Monday, September 17, 2018

showed statistical significance

OPKO conducted some post hoc analyses that showed statistical significance for the primary endpoint when those outliers are excluded and the company plans to meet with the FDA to discuss the path forward in adults, but my base case here is that it will need to conduct another phase 3 trial in adults. The phase 2 pediatric study was a success and I think hGH CTP is one of the potential market leaders. OPKO partnered hGH CTP with Pfizer and stands to collect royalties on net sales in the adult indication which should transition to a gross profit split of both hGH CTP and Genotropin if/when approved for the pediatric indication.

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