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Further, the extraordinary affinity of HGF for Dihexa (Kd=2.2 x 10 "13 M) suggests that normally non- biologically active levels of HGF become physiologically relevant in the presence of a high affinity mimetic

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Summary In summary, we are finalizing a definition of bundled arrangement at 414.802 with the removal of the phrases of purchasing patterns and prior purchases and amending 414.804(a)(2) with new paragraphs (iii) and (iv) as proposed to provide guidance to manufacturers regarding pricing of bundled price concessions

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These studies have generally demonstrated positive therapeutic outcomes, but translation to clinical applications requires careful consideration of species differences and experimental limitations

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