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Posted On: 12/15/2021 2:33:14 PM
Post# of 148870
DSMC simply tried to do what it was chartered to do: periodically check on the safety of the study. It also has an obligation to stop a study for overwhelming benefit or futility, and even more rarely to recommend changes to a study, but 90% of the time they just say continue on as planned. That's what happened on DSMC interim reviews in CD12.
The +65 was a self-imposed mistake, not to stratify for age. I think Lalezari admitted as such recently in his letter, if I recall correctly.
The business with 4 shots vs. 2 I agree, the FDA screwed us there. The problem is when you give a beaurocrat some power, they are going to use it, whether they know what they are doing or not. Every Tom, Dick, and Harry government worker knows best and has the authority ...
So ya, I'm not thrilled with FDA either. First of all, I heard they said "No" to LL in Covid because they had no idea of its immunomodulatory function. Then they are telling us how to dose? The simplest explanation is ignorance and too much power with FDA, not malicious intent to keep good drugs from the public or to keep an upcoming drug developer down.
I agree the FDA stuff with the letter and removal of video was over the top and completely unnecessary. I blame it on a big ego beaurocrat with too much power.
If you are saying the DSMC had a duty to notice the disparity in age in each group and that critical subjects were doing very well vs. placebo in the first 2 weeks vs. the weeks 2-4 and to recommend changes to dosing, I disagree. I don't think that is part of what the DSMC is tasked to do.
Recknor described some of the back and forth with FDA on LH protocol in yesterday's call. He said 3 divisions are giving feedback. Good or bad for us?
Hard to say. It slowed us down, but perhaps there were some good ideas that will help us, too.
The +65 was a self-imposed mistake, not to stratify for age. I think Lalezari admitted as such recently in his letter, if I recall correctly.
The business with 4 shots vs. 2 I agree, the FDA screwed us there. The problem is when you give a beaurocrat some power, they are going to use it, whether they know what they are doing or not. Every Tom, Dick, and Harry government worker knows best and has the authority ...
So ya, I'm not thrilled with FDA either. First of all, I heard they said "No" to LL in Covid because they had no idea of its immunomodulatory function. Then they are telling us how to dose? The simplest explanation is ignorance and too much power with FDA, not malicious intent to keep good drugs from the public or to keep an upcoming drug developer down.
I agree the FDA stuff with the letter and removal of video was over the top and completely unnecessary. I blame it on a big ego beaurocrat with too much power.
If you are saying the DSMC had a duty to notice the disparity in age in each group and that critical subjects were doing very well vs. placebo in the first 2 weeks vs. the weeks 2-4 and to recommend changes to dosing, I disagree. I don't think that is part of what the DSMC is tasked to do.
Recknor described some of the back and forth with FDA on LH protocol in yesterday's call. He said 3 divisions are giving feedback. Good or bad for us?
Hard to say. It slowed us down, but perhaps there were some good ideas that will help us, too.
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