Friday, April 23, 2021 8:09:40 AM
100% FDA - 100% correct!
And to change the dosage mid-trial there has to be a strong signal that the design dosage is not working at all, which was not the case as we learned.
Much further down the trial timeline, and with a larger patient population which also included a more diverse set of health conditions and outcomes, the evidence became clearer regarding the difference dose 3 & 4 make.
- FDA disallowed it at first
- It severely impacted trial outcomes (and more importantly patient lives)
- FDA washes hands and no one can be held accountable (or will come forward and BE accountable)
We move on to other designs while whistling a tune as if nothing happened.
MH
And to change the dosage mid-trial there has to be a strong signal that the design dosage is not working at all, which was not the case as we learned.
Much further down the trial timeline, and with a larger patient population which also included a more diverse set of health conditions and outcomes, the evidence became clearer regarding the difference dose 3 & 4 make.
- FDA disallowed it at first
- It severely impacted trial outcomes (and more importantly patient lives)
- FDA washes hands and no one can be held accountable (or will come forward and BE accountable)
We move on to other designs while whistling a tune as if nothing happened.
MH
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