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.
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