Can't address confounded OS data AFTER the trial. The regulatory application is going to have to address many major trial issues:
1. PFS pseudo-progression after Dr. Liau claimed it was readable by her and her team of clinicians.
2. Tossing out the PFS primary endpoint
3. Naïve OS confounding from the crossover double dosing the treatment arm.
4. Post hoc, data dredged recurrent OS that was not part of the original protocol and was done after NWBO decided to toss the PFS primary endpoint and needed another endpoint.
5. External comparator may not be accepted by the regulators. rGBM p-value is achieved by using a massive external sample size to game the statistics.
6. Regulators have not approved the protocol/SAP as they will wait for the application review.
7. Trial hold -- NWBO never reported the reason that the FDA put a trial hold on their trial. Was it recruiting variations? NWBO had to stop recruiting and ended the trial and FDA released the hold -- but any recruiting issues may still have occurred and is part of the trial. So what really was the issue and why did the FDA find that, or something else egregious, severe enough to intervene and put a hold on the trial.
Yes regulators policies change when you take 16 friggin' years to complete a trial. A whole lot has changed in 16 years.
There IS risk in every stock -- they are risk assets. The risks to be MOST concerned about are deal breaker risks -- the ones that destroy shareholder value and are irreconcilable. In biotech's that is trial issues that would cause regulator's to reject the trial. A RFT or CRL is a significant share price crusher.
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