Posted by jrbecker on June 12, 2003, at 21:02:53
In reply to Re: Duloxetine/pregabalin/substance p antagonists, posted by pseudonym on June 11, 2003, at 1:27:42
As of reports dated june 11th, duloxetine is still on for fourth quarter. However, I read one financial report today from a top analyst that predicts it will be cleared for marketing prior to 4Q. When I have my appt with my pdoc in 2 weeks, I will ask if he knows whether there has been any new hints from his Lilly reps of a more finite date.
http://reuters.com/financeNewsArticle.jhtml?storyID=2912328&type=companyResultsNews
Lilly still expects 4th-qtr Cymbalta approval
Wed June 11, 2003 09:53 AM ET
NEW YORK, June 11 (Reuters) - Eli Lilly and Co. on Wednesday said it continues to expect U.S. approval of its experimental depression drug Cymbalta by the fourth quarter, following recent inspections by regulators of the plant where the drug is made.
Lilly LLY.N spokesman Rob Smith said the U.S. Food and Drug Administration inspected the Indianapolis plant on May 5, a necessary step before Cymbalta can be approved. Smith said Lilly may need to take additional steps to satisfy FDA quality-control requirements, but the company continues to expect U.S. approval of the drug by the fourth quarter.
poster:jrbecker
thread:232828
URL: http://www.dr-bob.org/babble/20030609/msgs/233557.html