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


To: WTDEC who wrote (22394)6/17/1998 5:57:00 PM
From: Hippieslayer  Read Replies (1) | Respond to of 32384
 
I read the release a couple times and I can only guess that there are serious problems because there are many things the fda wants SRGN (now lgnd) to address. Anyone care to comment on this?

Lgnd might want to bring out the rats tomorrow to counter this PR.



To: WTDEC who wrote (22394)6/17/1998 6:12:00 PM
From: Flagrante Delictu  Read Replies (5) | Respond to of 32384
 
Walter, To quote from Bloomberg's report on the story, " The FDA's letter means the drug can't be approved until the deficiencies are corrected", the companies said. Still, officials of SRGN said the agency's action was not a significant setback for the drug.
"We don't view this as something that is unusual or daunting or larger than usual" said Jean Nichols, president & chief technology officer at SRGN.
" This is primarily clarification" of the company's studies, she said."It's not new data, not new trials."



To: WTDEC who wrote (22394)6/17/1998 6:12:00 PM
From: Russian Bear  Read Replies (3) | Respond to of 32384
 
Walter and all,

<<The BLA was submitted on December 9, 1997, and the complete review letter is dated June 9, 1998.>>

I am wondering (1) What could possibly have changed so dramatically within one week of the unanimous positive recommendation regarding ONTAK's safety and efficacy? and (2) Why was the patently material new information regarding the FDA delay not disclosed sooner?

My initial reaction is that there is something seriously wrong with Seragen, something which was likely not known to Ligand's management at the time that they inked the deal.

RB