Posted by hok on June 30, 2004, at 9:28:46
In reply to Re: Selegeline GEL!! Comparable to selegeline patch???, posted by jeopardy on June 23, 2004, at 18:35:07
> I don't remember the woman I spoke with at Watson Pharm. You can call their PR dept. Her name and number is listed on their web-site. I do believe her answer was very conservative. Somerset Pharm took my phone number and said they'll call with updates.
I just called their Investor Relations dept as well. The guy I spoke with said that they will be re-submitting data to the FDA justifying the lack of need for dietary restrictions on the labelling. They should hopefully be getting that to the FDA by the end of the summer. Additionally, Somerset is still in talks with a marketing partner. Consequently, he said that it won't probably be launched until the end of 2004/early 2005.
Hopefully we can count on a shorter turnaround from the FDA for once, but I don't think we should count on it.
poster:hok
thread:358436
URL: http://www.dr-bob.org/babble/20040627/msgs/361945.html