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Re: manibiotech post# 805714

Wednesday, 12/31/2025 9:06:00 AM

Wednesday, December 31, 2025 9:06:00 AM

Post# of 819716

So looks like DCVax was discussed and CHM advised on it My understanding was that MHRA refers application to CHM if they are not comfortable approving without their advisement ?? Is that correct ?



Technically, yes.

MHRA is allowed to unilaterally approve a drug without referencing the CHM.

They are not allowed to unilaterally reject an application without referencing CHM.

That being said, in practice it isn’t as much of a sign of them being uncomfortable approving unilaterally as it is a matter of procedure for a drug like this. I don’t think this ever stood a chance of avoiding a CHM review, so it’s not a hard sign that MHRA was really considering a rejection.
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