No, 16 years and 86 trial sites. CRO's audit trials as does the FDA. The issue is the failure to meet the endpoint, rejecting it, replacing the protocol, endpoints, comparator and SAP. Second is the confounding of the naive OS data. NWBO repeatedly reported it but yet still reporting the data. The post hoc, data dredged recurrent OS arm.
All of this trial manipulation, the confounding raises issues with the validity of the trial data. FDA highly frowns on trial manipulations as they have seen many a biotech with failed trials try to spin positive data out of the trial some how salvage it.
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