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

To: Hippieslayer who wrote (11985)	12/2/1997 4:15:00 PM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

FUGAZI, Although I don't know why Poland was chosen, its pretty easy to understand why Europe and Australia were picked. LGND has already been involved in these areas when AGN did the International Panretin topical trial. In Europe, its frequently easier to go through the reveiew process and they now have a Tragretin track record. The began the Targretin diabetes trials in Europe because they accepted the Phase I safety data generated on cancer patients in the US. Thus LGND was able to begin the diabetes trials at Phase II (I think that the US wanted them to start diabetes at Phase I). Now they have Phase II data in Europe, so its probably easy to begin at Phase III for CTCL. The Panretin topical trial included an interim look and the trial was halted early. The halt saved money and gave them an additional trial to present to the FDA (originally they were just going to use the US data because the full International data wouldn't come out until after the NDA filing). I suspect that they are thinking about a re-run. The Phase I/II Tragretin oral and topical data on CTCL is quite compelling, so they can probably come up with another trial halt. Thus, the Interantional data may be ready for the NDA next year if it gets halted early, which is a very real possibility.