Cap raise likely. Approval, very unlikely.
It’ll take no less than six months to convince the FDA the potency issues are being addressed. Then, assuming MSB can do that, further trials. Then, further work submitting a further FDA application, and for the FDA to consider it again and make a decision.
18 months at best, but probably more realistic to think 24 months. No approvals anytime soon.
That’s reflected in the all time low SP.
Ann: Remestemcel-L Improves Survival in High-Risk Acute GvHD, page-88
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