Doc Logic - I won't expand further than saying that the UK is completely broke. It's OT according to past moderation here. So I'll leave it there. Let's assume that's correct and the Regulator is cognizant of it. The Regulator knows once DCVAX-L is approved, then reimbursements will need to be available at scale for both nGBM and rGBM, which, without EDEN, would cost as much as $200,000. Either from the compassionate use program, or after submitting the MAA, data from other trials showing improved outcomes when DCVAX is used in combination with other modalities was made known to the MHRA. So from a budgetary standpoint does the Regulator approve DCVAX-L according to the specs trialed in phase 3 going with artisan first, and later transition to EDEN at lower cost? Or, would the regulator find that decision a bit hasty, knowing full well, that the approved modality is already outdated? If the Regulator has come to this understanding, that better outcomes require additional modes of treatment, then by default, it must wrestle with the cost becoming much greater than what DCVAX-L alone would cost.
What choice does that leave the Regulator? If the choice is to optimize positive outcomes, while looking to keep the financial burden under manageable budgetary constraints, then the Regulator would find EDEN to be a necessary, and welcome solution.
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