Replies to post #691248 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Correct.

[dennisdave]

He says if MHRA had informed NWBO of any bad news then NWBO would have to disclose. As NWBO has disclosed no bad news, there was no bad news from the MHRA.

correct
I should have said it could mean they have not received an RFI yet. What I am saying is that Flippers reading between the lines assumes that NWBO requested an extension on the RFI so a second is incorrect.A second RFI would presume that the first is so complicated and complex that the first has to be extended. "The guidance states that requests to extend the clock off period for up to a further 60 days "may be granted only for exceptions"

The expected timeline is March 4 (the submission slot reset after the MHRA certified any clarifications + 150 + 60. That would be Oct., leaves will be turning colors.

Im afraid that you are right about this

The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

So 210 days from March 7 = September 23, 2024

(On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed.)

[dennisdave]

OTH the date Of January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation could be the date the application was validated. In that case, the approval will be confirmed on August 20, 2024.