Statistically manipulating endpoints is not uncommon. The challenge is properly rationalizing the statisitics to satisfy the FDA. Trying to statistically compensate for confounded data -- the double dosing on most of the treatment arm, will be interesting. They didn't screen the external comparator trials for dosing schedule to have a fair comparison. So they were left with trying statistical magic.
Sorry, FDA only rarely intervenes in clinical trials with holds. But NWBO has refused to identify the reason and they ended the trial prematurely without remedying the hold as the FDA let them. Nobody knows as NWBO won't tell and FDA doesn't go public with the reason.
FDA ALWAYS monitors clinical trial real time. It could have been unexplained deaths, it could have been recruiting/screening issues. Either way -- it is material and should be reported to shareholders. It has nothing to do with some other trial as it was in 2015 and there weren't other NWBO trials.
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