Opko insists that ‘outliers’ screwed up its big PhIII study on a Pfizer-partnered therapy

Phillip Frost

Near the beginning of this year, Opko Health shares $OPK took a dive when the company reported out that its Phase III study of a long-acting growth hormone partnered with Pfizer had flopped. But it insisted that “outliers” in the study may have corrupted the results.

Today, Opko is insisting that these unidentified “outliers” are, in fact, the chief culprit for the fail. In a statement this morning, the company reported:

Analyses that excluded outliers showed a statistically significant difference between hGH-CTP and placebo on the change in trunk fat mass.  Additional analyses that did not exclude outliers showed mixed results.

Opko initially reported that the therapy didn’t do any better than a placebo. Anyway, investors weren’t quick to buy in. Its stock was down a bit in premarket trading.

Opko will have another chance to get it right, though. The company is doing a global Phase III for pediatric growth hormone deficiency. And there’s a pivotal pediatric GHD study going on in Japan.

“We are encouraged by the results of these analyses,” said CEO Phillip Frost in a prepared statement. But Opko also acknowledged that these post-hoc analyses don’t often carry much weight.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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