I see the mfg steps taken in the UK but I was trying to figure out whether NWBO was waiting for the peer review of the clinical data to then submit their BLA or if they had a rolling review in the UK and are actively engaged in the submission process or lastly, have already submitted their entire BLA.
I am not as sure they have submitted, at least not completely, though I know the length of time that has elapsed would lead me to believe they have at least prepared it and quite probably submitted it or possibly well along in the midst of a rolling submission process now. I was trying to figure out based on any labeling clues whether there was more evidence of a submission being in process or being completed.
Some of the new regulatory pathways may lead to some changes to the steps of the BLA review process by engaged RA's as we know mfg readiness has climbed some in approval importance and it may be at least in shorter review timelines that labeling discussions come up sooner as well. Things are lining up for sure and it would be wonderful to find out the BLA submission has occurred, I am not as sure yet, still trying to confirm but I think getting closer.
GLTA
News 
Market Data 
Discover 
AI
