The last time we checked in with Austin-based XBiotech $XBIT, the company was trying to explain how it had screwed up a Phase III study of its lead drug Xilonix, confusing data on about 25% of its patients.
Over the weekend the company put out a batch of that data, and included this interesting note:
“Among responders (in both treatment and placebo arms), clinical response was associated with a 2.7-fold increase in overall survival (11.5 versus 4.2 months in responders vs. non-responders, respectively). Overall survival was not compared between treatment arms because after 8 weeks, all patients were eligible to receive study drug.”
Generally, when you can’t determine an OS rate or start counting placebo responses, you may cause more than a few chuckles in R&D circles. Adam Feuerstein at TheStreet was not amused. His review: “Absurd.”
Its stock was down about 46% this morning, but the market cap sits at an incredible $546 million.
$XBIT fiasco is equally embarrassing for ESMO. Why were these flawed data cleared for presentation at the GI conference this weekend?
— Adam Feuerstein (@adamfeuerstein) July 5, 2016
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