Hopeforthefuture3,
NWBO was asked long before about updating the clinical trials site and they discounted it as just a clerical issue. I never bought that. They had to have been advised that they should not do this until “the process” of clarifying need for the changes was made public. The fact that FDA promised ECA guidance in stone last December and still have not done this points to this as that guidance would have given NWBO cover for making the changes without a legal challenge. There is a process outlined for making changes to guidance and a process for exceptions to adequate and well controlled trials and I believe that FDA ECA guidance was not published because it would be viewed as favoritism being shown to NWBO’s Phase 3 trial before their ECA use and the SAP were formally validated, “approved” in practice, not “accepted” in theory by following the guidance in the exceptions to adequate and well controlled trials. Approval of the use of those exceptions (ECAs) and SAP as “adequate” for THIS trial ONLY happens with approval of the BLA. This is what FDA May have been reminded of when stating they would update guidance sooner than the BLA decision for this trial. I defer to legal counsel but my due diligence points directly to this being the case. Best wishes.
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