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DepoMed Inc. Message Board

  • acricketeer acricketeer Feb 25, 2013 10:16 AM Flag

    DEPO Is Not AFFY

    Some investors are scared because of the the massive recall and stock carnage from AFFY following deaths of a recently approved drug for kidney dialysis patients. Adding to the nervousness is this morning's announcement of the CRL issued to DVAX for a Hep-C vaccine. While safety os a primary concern fr the FDA, this should not impact the Serada. First of all, Serada is almost identical to Gralise (with the exception of some excipients), which is already approved for a different indication. Second, the active ingredient in Serada/Gralise is gabapentin, a compound whose safety profile and mechanism of action are both well known. In fact, Gabapentin is practically a physiologic agent, as GABA is already made in the body and the encarbil form is simply designed for improved bioavailability and a tag to the gabaminergic receptor. Third, the safety profile for Serada is improved by its sustained release action. Efficacy is another matter and may lead to a negative vote, but that's a whole other discussion. Most analysts give little value to this NDA anyway, so I would expect the downside to be limited in the short term if the vote goes against DEPO. I would view the rejection by the FDA of the name Serada as neutral to positive,. IMHO, it hints that they're already planning a label post-approval.. DEPO's website also shows a position open for a Womens' Health Sales Specialist which doesn't fit with their currently approved formulary at this time.

19.02+0.02(+0.11%)Nov 25 4:00 PMEST