Friday, August 18, 2023 4:07:14 PM
I said maybe red tape or bureaucracy at MHRA is holding this up or combo data.
For instance, they may be getting some advice from their consultants (who are well in tune with the latest guidelines and recommendations from local regulatory bodies) suggesting to NWBO that they should wait for some more things to line up before they submit. And these could be some new guidelines that maybe forthcoming around ECA without patient level data, reimbursements, etc.
Or it could be that these consultants are advising them to wait until they can include ph 2 combo data to increase likelihood of success.
Otherwise, I don’t see a reason for them to not be in a position to apply to UK at least in April soon after MIA.
They are liars for sure. How do you justify UK approval comments from 3 years ago?
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