Why would the FDA approve fast track for a 3rd line treatment of a non-life threatening indication?
From the perspective of a regulatory organisation, surely the risk of shortened trials/ less data, huge potential user base etc far outweighs the benefits of earlier mass usage of what is currently only a pain reduction drug. Definitely apply for it if 08 gives Zilosul a DMOAD designation. Otherwise I honestly can't even see an argument that would be agreeable to the FDA for fast tracking this.
research reports and media, page-2225
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