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Poor Man -

01/03/22 8:43 AM

#431488 RE: dennisdave #431459

FDA no, but perhaps the UK.

My thinking is at least approval from one RA to trigger a BO.

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antihama

01/05/22 10:20 AM

#432174 RE: dennisdave #431459

Totally rational post and mostly concur w

Because even if we will see TLD + publication this month I do not see the BLA submitted until this fall, and I therefore do not see FDA approval between now and the beginning of 2023. I love for it to be different, but it would take a small miracle in velocity something NWBO has proven to be no good in.

Totally agree they did not submit a stealth BLA but I might quibble w the timeline of submitting the BLA in the Fall. I mean they just can't be standing still on putting it together over the last year from data lock...one would hope. If that is the case than I could see it being submitted a couple of months earlier since they would request a pre-BLA meeting normally around 6 months earlier w a BLA being submitted in late summer which is almost the same as what you said 'Fall'. So the whole point of my post is to concur w you that a BLA has not been submitted yet.