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

To: jayhawk969 who wrote (26640)	11/20/1998 5:15:00 PM
From: celeryroot.com	Respond to of 32384

ok, it doesnt say concerns with manufacturing it says there were deficiencies in the application. We discussed this before when it happened. This is not uncommon. I was told by a Ligand spokes person that it had to do with labeling and administrtaive record keeping. I've seen this numerous times before with various compnies.

To: jayhawk969 who wrote (26640)	11/21/1998 1:10:00 AM
From: Cheryl Galt	Read Replies (1) \| Respond to of 32384

J.D., Thanks for posting the Seragen press release regarding the BLA, the missing piece in my jig-saw puzzle. FWIW, Here's my interpretation. The wording is so vague that interpretation seems impossible. What's an "application?" The wording on the application? or the substance defined by it? Who knows?? What eases my mind is the TIMING of events seen via these two documents. For me, "watching the bouncing ball" works better than trying to decipher lawyer-ese. --------------------- AFTER receiving this June 3 letter that "identified certain deficiencies in the application related to safety, efficacy, manufacturing ... " Seragen WENT AHEAD in the third quarter with a capital expenditure of "approximately $1.5 million" and "manufactured commercial quantities of ONTAK," fully KNOWING that "If the FDA does not approve the BLA, and ONTAK(TM) is not approved for commercial sale, any capitalized costs related to ONTAK(TM) will be expensed." --------------------- I can't imagine them taking such a risk if there was any substantial problem with the manufacturing process itself. (I hope I'm not naive here ... What do you think?) I'm relieved to know that Marathon has actually prepared a commercial batch of Ontac -- relieved enough that i have two limit orders pending for Monday. (Ligand spent plenty for Seragen. I needed this confirmation that Marathon could produce.) Cheers :-) Cheryl