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Hyperion Therapeutics, Inc. (HPTX) Message Board

  • rrtzrealmd rrtzrealmd May 6, 2013 7:19 PM Flag

    Speaking of the prospectus...

    ...ol' illiterate "fields59" proably also missed this little tidbit:

    "The FDA allowed in the approved labeling only the data it felt was adequately established and not exploratory. The labeling focuses on the showing that Ravicti was non-inferior to BUPHENYL for the treatment of UCD based on measures of ammonia control.

    The FDA did not accept labeling regarding a pooled analysis of data from the clinical trials on Ravicti showing Ravicti’s superior ammonia control to BUPHENYL, Ravicti’s reduction of HA crises, or Ravicti’s improvement in executive function in UCD patients aged 6 through 17 years."

    ...in other words, as I have pointed out previously, HPTX can ONLY say ravicti is NON-INFERIOR to buphenyl and -- consequently -- WON'T be able charge more than the cost of buphenyl...

    ...or at least, third party reimbursers WON'T pay more for ravicti REGARDLESS of what HPTX tries to charge...

    ...tack that on to the already SHRINKING profit margins imposed by MANDATED discounts for medicaid and medicare accounts -- i.e. practically ALL of HPTX's customers -- and pretty soon, there won't be a thin DIME that HPTX will be able to squeeze out of ravicti!...

    ...HAW, HAW, HAW!!!...

    Sentiment: Strong Sell

 
HPTX
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