In short ( no pun intended ) That MC assumes 0 success of any other product, in any other indication. No off label No crohns label expansion No adult GvHd No CHF accelerated approval No CLBP
The crohns and adust Gvhd alone is several times the size and therefore several times the MC, and importantly is a label extension and not the circus we just went through for child GvHD This means - focus is on efficacy and not manufacturing release assays. Now the company have the only recipie for FDA approval for MSC therapies, the follow on appprovals are much easier.
Expected margin has been spoken about before in the area of 40% increasing to 60% with advances in manufacturing ....... However the pricing of gene therapy, and MSB's price has caught people off guard. The margin could be on the high side.
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