The premarket clinical data requirements for CE are much lighter than what’s needed for FDA or with a drug, which means greater clinical uncertainty at this stage. So no I don’t agree things have been put to rest. Not sure if Notified Body evaluations are ever made public so we may never know if members of BSI committee had remaining concerns and what they want company to commit to with PMCF.
what I’m saying is that I don’t find it probable that if 50% (21/42) had already died at May/June last year as stated in their ASCO poster, that it can still be 21/42 dead almost a year later. It’s something that can easily be checked I’m sure so if I’m wrong that’s fine.
The premarket clinical data requirements for CE are much lighter...
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