Posted by juanantoniod on September 4, 2003, at 14:28:28
In reply to Re: Any news on Cymbalta? » Juanantoniod, posted by River1924 on September 4, 2003, at 14:14:49
That's an interesting development. Thanks for keeping us posted, River.
Antonio
> The Wall Street Journal said that Eli Lilly and Co has been asked by the FDA for additional clinical trials in the last few days and will be approved "pending additional satisfactory data how duloxetine is metabolized." Clinical trials are time consuming. Immediately the company's share price fell.
>
> It is a bit confusing because duloxetine has been submitted to the FDA for two uses: depression and stress incontinence. The additional trials were requested for the stress incontinence application only. Since the the same chemical is used in both, "Lilly itself said it isn't certain [if the FDA requires more trials for both uses/applications] and has asked the FDA to clarify the issue."
poster:juanantoniod
thread:253499
URL: http://www.dr-bob.org/babble/20030902/msgs/256974.html