Replies to post #21296 on Arena Pharmaceuticals, Inc. (ARNA)

[sts66]

Hadn't heard about the Swissmedic problem, as ARNA hid it in their 10-K, pisses me off too!

"With respect to Switzerland, Swissmedic provided feedback to our MAA in the form of a list of questions with major objections, which include objections that are similar to those identified with respect to our MAA for the European Union. We responded to the list of questions in writing, and we subsequently received a determination from Swissmedic that those concerns have not yet been satisfied and that our application would not be approved. While we expect to continue to work with Eisai to pursue regulatory approval in Switzerland, BELVIQ may not be approved for marketing in Switzerland when expected or ever."


Whether "not be approved" means formally rejected, or if ARNA withdrew the application, cannot be determined from that paragraph. Might be semantics to some, but it's not - rejection = start from scratch, unless the Swiss have something like a CRL, which if issued would be material info requiring an SEC 8-K. Sounds to me like ARNA pulled the app.