Sunday, May 07, 2023 1:55:34 PM
Codycrusher wrote: ?Sun May 07, 2023 6:47 am
Won’t the trial on ctdg also be updated every time you treat a patient so patient 1 we will know when he or she is treated and than patient 10 it will be updated Everytime you finish treating a patient, but I am curious will you be updating us on the patient treatment status successful or failure as the trial is ongoing or will that be a all at once update regarding treatment status once all patients are treated and than you file for BLA;;;
Cody we will provide whatever the reg's require us to but there will be no specific patient detail. These are critically ill patients and have at best 2 or 3 days to turn around or they die. This isn't cancer. In the phase 2b we had a very high survival rate of 100% in patients under 85 and 91% over 85. Why? Two reasons; 1) a patient died of cardiac arrest (87yrs old, with cardiovascular disease, mechanically ventilated in ICU in acute lung failure) and the other also over 85 discharged himself 7 days after 2nd transfusion and because he was not there to meet end point of 28 days his data was censored.
The published final results is all that matters because no conclusions can be made until after end point is reached and data analyzed so we all wait together. Keep in mind that somewhere around 38-40 of the 64 placebo patients will die. Of the 40% we anticipate surviving on standard of care, 30% of them will suffer traumatic brain injury.
https://forum.therapeuticsolutionsint.com/viewtopic.php?f=2&p=19116#p19116
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