Replies to post #773344 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

yes you could be right here. I need some time to think about this and the 2 weeks comments delay (sucks big time)

[meirluc]

OTOH Mani, before this extension many BP's probably already sent their
comments to the MHRA and I have no reason to believe that those lagging
behind have procrastinated because they have more objections than the early
birds who already sent their comments to the MHRA. Most likely the MHRA
simply underestimated the time it will take to receive a sufficient feedback
volume.

A two week delay is annoying but hey, remember, this is the MHRA.

[dennisdave]

The MHRA stated:

“Following the consultation, the MHRA will amend and publish the guideline document, as well as publishing an anonymised summary of the public feedback.”

So the guideline will be published — I don’t believe Big Pharma will be able to stop that. I also think the MHRA is already processing incoming comments as they’re submitted, which means the final guideline should be released soon after the July 14 deadline, in my view.

The MHRA also said:

“Many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”

Translation: even if your external control arm is built from RCT data (as is the case with DCVax-L), the same regulatory logic still applies. The MHRA is explicitly not limiting its guidance to strict real-world data or individual patient data (IPD) formats. That point is now officially acknowledged, and no bad-faith actors can undo it. This strongly supports the structure used in the DCVax-L submission.

So yes based on this guideline and its direction, I remain optimistic about approval in July /august.