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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Mudcat who wrote (29590)12/13/1999 3:22:00 PM
From: celeryroot.com  Read Replies (1) | Respond to of 32384
 
not sure if that for early or late
also , it is my understanding that near a 100% of patients become late stage



To: Mudcat who wrote (29590)12/13/1999 3:54:00 PM
From: Scott  Read Replies (1) | Respond to of 32384
 
What the panel recommended that the FDA ask for is a Phase IV study, which is not at all uncommon. All it means is that the FDA wants to see how this drug stacks up in a "face-to-face" comparison with a currently available drug. Once the FDA finds a drug "safe and effective", as the panel has recommended that they do, they are not going to pull it from the market on the basis of Ph. IV study results showing it is not quite as good as another treatment, just if it has bad sideeffects, etc. SUch a comparison study is almost never done in a Ph. II or III study, and is useful for the medical community and the FDA to have results on. Nothing at all for investors to be unhappy about. Particularly since there are so few alternative treatments available for this disease in late stages. I am curious what the panel recommended that Tangretin be compared against.