JP Morgan has published a research report on Endo Pharmaceuticals ENDP after the company received a complete response letter from the FDA regarding Opana ER.
In the report, JP Morgan writes "Endo received a complete response (CR) letter from FDA regarding its crush-resistant form of Opana ER, which suggests a modest delay for the product but importantly did not require additional clinical studies. Consistent with management comments, we anticipate Endo responds to the letter around midyear, potentially gaining approval by the end of 2011/early 2012. While
we had anticipated approval or a slight delay on the product, this complete response letter appears to involve slightly more time-consuming issues. That said, since additional clinical trials are not required and Endo plans to resubmit by midyear, we do not view this delay as a major setback for the Opana ER development program."
JP Morgan maintains its Overweight rating on Endo Pharmaceuticals, which closed Friday at $35.11.
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Posted In: Analyst ColorAnalyst Ratingsendo pharmaceuticalsHealth CareIndustrial MachineryIndustrialsJP MorganPharmaceuticals
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