The Risk Factors section is about all the things that could possibly go wrong. It is also explained in that section how they revised the Statistical Analysis Plan (SAP), as it is in their presentation of final data. It is also clarified there and in previous Annual Meeting where there are notes and referenced in various places including a PR a year or so before data lock that they were busy revising the SAP, and of course that was before unblinding and is completely acceptable to the relevant regulatory agencies. The acceptance by the EMA and MHRA were documented on the government kept websites indicating that they had sought approval before unblinding to the company and their strategy for application had been fully disclosed in the previous Annual Meeting notes people took and posted.
Many of us participated in that broadcast meeting remotely.
So no, you’re wrong about the history. But you can keep saying what you want to say and emphasize what you want to emphasize, but they history of the trial and they way they addressed the challenges is in the presentation which is recorded. Aspects of the issues and then the fix were discussed over a few years prior to data lock. They did not need to be unblinded to know there would be a challenge with crossover with a successful drug. The FDA knows that too, as discussed in their paper discussing the reasons for external control arms and the entice of such trials.
The FDA does not require companies to have unethical trials in order to get approved.
Also, PFS is a surrogate for Ongoing Survival (OS), but OS is a real endpoint measure, not a statistical surrogate for a measure, according to the regulators, and it is the gold standard of measures because it is not a statistical surrogate to measure survival, it IS survival. It can't be manipulated in a disease like this. This disease is nearly 100% lethal in a short period of time. When survival exceeds that time for the standard of care, and where there are no very good treatments or there is no standard of care, as for recurrent GBM or the treatment substantially improved quality of life AND extends patient survival, even a single arm trial will likely be very compelling, as the PIP documents suggest, which also, according to the company, would further contemplate an ECA and is an approved replication of the trial that you suggest is unacceptable.
The regulators are sending a strong message with that PIP approval.
So it is very unlikely your theory and posts will be a good predictor of the final outcome here, IMHO, but just offer distractions and noise.
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.
