But yet the protocol, comparator, endpoints and SAP were all manipulated and materially different than the original trial protocol, comparator, endpoints and SAP.
The trial was a naive GBM trial and suddenly they post hoc data dredge a recurrent GBM endpoint!!! That is sure manipulating a trial protocol.
FDA is very anal about protocol compliance and trial design compliance. And NWBO changed everything.
Even NWBO admits it. They didn't have a choice as the PFS failure would have likely ended everything for them. So they completely redid everything post hoc. As NWBO stated in their SEC filing: "There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."
Even the company has TOLD you that this is high risk of failing. But denial is hard for some investors to deal with.
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