Changing an SAP post hoc has significant questions as to the viability of the trial. Post hoc analysis is used to inform future trial, NOT for regulatory approval. Especially for the post hoc, data dredged recurrent OS arm.
Post hoc protocol, endpoints, comparator and SAP changes are unheard of and something highly frowned on by regulators -- it is changing the rules after the game is over.
Read the Journal of Neuro-Oncology Editorial that aggressively criticizes many of the NWBO trial practices that raise validtiy questions about the results, ethics questions about Dr. Bosch's role as Corresponding Author while he is an employee and major shareholder, among other issues. Other neuero-oncologists are questioning the trial also in the Comments attached to the JAMA Oncology publication -- read that too.
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