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InterMune, Inc. Message Board

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  • musherga musherga Jan 17, 2011 11:52 PM Flag

    FDA knows FVC +4%=ITMN to OTC BB and BK!!!

    You're misinterpreting the data. Neither the controls nor the treatment group in the shionogi study improved in vital capacity.

    http://www.pmda.go.jp/english/service/pdf/Pirespa-Pirfenidone.pdf

    The placebo group showed a decline of 0.16L +-.02 (160 ml)
    while the high treatment showed a decline of .09L +-.02 (90 ml)

    Improvement here is being defined as less deterioration.

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    • <You're misinterpreting the data. Neither the controls nor the treatment group in the shionogi study improved in vital capacity...

      The placebo group showed a decline of 0.16L +-.02 (160 ml)
      while the high treatment showed a decline of .09L +-.02 (90 ml)>

      thnx for so very nicely illustrating the
      numbers that are being dallied about in the
      pr items.

      The 4% improvement in FVC is on the downslope
      of deteriorating lung function over time.

      And as the FDA says, those reported numbers
      are MEANINGLESS as compared to PLACEBO.

    • Did anybody else notice that there wasn't a dose-dependent response?

      The high dose group lost more vital capacity than the low dose group. -90ml vs -80ml

      This is suspicious since the maximum dose is barely above the therapeutic level.

 
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