CEO Itescu needs to go, page-132

And who fills his shoes?

I would not say SI should not go, but you'd better have a very informed and capable candidate to fill his shoes.

Make some noises before the AGM people. Write to the Investor Relations demanding more information on the second CRL. If SI's strategy for the RCT (and it will have been at least run by the Directors by telephone) is at all at odds with the FDA's pre-requisites, in any respect, then yes he does need to go and so do some of the board ultimately responsible for business strategy.

Research trials are notoriously difficult. Its impossible to get everything right. Fauci was often a lone sane man amongst loonies during COVID, but he did the world a disfavour when he declared RCT's the gold standard. Even they are a tarnished bronze at best. One mis-judged or missed control and a trial can have entirely different outcomes. However, MSB misjudged the primary in CHF; same with a composite in CLBP; apparently didn't push the NIH on a rapidly changing COVID-19 standard for care and therefore changes to trial parameters; and finally proceeded a second time with ultimately a single-arm study against new non-trial control data.

Only MSB executive staff dealing with the FDA (and the Board on feedback) were best placed to judge this. They judged poorly evidently. The evidence was not even good enough to encourage the FDA to approve with a confirmatory RCT condition. Potency assay evidence was never going to do it alone and clearly the 4-year survival was not enough of a control context for the FDA's original reluctance to look at a single-arm study.

For all the clowns, that say "I told you so" with a tenuous grasp on the intricacies of this submission, this was in fact a weighted judgement call on a mass of complicated evidence, much of which very convincing, some clearly not convincing enough, given the context. Most suspected the FDA would always insist on an RCT and just thought it would be a confirmatory condition of approval.

SI needs to be more forthcoming on the particulars of the CRL.

And a final note to the know it all idiots who say I told you so, it was obvious. Rubbish. History says you were more likely wrong.

The statistics say a post-approval confirmatory RCT was clearly the most likely pre-post outcome. Go do some research, rather than wasting everyone's time on here with your senseless self pride.