NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

biosectinvestor,

I read RMAT when it first came out and it seemed tailor made for NWBO. I believe that RMAT has a reasonable probability of having something to do with what is going on now but in 2015 RMAT wasn’t around, however, orphan status and rolling BLAs were. Maybe orphan status and RMAT is all that is needed to get us where NWBO is now. I do know that RMAT designation actually would improve upon a rolling BLA to shorten up time to patients since much of a rolling BLA is still left to do at the end of a trial and RMAT allows patients to access the treatment while that is being done. In order for access to be granted, though, a decision needs to be made and with FDA being updated regularly from either orphan status priveledge or perhaps a rolling BLA , this decision should have been expedited. Maybe the delay is all related to just RMAT or something else but I think something was being worked out since 2015 and more recently a reported conversation suggested as having taken place pointed to NWBO working on something big and unexpected. In 2015 NWBO made a point of saying that they were giving FDA additional data after the hold and the wording did a good job of providing camouflage in my opinion. We will know “soon” : ).Best wishes.