The issue is meeting requirements of a well-controlled clinical trial and demonstrating proper efficacy and safety What NWBO showed was failure to meet the original primary endpoint. Then NWBO tossed out the failed primary endpoint and created a "new" protocol, endpoints, comparator and SAP. Ever biotech is tempted to data dredge their data to find positive outcomes so they can salvage a failed trial.
FDA frowns on that highly. NWBO announced they totally redid the trial in their 3/22 SEC 10K filing, 15 months AFTER they unblinded the data. They know they are rolling the dice, but what do they have to lose as they failed on the original protocol.
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."
Many shareholders already hit the exits as share price is down >50% in the last year AFTER the TLD. If they believed these results were positive, share price would have jumped big time, but it went down.
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