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.

Artery
Ehlers-Danlos is a group of connective tissue disorders that can affect many parts of the body, including blood vessels. • Source: Shutterstock

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