They have already re-reviewed PFS -- starting at minimum in mid-November. They might still be re-reviewing (I think they are probably done). The other data collection apparently started in Mid November 2018. The curveball they threw was not the data collection. The curve ball they threw is the "ginormous" SAP finalization they are conducting simultaneously. The data is frozen to approximately November for the final statistical analysis, although an update would be provided thereafter based upon further blinded data now/still accumulating.
NWBO states it will submit a "ginormous" final SAP revision to four countries once they are ready. They never explained this before, even though they were supposedly going to final data lock in 2017 and 2018. In 2018, they got to the equivalent of data lock from about the middle of April to late October early November. They do that again, and they'll be ready for industry expert theater at ASCO (no presubmitted abstract required). If they are not ready, they'll likely blame regulators for not getting the SAPs back from all four countries.
(Management bemoan what many here otherwise feel are more than fair paychecks. They essentially curse them. Nonetheless they are still collecting them month after month. False horizon after faux finis.)
Board member JJ (a manufacturing expert -- which is an understatement), a relatively quiet individual at ASM meetings in the past, stated NWBO will start talking in about three to four months. I assume this is when he projects the regulators from all four countries might be finished (aka: approve or deny) with the SAP revision/finalization submissions, and NWBO will be more free to discuss commercialization timeline if successful.
We'll see.
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