Replies to post #691357 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

That’s in Europe Ex, and NWBO did not modify their MAA. You are wronger than wrong.

Here is what Europe does

The Agency will ask the applicant via a request for Validation Supplementary Information (VSI) to submit the additional information, clarifications or corrections.
. The applicant provides the above additional information within the validation timeline. If the additional information submitted is as requested, the Agency will confirm the positive validation to the applicant.

That adds to the MAA Ex.

Whereas, NWBO states the MAA was never added to nor amended.

The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission. — NWBIO May 10, 2024 10q

[flipper44]

Ex, you are accusing NWBO of lying in its 10q.

Noted.

[dennisdave]

You really must be desperate to think MHRA is the same as EMA. And you are lying as well.
Yes the assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.
However, that date is January 24, 2024 and NOT as you falsy claim the date NWBO received news of the application has been validated March 7

Now the question is if NWBO has received an RFI. Yes or no. If they have received an RFI then they received it on April 13 2024 (80 days + Jan 24 2024)
In that case the date for approval news will be 210 days + Jan 24 2024= aug 20 2024. Most likely Scenario 1

From everything that NWBO and Les are communicating it seems that they have not and never will receive an RFI in that case the date for approval news will be
at Jan 24 2024 + 150 days = June 24 2024 Best case scenario 2

If the MHRA would still send an RFI today or this week, well than we are looking at fall 2024. Worse and most unlikely scenario 2.