It was very clear to investors that NWBO was working with all 4 regulators on creating and gaining their acceptance of a new SAP prior to locking the trial. I feel certain that this took far longer than they originally anticipated, but in the end all 4 regulators agreed and I'm sure the issues you're discussing were very apparent to all of them.
No, NWBO has never told investors about all the discussions they've had with the regulators, I don't believe that any other Biotech or BP does either, but you can bet the FDA knows all about it and has concurred with the direction the company has taken. The article written purely by FDA staff, including Dr. Padzur, in Annuls of Oncology clearly indicates the direction the FDA will be taking in the future and while that policy hasn't yet been made official, I don't believe they'll have a problem reviewing the BLA submitted by NWBO that's largely based on what's in the Annuls publication.
Gary
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