Saturday, July 25, 2020 6:39:42 AM
I Agree with your remarks as well on NWBO and how it compares to Cel SCI.
The following is my understanding from the back of my head :
NWBO protocol is much more complex than Cel SCI, furthermore primary endpoint is PFS with such problems as how to discard pseudo-progression not as simple as CVM's binary events. In addition their trial design is complex (2/3 - 1/3 in arms) with placebo arm taking drug in the end because of compassionate use or some sort. They had to modify SAP once due to the existance of a marker that might change the conclusions and I believe still in discussion with the FDA as you state to modify the SAP so that some sort of sub-set analysis can be extracted and prove efficacy on some patients with specific markers.... For locking data they need proper analysis of patients samples so that they can identify specific markers and so on and so on... *
Nevertheless : They have 300 or so patients and Cel SCI 3 times more in many locations on the other hand, so Cel SCI timing should not be significantly shorter.
So in conclusion locking db must have been complex and timeline might be a bit more than Cel SCI, 5 months is a hell long, so I am hoping DB Lock will happen in August for Cel SCI (4 months) and they early conclusions (and essential = p value for primary endpoint) from the independant analyst (Cel SCI still blinded) to happen a few weeks after : end of august till mid September.
* This complex and chaotic trial and SAP from NWBO design does not preclude the fact of some expert saying that science is extremely robust and, while bearing some risks , does not preclude of a potential success. I expect NWBO share price to rise from yesterday's low as datalock is announced in 2 weeks time and prior final analysis and a lot of course afterwards if results are conclusive.
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