Excellent news. Advances the timeframes directly, but also indirectly, because the increased access to FDA through the submissions and review processes gives clarity to those on the Paradigm side that they are drafting what FDA needs to see, and reduces the risk of further cycles of questions and clarifications, which is what smashed us last year.
Its a real boat-steadier. Just topped up.
Ann: FDA Grants Paradigm Fast Track Designation For OA, page-42
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