Replies to post #737571 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

While it's possible that something negative can come up at any point of the review, I do agree that it's more of a positive thing rather than a negative one that we have not heard anything to this point. I do truly think the length is strictly due to administrative deficiencies and backlogs as well as the two indication application and extensive inspection schedule.

[dennisdave]

if the MHRA intended to deny the application, why would it take this long to reject it after receiving the RFI?

The MHRA could reject the request for approval at this point if they didn't like NWBO's feedback on the RFI and or based on what they encountered during the inspections. However, the suggestion made by Galzus Research that the MHRA could deny approval based on the DCVAXL SAP design (as a few other MD's have suggested) is highly unlikely for the simple reason that such discussion has already been had at the MHRA.

The MHRA is now at a point where they are reviewing if the inspection feedback and answers provided by NWBO on the RFI are in such a manner that it suits NWBO's claim of efficiency and safety of the DCVAXL trial. If thats the case then its unlikely the MHRA would change its mind on their view of the DCVAXL SAP. Also as we know the MHRA has bought into NWBO's pediatric GBM trial SAP which is the same as the one they're reviewing now.

So yeah a hit piece, although I agree with the lack of NWBO communicating.