IntelGenx Technologies Corp (IGXT)

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The CRL states that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study.

“Obviously, we are surprised and disappointed,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are committed to addressing the concerns raised by the FDA in the CRL. To that end, we will request a meeting with the Agency as soon as reasonably possible to discuss the scope of the CRL comments to obtain clarification and determine next steps.”