Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles
A Regulatory Case-Study
Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker