Neurochem sticking it out

When Neurochem Inc. began talks with FDA about the design of a pivotal trial for Kiacta eprodisate in amyloid A amyloidosis, the discussions centered on executing a single Phase II/III trial with a primary composite endpoint. At the time, a single trial gauging renal response seemed to be the best move forward, as AA amyloidosis has a small patient population, well-defined renal response criteria and no treatments that address the underlying disease.

Two FDA approvable letters later, the second of which was issued last week, Neurochem is counting on follow-up data from the Phase II/III trial and data from an open-label extension study to

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