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
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