD-12 is now OLE!!!....this is also why the fda changed the endpoint to length of stay and not mortality bc if/when it proves AGAIN to decrease mortality they could be blamed for knowingly harming the control group. Please someone have them address this issue during the q and a bc I'm about to lose my xxxx and so are a bunch of my colleagues.
my response:
Brillitant of the FDA, anticipating we would meet the mortality Endpointin the 140 patient trial and then they could be blamed for massive death, that they skeem to tempt us with an easy Endpoint to reach (easy based upon our existing data), "length of stay in hospital", and brilliant of Doctor580 to pick up on that.
Truly the FDA can be blamed now, and will be by honest informed folks, they are to blame for massive, hundreds of thousands of deaths, they should have given a EUA in May, when LL eIND cases were very compelling, safety was known, and Dr Patterson on TedTalks told the world LL was a cure. "May be effective & safe" the FDA says, and you get an EUA. Looks at us now, "Is Effective and Is Safe" but no EUA. Why? The FDA is putting other interests above deaths, very risky, immoral, unethical, sad, corrupt, wrong. pathetic.
Critical folks now, many destined to die, cannot get a life saving drug that shows overall 24% reduction in deaths vs the best drugs available/approved.
Critical folks 65 or younger now, many destined to die, cannot get a life saving drug that has a p value of 0.03 and has displayed a 30% reduction in deaths vs the best drugs available/approved.
Given our results showing a Clinically significant decrease in mortality and the fact that cd-12 is now OLE bc of this and we have eind we won't get any pts who want to enroll in a double blind study and even if we did it's UNETHICAL!!!! This is why the CD-12 is now OLE!!!....this is also why the fda changed the endpoint to length of stay and not mortality bc if/when it proves AGAIN to decrease mortality they could be blamed for knowingly harming the control group. Please someone have them address this issue during the q and a bc I'm about to lose my xxxx and so are a bunch of my colleagues.
my response:
Brillitant of the FDA, anticipating we would meet the mortality Endpointin the 140 patient trial and then they could be blamed for massive death, that they skeem to tempt us with an easy Endpoint to reach (easy based upon our existing data), "length of stay in hospital", and brilliant of Doctor580 to pick up on that.
Truly the FDA can be blamed now, and will be by honest informed folks, they are to blame for massive, hundreds of thousands of deaths, they should have given a EUA in May, when LL eIND cases were very compelling, safety was known, and Dr Patterson on TedTalks told the world LL was a cure. "May be effective & safe" the FDA says, and you get an EUA. Looks at us now, "Is Effective and Is Safe" but no EUA. Why? The FDA is putting other interests above deaths, very risky, immoral, unethical, sad, corrupt, wrong. pathetic.
Critical folks now, many destined to die, cannot get a life saving drug that shows overall 24% reduction in deaths vs the best drugs available/approved.
Critical folks 65 or younger now, many destined to die, cannot get a life saving drug that has a p value of 0.03 and has displayed a 30% reduction in deaths vs the best drugs available/approved.
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