I really do believe that Bio's sentiment that NWBO is struggling with the timeliness to assemble the placebo arm based on historical trial data (not DCVax) is the high likelihood of where this is caught up. This is also likely why Stupp has joined the NWBO consulting team to assemble this specific data. If you take a step back and think about it, why would these clinicians have incentive to 'rush' to getting this data when they have their own world to tend to. I know they all care about the patient care advancement, but they might not even know about the potential of DCvax. I do believe the world is easing up in terms of COVID and I'm hopeful that will speed up the process a bit for them.
Looking at it from the NWBO management lens, I'm sure it's equally frustrating for them as well if they're not getting buy-in from the people that hold the keys to the historical trial data they need to finalize TLD and they have all of us banging down their door everyday and can't say anything about it.
I do not believe the hold up has anything to do with really much else that has been suggested here, including: presentation alignment, journal pushback, Flaskworks certification, BLA submission, regulatory approval, etc.
I do believe however that NWBO is using this time wisely to redirect efforts to other initiatives that will fast track approval and shorten the window from TLD announcement to RA approval.
To be clear, I'm equally as frustrated with everyone here as I have been invested for many years and major % of my portfolio is tied up in NWBO, most of which has been bought in the 1.20-1.43 range - but as many have shared, I know we will be successful in the end.
