do i think there was cheating in the phase1 trial? i think that might be the explanation for the statistically sig. results but i don't know. only takes 1 patient faking how bad they are, i.e, pretending they are worse than they really are when getting a baseline number to skew the results. you just have to do things a little slower, be a little more clumsy. until the trial administrator describes the safeguards they used to make sure patients were 100% unmedicated when examined, i think there might be a chance of cheating. only takes a tiny tablet swallowed even without water to go within 40min from OFF to ON, even half a pill would show improvement. since each patient was approved for DBS and had to take many of the same tests used in the LCT phase1 trial, did LCT compare baseline scores to see how close they were to the DBS scores?
but the fact that the phase2b results were negative should arouse some curiosity about the phase1 trial. THE 40NTCELL patients got twice the NTCELL packets and they didn't do any better than the placebos in phase2b.
What is missing are before and after videos for the phase1 patients. And if you look at the graphs of the individual patients, the data is all over the map, up, down, up, down, .... why?
and if the patient1 data was removed the phase1 trial would have been a flop imho.
bottom line with no biomarker to show quantitatively there is an improvement, no blood test that shows they are slightly medicated, nothing from LCT on what measures they took to make sure the patients followed protocol, and from that failed pig cell trial where 2 phase1 patients had 50% improvement, i think there is a possibility that the phase1 trial might have been "done better".
