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killers_420

04/24/14 8:36 AM

#10442 RE: RobertJames #10441

Thoughts anyone? I am a little surprised by the additional CMC data needed. Also, the following statement leads me to believe approval is further out than early summer.

The Companies believe that FDA approval of the RHB-103 NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, RedHill and IntelGenx (IGXT) continue to work with the FDA in order to submit all the data requested and will provide an update as and when applicable.