Replies to post #690421 on NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Yes, Red Right Hand, no changes, so they did not get a letter of request for more info. Now the question is: Since validation was in late January, are they still on track to be approved May 24th, which is 150 days after the Dec. 25 deadline to submit application?????
Let's hope so. Sounds like the delay with validation was on MHRA side.

[marzan]

Very Good!

[learningcurve2020]

Disciples here fought me hard that none of this Acceptance (They call it validation) nonsense was necessary. Why the company failed to PR it is a head scratcher.

[beartrap12]

The MA track is different than we expected. Does anyone understand why they have listed two dates for validation??

MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.

As is typical, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company will announce the results when the regulatory review and decision - making about the MAA is complete.

So, obviously, no RFI letter or they would be talking about having to make, or having made, changes. First, they passed validation on January 24, then their validation was confirmed on March 7th.

It sounds like everything is "go" to me.Apporval sooner rather than later since our application has two differnet validations?? IMO

[RobotDroid]

Mmm..this makes me think sooner rather than later. May flowers?

[CaptainObvious]

This is big, IMO