Listening to the conference call and SI speaking...he refuses to do an RCT (8:45 in the call)...SI still wants to argue a point with the FDA who has been consistent in saying that they wanted a double sided with placebo.
NOW Bell potter analyst remonstrated that the FDA keeps moving the goal post...(15.10). i dont think they moved the goal posts since Oct 2020 (BP)...its moreso us in MSB not complying with the fact that we need to follow their FDA requirements...our argument that its ethically unfair to test our therapies on the most sickest of patients at <12 years old or adults that have no other path to resolve AGVHD - the FDA didnt/doesnt care. They wanted full blown science results for a long time, there wasnt any budging on this...
Now we have no path...no funds. thats on the Board...
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Listening to the conference call and SI speaking...he refuses to...
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