FDA Advisors To Determine Need For Post-Marketing Study Of GTC Biotherapeutics’ ATryn
This article was originally published in The Pink Sheet Daily
Executive Summary
The antithrombin’s efficacy and safety profile suggest ATryn has a clear path to approval.
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FDA is acknowledging that clinical benefit for patients with rare conditions may best be verified through post-marketing trials, given the difficulty of conducting clinical trials in those populations
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Small payout now, but more may be due later, as the antithrombin goes up against sepsis and heparin resistance.