Corcept's phase III study demonstrated Korlym's efficacy but safety issues and concerns -- low potassium levels, adrenal insufficiency, endometriosis in women and possible heart rhythm abnormalities -- will likely keep the drug from being approved on a first pass.
If you're curious, I'm not alone in predicting Korlym's rejection next week. Forty-seven percent of contestants in my 2012 FDA Drug Approval Contest agreed with my assessment compared to 42% who believe Korlym will be approved. The remaining 10% predict a delay in an FDA decision.
Oncothyreon (ONTY) bull @given2tweet challenges me (an Oncothyreon bear) to refute some facts/assertions that he believes points to a positive outcome for the ongoing phase III study of Stimuvax in non-small cell lung cancer. Merck KGaA, which licensed Stimuvax from Oncothyreon, is running the lung cancer trial. Results from a second interim analysis are expected this quarter.
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