Mike, if a company were in a multi-month or year of negotiating an approval, I believe they would also have a clear understanding of where the regulators found their application lacking. While not conceding, as discussions continued, they would be foolish not to also prepare to answer what the regulators are saying are shortcomings with new trials intended to strengthen the data.
In NWBO's case, while money is tight, I still believe that if it's clear more trial data may be needed, without stating why, a new trial would have been started. I believe that NWBO could easily have initiated a trial with either Poly-ICLC and/or Keytruda, either of which could produce dramatically stronger data. These trials are intended to begin after approval, but if it's still being debated, I believe the LP could find a way to fund the trials more immediately.
The fact that this hasn't been done is an indication IMHO that she feels quite certain that approval is coming. She and few others at the company may know that the debate is over the label, tumor agnostic vs brain cancer, I can certainly see the company taking the additional time if there is any possibility of a tumor agnostic label. I'd also point out that if the EDEN is also being evaluated, that may be a part of it, but even if not, it's providing more time for EDEN development.
Gary
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