Ann: CE Marking Update, page-67

I'm many things but dim is not one of them.
Nonetheless, happy to "dim" this down for your benefit.

I have it on excellent aithority that in August 2014 BSI formally told Oncosil " ... the following issues/deficiencies need to be appropriately addressed by OncoSil in order to ultimately submit a positive recommendation to the BSI panel for approval of this product: ..."

Deficiencies were many and included that their trials to date were " ... sufficient to obtain some safety data ... " but " ... efficacy data is immature ... Ideally, randomised control trial data of both response and survival comparing standard of care chemoherapy vs that chemotherapy and OncoSil product should be sought and presented to more fully determine benefits vs. risks".

So yes, BSI did ask for a different trial. 4.5 years ago. When they made it crystal clear that the resulting data was absolutely required to enable the external clinical committee to recommend CE approval.

Who's misleading who?
Who's a dimwit?

The truth is still the truth, even if noone believes it. A lie is still a lie, even if everyone believes it.