It's been over a month since Forest Laboratories
The companies certainly wish the FDA would do something, but they're not sitting on their hands, waiting demurely. In true in-your-face fashion, Forest and Cypress released data from a third phase 3 trial, which confirmed the results of the two trials that the FDA is currently reviewing. Of course the companies were nice about it -- no need to piss off the FDA reviewers -- but I can only imagine that the executives were smiling as they issued the press release.
The companies didn't offer much data from the trial -- they're likely saving it for a scientific meeting. Hopefully the FDA won't need it, either; a request for the data could further delay the approval process, which is already nearly two months beyond the PDUFA date.
Forest and Cypress must be annoyed, but they've got company -- Eli Lilly's
I think we're likely to see an eventual approval. Hopefully this latest release of data reminds the FDA that it's got an application gathering dust. I'll join in the company's call: Approve the thing already.
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