The SI DMX thread died 3 years ago. Although more posts to weed through, the Stockhouse thread recently allowed 200 ignores, so most of the daytrading rabble can be eliminated.
stockhouse.ca
All that is needed to force the user into cessation of use of Pennsaid is development of a rash at the site of application (it's in the instructions). Your leg doesn't have to fall off, or stomach cramps, kidney or liver disease or some other SAE,...all you need to kill use of Pennsaid is development of a rash.
And depending on the study, rashes have developed in 10% to greater than 30% of subjects,...and those were short term studies.
What will happen to a patient using Pennsaid 4 times per day, 365 days per year is what is in question,...and what both the FDA and Health Canada are concerned about.
This discussion has been going on for 4 years now, and all that is necessary for the group of cultist here to go goo goo ga ga and slobber all over the floor is for Kaynie to pump out one of his BS posts.
The timeline given by current management is eventual marketing in U.S. to take place no earlier than late 2007 to early 2008,...if everything goes well. If a bunch of rashes develop on chronic useage it could cause a reformulation and new NDA to the FDA. Then you might be looking at 2010 + for the U.S. and HC will likely restrict usage even more.
Old people skin is not like young people. It is slow to recover from injury, and quick to show injury after a little irritation. Chronic use of Pennsaid with older people has a high probability to reveal higher degrees of rash development over the short and long term. |
