Arena Pharmaceuticals Receives FDA request For NDA Protocols (ARNA)
Interesting development in biopharm/tech land… ARNA is down quite a bit after hours on release of some not so hot FDA news..
“Arena has receives a request from the FDA to submit protocols for the lorcaserin New Drug Application, prior to initiating certain studies, and expects to provide Arena with its comments and recommendations within approximately one month of each protocol submission. In December 2010, Arena reported on its discussions with the FDA at the end-of-review meeting including Arena and Eisai’s plans to address the lorcaserin Complete Response Letter and the expectation to resubmit the NDA to the FDA by the end of 2011. Arena is continuing its discussions with the FDA to finalize protocols for activities that are designed to address the issues raised by the FDA or that otherwise are related to the assessment of the benefit-risk profile of lorcaserin. Arena continues to believe that it can resubmit the lorcaserin NDA by the end of 2011. “