Just needs to be likely that approval will happen. The Fraunhofer 2015 annual report already made approval likely BUT no one knew how much time it would take to meet all the requisites for a viable business model and sufficient patient access. Anyone trying to separate these two has an agenda or just doesn’t “get it”; ). Kind of important to keep one’s mouth shut while getting manufacturing and supply chain up to speed for the business model which includes an expected adequate reimbursement rate; ). Best wishes.
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