NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

My Speculative New Years Theory

Why all the recent delays and silence from NWBO the past 2 months?

I believe that top line data was so good that NWBO has requested accelerated approval for DCVAX.

Accelerated Approval (AA) is the only expedited program that provides a different route to marketing approval. AA approvals meet FDA standards for safety and efficacy. AA allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit.

https://www.fda.gov/news-events/fda-voices/delivering-promising-new-medicines-without-sacrificing-safety-and-efficacy#:~:text=Accelerated%20Approval%20(AA)%20is%20the,likely%20to%20predict%20clinical%20benefit.

How long will that take?

sixty days
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track#:~:text=Fast%20Track%20designation%20must%20be,need%20in%20a%20serious%20condition.

. . . So would expect to hear back by December 15th at the earliest.
If we give them a month to submit the application then January 15th.
. . . So TLD, Journal Paper and AA on around January 15th IMHO.