Exactly! This subtlety is lost on so many because certain assumptions must be made in order to move forward into the last stage of a “subjective” process. Having manufacturing in place is not required for this process but having it there puts the onus on those making the final “subjective” decision about the data and how it is measured/quantified. Leverage is something Linda Powers knows all about and I believe the heat is off of NWBO now and a partner can bolt on this model. A green light for Dr. Linda Liau and journal acceptance based on prior BLA/MAA readiness created by having a manufacturing model in hand is my guess as the initial manufacturing ramp has taken 1+ years to put in place and would have taken significantly longer if Eden wasn’t in place. Any manufacturing news update after the journal article will give a huge lift. From acceptance of the article to the publish date is typically just weeks which coincidentally seems to fit the timing of Dr. Linda Liau’s May 10th presentation and seems to have been predicated on another anticipated event not fully within the control of Dr. Linda Liau or NWBO. Regulator decisions are typically pretty well anticipated and coordination with journals is not unheard of while certification issues are not always easily timed out from what I can tell. Best wishes.
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