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


To: J Stone who wrote (27711)1/29/1999 6:05:00 PM
From: Henry Niman  Respond to of 32384
 
I believe that Robinson's conference call right after the "approvable" letter indicated that there was one QC test missing (to define the expiration date of the product) as well as the final label issue. The unresolved issues were also detailed in LGND's press release:

"The final approval is pending review of additional chemistry information submitted by the Company as requested by the FDA and upon final labeling agreement."

I believe that both issues have been resolved and the label will be silent on second line usage and the announcement could be any day.