NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

If it's not AA or EAMS or FAST TRACK, and if there not quite done enrolling, is there a remote chance that maybe they're amending the age criteria near the end of the study to include children? And if so, they're going to regulators with overall safety data to expand to include that GBM market...

Here's my thinking, for the first time this year, their SEC statements reference GBM in children. This leads me to believe they're thinking about that market, and they're thinking about it now. If let's say the study enrollment is around 320-330, near complete, and they decided to temporary halt screening to see if they can get the regulators okay to expand the age criteria. If regulators come back with a yes, then they only recruit children for those last 18-28 enrollment slots (depending on how many they think they need). No need to do a follow up study for that GBM market if they do that. They're already looking at results based on age, so it wouldn't be much of a change to analyze that young age cohort too. They will would end up hitting their primary endpoint next year, all adults and children would crossover to vaccine once results come in assuming a success. But being that the primary endpoint is expected early next year, not as many children would have to wait to move over to treatment as they'd be last in the trial and possibly only need to be a few months on placebo before the study ends. Expanding the age would be really good news to me too. :)

Feel free to veto it. Just thinking out loud.