It’s the amount of approval needed to market the device in the UK, which would certainly not be true of the respective certification in the US.
MHRA approval related more to the reimbursement in this case. NVCR stopped pursuing it at some point.
Note that other forms of Optune are MHRA approved and reimbursed, though.
And if I were a shareholder of NWBO, the fact that there were issues with Optune’s phase 3 data would give me a lot of worry, because EF14 is about as strong a trial as DCVax’s phase 3 ended up being, doing a bad cross-trial comparison.
In fact, no one here has elaborated on why TTF is a bad treatment modality other than “I don’t trust the magic tinfoil hat.” In fact, the tech may complementary with DCVax for all you know
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