OK i'm handwaving here but I really think it'll come down to what Axel Hoos was saying in that talk. Inflammation looks like progression on a scan according to both Macdonald and RANO (not sure which they're using). Assuming PFS failed I'm hoping they've thought this through and have a plan. If this is the case, convincing data to show to the FDA could include demonstration that this is typically pseudoprogression. I assume they are monitoring the tumours in these patients semi-real time so after progression they can show that months down the line that progression reverts.
I think in several years once the field has matured a bit it will become clear that progression is the absolute worst endpoint to use in an immuno oncology trial.
"cash"
yes this is a big issue (not sure about how much they'd need to get to approval)...but if they can show a good stat. sig. OS HR with a convincing argument for why PFS failed (assuming it failed) and why this has minimal influence on clinical relevance this increases the chances of approval and the value of the company... the SP should pick up allowing for dilution (I hope!). On a related note do you know who pays for treatment of the remaining patient's upon completion of the trial? would NWBO continue to pay and accrue info or would their cash burn go down significantly? I have no idea about this stuff.
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