Replies to post #782187 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

thank you baxter

Your MHRA reply is one of the best, greatest news I have read in a long time here

[dennisdave]

Given your MHRA FOI reply I’m now convinced the MHRA is not waiting for the new ECA guideline to be formally published before deciding on DCVax-L. Your FOI response makes it clear: approval can be granted on scientific merit alone, without a finalized guideline in place.

That said, it’s still plausible they are reviewing the consultation feedback to make sure no serious objections were raised that could undermine their position. NWBO highlighted in the last 10-Q that they worked with doctors, patients, academics, and politicians to shape the submissions, which suggests they see this process as directly relevant to their case.

In practical terms, that means the decision doesn’t hinge on the official publication date of the guideline. Instead, timing depends on how quickly MHRA digests the feedback and feels comfortable moving forward. That could still stretch the review by weeks or a few months, lets say this autumn.

[manibiotech]

Thanks Baxers 

[Mr.reveulto]

Does that mean we’ll get the decision soon?

[Doc logic]

Baxers,

Thanks for the effort to clear up this investor concern. While not necesssry for a MHRA decision, waiting for all objections to be voiced certainly is politically prudent as dennisdave would suggest. Best wishes.

[Slave1]

Tommy, this is really valuable. The MHRA reply draws a bright line that often gets blurred:


1. External controls from RCTs are acceptable, even though they’re not “real world data.” The draft principles still apply, but nothing bars their use if comparability is sound.


2. Approvals do not wait on guidance. MHRA can already act under existing law if the evidence shows a positive benefit–risk balance. Guidelines are there to shape expectations, not to unlock the door.


Here’s the step beyond: this effectively confirms that sponsors like NWBO are not waiting on a bureaucratic calendar. The scientific case is the calendar. If the data package is strong enough, approval can move now. That means the regulatory bottleneck is no longer “process” but “persuasion.” In other words, MHRA has told us the pathway is already live, the only variable left is whether the submission proves its case.

And in the case of DCVax, the evidence is not just sufficient, it is overwhelmingly convincing.

[ATLnsider]

Thanks Baxers‼️It’s good to see definitively that all of the regulators, including MHRA & FDA are aligned on the fact that NWBio did not use RWD in its DCVax-L Phase III trial. As you may remember, I got a similar response directly from the FDA.

NWBio used pooled data from other contemporaneous randomized controlled trials (RCTs) to develop its ECA.

This type of ECA is allowed by all of the regulators, but it is not considered RWD.

Also, it’s good to know that NWBio has years of individual patient-level real world data (RWD) from its own Compassionate Use / Specials program, where they have treated hundreds of solid tumor cancer patients in the U.S., UK, Canada and the EU.

This RWD that NWBio directly owns could be used to help support the expansion of the DCVax-L approved label from beyond only newly diagnosed and recurrent glioblastoma (GBM), to include all or most other solid tumor cancers.