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


To: Russian Bear who wrote (22399)6/17/1998 6:17:00 PM
From: jayhawk969  Respond to of 32384
 
RB,

"The letter identified certain deficiencies in the application related to safety, efficacy,
manufacturing and product characterization.

The key word to me is application, deficiencies in the application--not the product.



To: Russian Bear who wrote (22399)6/17/1998 6:18:00 PM
From: celeryroot.com  Respond to of 32384
 
I do not know what the situation is in this case but this is not unusual. It could be a labeling problem or numerous nits. If you look back over other advisery approvals you will see they usually have a few questions attached which need to be ironed out.
What I do think is that this is very poorly written and leaves a big question mark.



To: Russian Bear who wrote (22399)6/17/1998 6:18:00 PM
From: Flagrante Delictu  Read Replies (2) | Respond to of 32384
 
RB, I think we can assume that LGND reviewed the filing by SRGN & thought it was acceptable or it wouldn't have done the deal. Maybe, it is only bureaucratic nitpicking. We should get LGND's interpretation soon.