Comments on: Forgetting The Rules? Wyeth, Elan & Alzheimer’s http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/ News, Comment and Conversation Fri, 10 Feb 2012 20:15:04 +0000 http://wordpress.org/?v=2.6.2 By: snugpharma http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/#comment-186621 snugpharma Sun, 02 Mar 2008 21:51:34 +0000 http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/#comment-186621 Excuse me, was it appropriate for On the Street's Adam Feurestein to use Peter Davies commentary without informing the public of Peter Davies pro Tau hypothesis and is recognised in Alzheimer's research as a staunch skeptic of the beta amyloid hypothesis. Great plug Adam, I don't think so. It's leaking already. snug The New York Times, 2007, Article on Alzheimer's disease; Peter Davies commentary http://www.nytimes.com/2007/12/26/health/26alzheimers.html?pagewanted=print Some scientists doubt the amyloid theory, but even a staunch skeptic said the studies were important. Among the skeptics is Dr. Peter Davies, a professor at Albert Einstein Medical College, who said: “You’ve got to try. Somebody’s going to get this right.” Excuse me, was it appropriate for On the Street’s Adam Feurestein to use Peter Davies commentary without informing the public of Peter Davies pro Tau hypothesis and is recognised in Alzheimer’s research as a staunch skeptic of the beta amyloid hypothesis. Great plug Adam, I don’t think so. It’s leaking already. snug

The New York Times, 2007, Article on Alzheimer’s disease; Peter Davies commentary

http://www.nytimes.com/2007/12/26/health/26alzheimers.html?pagewanted=print

Some scientists doubt the amyloid theory, but even a staunch skeptic said the studies were important.

Among the skeptics is Dr. Peter Davies, a professor at Albert Einstein Medical College, who said: “You’ve got to try. Somebody’s going to get this right.”

]]> By: ol cranky http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/#comment-184262 ol cranky Sat, 01 Mar 2008 02:53:45 +0000 http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/#comment-184262 I know a lot of people at Wyeth and they've had nothing but complaints about working with Elan on this project. Knowing how poorly done Elan studies are, I find this mildly amusing. CBER was notorious for not caring about the utility or validity of a tool used for primary efficacy. CDER is picky. It is possible that the companies made a good case for use of NTB in the SPA process and that the tool will be validated during phase III with those validation studies and all other supporting documentation being required to be submitted as part of the agreement with the FDA. It's also possible that the companies just pissed the agency off during the SPA process and the agency agreed to let them run the risk of hanging themselves so late in the game. I know a lot of people at Wyeth and they’ve had nothing but complaints about working with Elan on this project. Knowing how poorly done Elan studies are, I find this mildly amusing.

CBER was notorious for not caring about the utility or validity of a tool used for primary efficacy. CDER is picky. It is possible that the companies made a good case for use of NTB in the SPA process and that the tool will be validated during phase III with those validation studies and all other supporting documentation being required to be submitted as part of the agreement with the FDA. It’s also possible that the companies just pissed the agency off during the SPA process and the agency agreed to let them run the risk of hanging themselves so late in the game.

]]> By: adam feuerstein http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/#comment-184033 adam feuerstein Fri, 29 Feb 2008 22:50:00 +0000 http://www.pharmalot.com/2008/02/forgetting-the-rules-wyeth-elan-alzheimers/#comment-184033 ed -- thanks for the plug. great blog, by the way. adam ed — thanks for the plug. great blog, by the way.

adam

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