Replies to post #85218 on Biotech Values

[jbog]

Dewophile,

You make some good points. I just don't like the unpredictabily of the FDA right now.

My initial feeling is that they would want the generics on the market as fast as possible, but I guess I was wrong.

[srsmgja]

The New FDA - Courtesy of the hugh Democratic majority and our new President.

The FDA is a politcal animal, and right now they all looking down the barrel of a loaded gun, with Uncle Henry Waxman, John Dingell, Pete Stark, and a host of other characters holding the trigger.

This new FDA is going to be extremely safety minded....

My favorite subject - FTY -720 and Cladribine will never get approved on the first go.... TOO MANY SAFETY ISSUES

The FDA will demand 2 completed 2-year safety phase 3 trials for both drugs. You can forget about 2010 approval........ these drugs will be lucky if they get apporval before early 2012 (FTY) and 2012-2013 (cladribine).