They would not be changing or adding new patients or adding new "data". Old trials were locked years ago, but they may not have gotten certain data not relevant to approval but relevant to analysis and advancement of the treatment subsequently. NOW was the time to get that data, not later. So for instance, the new definition of GBM. NWBO has that data for its patients. Other trials may have it but it may not have been put in their database. It may or may not be critical for approval, but the reality is that it would be a practical issue for a rare and extremely deadly disease and the FDA would, I expect, understand needing to get such details, and further, it may not be critical for proving something like survival generally, but really be more about a full understanding of the mechanism, and biomarkers that will allow for more precise targeting and label development. It could even lead to a label that was broader than GBM as well. So the FDA and the science might not be as flat and stupid, formalistic and unconsidered as you expect and it might not be data needed for the same things you think, that data might be excluded for approval based on OS, but used for analysis and further study. As I said, the time to get it might likely be now, not later, and I doubt they would do anything that the regulator told them they should not. The reality is, you're not in the room. Neither am I. But I don't presume they are stupid or do things that are against regulation or are likely to get them rejected just to do it. If they are doing anything like that, of course they'd have likely checked with their regulator. You don't just make decisions when dealing with regulators, there is quite frequently a lot of back and forth informally. They can't be held to it, but often the lawyers can have informal conversations. Maybe not everyone knows this, but I know this is the reality with regard to regulatory relations.
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