Thursday, September 23, 2021 12:17:51 PM
There and still not been a case where the UK approval for a novel oncology came the EU (or FDA in case of ORBIS) approval. All they have done is piggyback on those two agencies
The first drug in the UK super duper innovative passport program was approved by the FDA a month ago. Still have not seen a CHMP recommendation. NICE has it on the calendar for next summer.
A few others in that program have been announced. We shall see, but I see little reason to believe that the UK will go from one of the slowest to one of the fastest.
They could have sped up the NICE process before Brexit, but they did not.
BTW, DCVax-L was never was approved under EAMS. They got the easy part, but still needed clinical evidence that it really works.
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