I believe its all about manufacturing now. That is the roadblock that fda has put up. And I thought fda would have and should have allowed small indication likre gvhd get approved so meso could work through manufacturing issues. And second approvoal of gvhd would have validated the platform allowing money to flow in and then bringing down the cost of manufacturing for the larger therapies like heart and back.
But that would be just common sense rght.
Anyway new guidance was supposed to come out 8 months ago that would bring new treatments like ours to maket quicker... we wait
Cell Therapy News/Articles, page-14510
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