Replies to post #780530 on NorthWest Biotherapeutics Inc (NWBO)

[Kam8]

🤞😆🤞

[exwannabe]

And again, that is 1-2 month after FINAL submission of a rolling review process.,

Per the FDA, and not an AI mash up:

To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application.

The CMC section, which foir a biologic is the most complicated, will be the last section NWBO has as they already have the rest.

So again, once NWBO is ready, they will presubmit the CMC (and whatever else they want) then 60 days later the final that starts the clock. So 4 months.

I am not sure if it is the math or the concept that is so difficult for you.

EDIT: Not that it matters. There is a reason NWBO has not applied. And it is not because they are waiting for a voucher they have no chance in hell of getting.