CEO Itescu needs to go, page-163

Hi @LeftYahoo

I wasn't suggesting " ...doing "studies" that rely on historical controls or some other shortcut rather than prospectively and randomly assigned controls...". That's not exactly what my post suggested that MSB is now doing, and you may have misread it.

Quite the contrary. What I am suggesting is that to me there's no apparent need for cohort randomisation if the new MSB study is prospective in all its elements, including selection of the control. Because then it will have unarguable FDA signatures on the bottom of the page before it even starts.

I don't see that there's anything wrong with external controls, or that they need to be historical, to provide acceptable RWE. I'm not aware of the FDA saying so either. Increasingly, they have a recognised place in FDA decision-making on marketing approval.

Re. the baseball analogy, I'd rather go with cricket - the captain's there till they find sandpaper in his pocket. In any case, I have to disagree with you regarding Novartis. In my opinion, Novartis paid MSB money to get in and look, but proved to be tyre-kickers, at best, and something less pleasant at worst. Either way, it wasn't the CEO's job to sell the company to Novartis regardless of the terms of the deal. And I'm leery of throwing any baby out with the bathwater.

I do however agree with you very much on management having a duty to communicate clearly. At the moment I'm after information. I'm no judge, and I don't have enough information to be a jury, so I certainly won't be acting as executioner of the CEO.

I will however be writing to him directly today, with my concerns and questions about what has happened, and what I see as an unarguable need for MS shareholders to be informed more fully (consistent with unavoidable confidentiality obligations) about the failure of the plan to obtain approval on the resubmission. I'll be copying the Chairman of the Board and the Secretary.

I'd encourage you and all other MSB holders to do the same if you share this concern.

Cheers