Ann: Update on BLA for Graft Versus Host Disease, page-116

Tough medicine to take today.

First thoughts:

1. FDA are apprehensive about approving a new type of treatment so are ultra conservative. Which they can do if they want. It's their jurisdiction.
2. Hard for the kids as MSB will now need to decide whether their cash should be exclusively directed to the adult trial or to funding relief for kids who need it.
3. The company defined a path forward and controlled the controllable's as they saw fit. They believed approval for kids would then fund a trial for adults. Problem was; no approval.

So we are back where we were two years ago.

Which means:
1. Flight of investment out of MSB
2. Lower share price means more dilution when they need to recharge cash
3. Approval was meant to fund a lot of trial work, which means there will either be a need for money or a cutting of activities.
4. A white knight pharma may come in to take up a partnership however it will be under very poor terms for MSB, but most likely they will all hold back given they'd have no confidence in what the FDA will do next.

Overall, I'm sad. rather than angry. I think I'd got myself to the position now of assumed failure rather than success to avoid being too hopeful.

Hope everyone has not overextended themselves as that is a hard place to be.