GI Dynamics, Inc. Announces FDA Conditional Approval for Pivotal Clinical Trial of the EndoBarrier®

GI Dynamics, Inc. (Company or GI Dynamics) (GYDL) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to… GI Dynamics, Inc. (Company or GI Dynamics) (GYDL) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to commence a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese. The EndoBarrier is already approved and commercially available in select markets, including Chile, Australia and several countries in Europe. “We are very pleased that the Agency has chosen to recognize the substantial amount of scientifically sound data generated from our clinical trials conducted outside the United States, allowing us to move directly into a pivotal trial,” said Stuart A. See full press release