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Omeros Corporation Message Board

  • hilla2ro hilla2ro Apr 6, 2013 4:05 AM Flag

    Priority Review for OMS302

    OMS302 can receive Priority Review which means a faster approval process.

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    • Is the donkey #$%$ plugger still posting

    • ...HAW!!...not hardly:

      "The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment. Such advances can be demonstrated by, for example:

      ...evidence of increased effectiveness in treatment, prevention, or diagnosis of disease;
      ...elimination or substantial reduction of a treatment-limiting drug reaction;
      ...documented enhancement of patient willingness or ability to take the drug according to the required schedule and dose; or
      ...evidence of safety and effectiveness in a new subpopulation, such as children."

      ...but you see, OMS302 is NOT a "significant advance" fact, it's NOT an "advance" at all since ALREADY AVAILABLE drugs do EVERYTHING OMS302 does just as effectively and probably even more cheaply...

      ...besides, why the rush?...why do you think OMER's taking its sweet time about filing the NDA ?...hint -- they already know that no one's going to buy the stuff!...

      ...and judging by the stock price, pretty much everyone else seems to know it too!...HAW, HAW, HAW!!!...

      Sentiment: Strong Sell

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