You have made your position clear in the multiple times you have made fun of others that have brought this up. I don't find your post to be sincere. This is 1 day after:
"Moving forward I am going to attempt to be more positive."
That would be the best revenge that the AF cabal can be treated with. Love it if it happens. UK approval is a done deal I think. FDA can really surprise us with Dr. Pazdur's blessings if we had won it already.
Not me, I think the next step they may talk about is the preparation of the BLA and what a challeng that is and how once that ginormous step is complete and accepted then a 6 to 9 month fda review period. I expect approval sometime in 2023. I don't buy in to the tote bag theory but hope they have new ones for asco
Unfortunately it won’t happen this year. They have thousands of other things they focus on and we are just a tiny drop in the bucket for them, unfortunately. But that’s not to say we won’t be approved by FDA in 2023. We are pretty much de-risked from a data and regulatory approval point of view in my mind. Only a question of time.
I personally don’t believe we will have UK marketing and reimbursements approved this year either. Perhaps we get MHRA approval this year if we are lucky but that’s as far as I’d go. Again, these things take time so there’s nothing NWBO can do….as long as their applications are submitted in a timely fashion!