Insmed (INSM) falls 18% premarket after reporting the results of a Phase 3 trial for Arikace....

Insmed (INSM) falls 18% premarket after reporting the results of a Phase 3 trial for Arikace. Although the treatment achieved the primary non-inferiority endpoint, it appears Arikace did not show as well as tobramycin inhalation solution in terms of FEV1 (see presentation, slide 3).

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Comments (2)
  • GaryLee276
    , contributor
    Comments (151) | Send Message
    Durnit. I am glad I hesitated on this one.
    1 Jul 2013, 08:28 AM Reply Like
  • MWinMD
    , contributor
    Comments (3417) | Send Message
    Sigh. Statistical tests are there for a reason. Tobi was not even CLOSE to showing superiority. The p-value on the FEV comparison was .48 (not even a trend for Tobi being better). The test for difference in sputum density was a bit closer, with a p-value of .12 (nearly a "trend"). But that STILL doesn't confer superiority on Tobi, even though Tobi benefits from a one-sided test (per a comment in the conference call), which gives it twice the power for a given mean difference for the measured variability within the sample.


    I don't know whether to laugh or cry at the level of statistics education in our society. Everyone on Wall Street thinks Tobi was shown to be "better", but by statistical test, it wasn't. Not even close, FEV-wise.


    I expect to see some big insider buys over the next few days, once the sell off looks done. I will be tagging along. These guys are probably shaking their heads in disbelief right now. Oh well!
    1 Jul 2013, 08:09 PM Reply Like
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