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Re: Baxers post# 782187

Monday, 08/18/2025 9:45:00 AM

Monday, August 18, 2025 9:45:00 AM

Post# of 821336
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.
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