The "patient-level data" discussion has gotten dumb. Of course we have the patient level data for the DCVax-L trial. Everyone knows that. And we have multiple quotes from LL confirming that they did not have that data for the ECTs. And critics of the trial say that that makes it apples to oranges.
LL would counter that the MAIC mitigates the problem enough to conclude clinical benefit and 73 experts in the field signed on to that. She would argue that perfect is the enemy of good enough especially when we are talking about an alternative to asking patients with a disease with no good approved options to be in a placebo arm, and would say, and has said, that patients need more options.
The above is all settled fact.
What is unclear and up for debate recently is what does the MHRA's new guidance on externally controlled trials have to do with this application, if anything.
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