Replies to post #437402 on NorthWest Biotherapeutics Inc (NWBO)

[trocprofit]

It has certainly been inferred by DI in the past. He referenced the Lancet article as something to pay attention to. This would be the next validation of the FDA being more open to external controls. Perfect storm of positive TLD/Journal and FDA willingness to approve with external controls is on the horizon....just wish I knew how fast we get there.

[Bright Boy]

Newman, JED, Sukus and everyone,

Brighter days are ahead, so bright that I think we're all gonna need a new pair of shades!!!

Cheers,

BB

[exwannabe]

may be all the waiting or Quiet Period is all about FDA approval that I definitely won't be surprised.

I like that.

So NWBO submitted a BLA around Oct 2020. That would mean the FDA issued the CRL (thumb down) around June 2021 (even I would assume a priority review for a novel nGBM agent that asserts to improve OS).

Maybe it is COVID though and the FDA is just late. Yeah, that is it.