The primary endpoints were not tossed out post hoc, they discussed it with all of their regulators and applied before they unblinded. Restating false “facts” is not sticking to the facts. It is misinformation.
As for the change, the PFS measure as it was at the time of the start of this trial, and the baseline measure for PFS is now changed for neurooncology trials to 6 months later with more care, was unfit for the purpose. Since the purpose of PFS intimately, as an actual surrogate measure for OS is to correlate with proving OS, the FDA typically uses it for accelerated approval, and then requires that companies prove that correlation afterwards with a confirmatory Phase 4 trial.
In fact, by making the primary measure what was previously their secondary measure but is the preferred OS measure and skipping any attempt at an accelerated approval, they’ve done exactly what was appropriate and required.
Further, since this is almost always fatal, a significant change in survival statistics is simply not going to be discarded by any regulator. Numerous experts in the field have suggested this is the case in private posts on their own social media accounts.
Yes, publication is pending. Validating such incredible results should be done with care and I am sure that care is likely being applied. But there are those who I am certain will not care when that validation comes out and will persist in making false claims to discredit the treatment, research and company while sidestepping saying anything real at all about those who actually conducted the research because they know that huge forces would absolutely crush them.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
AI
