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


To: WTDEC who wrote (15631)2/22/1998 8:22:00 PM
From: Henry Niman  Read Replies (2) | Respond to of 32384
 
wtd, NDA applications are really out of my area, but they are not out of LGND's. Unlike most Biotechs, LGND drew almost exclusively from the big Pharmas for senior management (I think that the 1995 Annual Report indicated that senior management had brought over 40 multi-million dollar drugs to market).

Although this is LGND's first NDA, I'm sure that many who are working on it have done this before. I'm also sure that LGND is in close contact with the FDA to make certain that all goes well. LGND was 3 for 3 in the trials, including one halted early because the data was so strong. LGND has been preparing for this for some time now, so I expect it to go smoothly.

I recall reading on the LDAKA thread that they prepared an NDA in something like 6 months and thought that it was some sort of record. I really doubt it. LGND has been stating 2-3 months after final data was obtained, and everything that I have heard indicates that a filing this quarter is on track. The recent press releases on promotions and new hire may signal that the filing is sooner (this week) rather than later (next month).