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DepoMed Inc. Message Board

  • isaac_dji isaac_dji Jan 19, 2011 4:03 AM Flag

    ABT WAITED until JUST before APPROVAL because

    ABT did not bring up its contractual dispute with DEPO until JUST BEFORE APPROVAL.

    The reason for that is simple: Earlier during the NDA review, ABT was not certain about the FDA APPROVAL of DM-1796 and therefore, it did not bring up the contract dispute because there was a chance of a negative FDA decision, which would have nullified the contract.

    But NOW, since ABT is quite CERTAIN of FDA APPROVAL, it could no longer delay the contractual dispute.

    According to DEPO's CEO, DM-1796 received its ORPHAN DRUG STATUS because of its SIGNIFICANTLY SUPERIOR SAFETY PROFILE as compared to the current PHN drug (immediate release gabapentin). And these are the EXACT SAME ATTRIBUTES of DM-1796 that the FDA uses for APPROVAL.

    The fact that DM-1796 regimen is a single daily tablet (as opposed to multiple daily pills for IR gabapentin) is the ICING on the CAKE.

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