We are still waiting for BLA submission. And the whole fast track approaqch hasn´t shown any results so far. I expect BLA submission not before mid January, very likely in February, perhaps even more delayed. FDA approval not in H1/2020 imo. I could imagine that NP sucked it in a way that approval is further delayed again (or not granted at all if the stories about BP influenicing FDA are true, then that is even more likely)

I wish so hard for moving forward, for progress. I have enough reasons to do so but I still feel like being in a very bad movie.


PS: My number of postings is limited, so when I stop answering, it is for a reason