BioCentury

7:00 AM GMT, Jul 23, 2007
This article and the information contained in BioCentury's publications and services are solely for your own personal, non-transferable licensed use and cannot be shared with any other individuals. For information about adding subscribers to your account or obtaining article reprints, please contact support@biocentury.com.
Product Development

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

Read the full 1034 word article

This article and the information contained in BioCentury's publications and services are solely for your own personal, non-transferable licensed use and cannot be shared with any other individuals. For information about adding subscribers to your account or obtaining article reprints, please contact support@biocentury.com.