Look up Pluristem and many others - they got IND approval after first Q&A .Applied for it last nov and got approval in feb. IT shouldn't take this long . Its heading into Q&A Round 3 very soon (if it hasn't already) .. The delay with FDA isn't because this stem cell science is so NEW that the FDA is having probblems screening and figuring out the SCIENCE as one person keeps stating...Its because the science that is being proposed is terribly incomplete hence acquiring other companys DATA ,as KOOS states "Dovetail" with HEMA data...What im trying to say is that if HEMA/BMSN data was so solid, they would have nailed it in the first Q&A...FDA IND data shows that at/with Q&A Round 3 ,approval drops considerably to below 50% (do the research)...Just Sayin !
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