CEO Itescu needs to go, page-140

Hi @nippy

" Surely the biostatisticians realise that an AA is conditional on the stats holding up over time and ... "

Honestly, I suspect they aren't required to exercise their imaginations that far. Re the availability of Accelerated Approval, different contributors to the review committee would have had the responsibility of considering any submissions on the conditions of approval. We don't know that detail.

But your point is a good one, of course. If the source of the problem was something as mundane as a failure of imagination on the part of, say, the review biostatisticians or any review committee member, IMO it paints the very politically active Dr Marks in a very poor light i.e. that, despite his conflicting duties & the outrageous precedent he was creating, he could find reason to jump in & personally overrule his review committee on Sarepta's product, but not MSB's.

Cheers