You are completely disregarding the fact that NWBO worked extensively with the four regulators on the changes they made and the reasons they were necessary. Much was learned in the trial that necessitated these changes and the regulators were well aware of what was happening.
Companies work with the regulators far more than they ever discuss. If they do discuss what's being said, and the regulator finds that it's not being properly represented they can legally say so. This has only been the case since the misrepresentation of what was said in the trial of Erbitux, where BMY signed a major partnership with IMCL based on their misrepresentation. It's the case where Martha Stewart and the CEO of IMCL both did jail time for insider trading when they sold before announcing the FDA's determination that additional trials were required.
I don't believe the FDA is surprised by anything that NWBO has done, they're slow in finalizing their official guidance on trials utilizing historical data, but their new position was clearly stated in the paper published in Annuls of Oncology and that position will eventually be fully documented in FDA regulations. NWBO will do just fine when the have their production facilities established for the U.S. and file with the FDA.
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