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


To: Russian Bear who wrote (22404)6/17/1998 6:28:00 PM
From: Flagrante Delictu  Read Replies (1) | Respond to of 32384
 
RB, If the letter was sent by regular mail instead of Fedex, anything is possible.



To: Russian Bear who wrote (22404)6/17/1998 6:40:00 PM
From: celeryroot.com  Respond to of 32384
 


Three questions were submitted to the committee for a vote. The committee first voted 14 to 0
that the clinical results cited in the Biologic License Application for ONTAK are "reasonably
likely to predict clinical benefit in patients with CTCL who have failed one or more systemic
therapies." The committee further voted 14 to 0 that the toxicity associated with ONTAK
treatment is "acceptable, given the response rates and durations of responses observed." By a
vote of 12 to 2, the panel also recommended that treating physicians should decide the
appropriate dose within a prescribed dose range.



To: Russian Bear who wrote (22404)6/17/1998 6:58:00 PM
From: WTDEC  Respond to of 32384
 
RB, I wonder if the letter might have been back dated at the FDA to comply with what I recall to be a 6 month reply requirement. Delayed release may not be SRGN fault.

Walter