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

To: jayhawk969 who wrote (26643)	11/21/1998 1:44:00 PM
From: celeryroot.com	Respond to of 32384

JD The FDA response on Pant. is due by Nov27. Ligand didnt have a due date on O. They are awaiting a letter from FDA.

To: jayhawk969 who wrote (26643)	11/21/1998 3:06:00 PM
From: Cheryl Galt	Read Replies (2) \| Respond to of 32384

> What was the risk from Seragen's view point? Was the date of manufacture explicit? Or does the mention refer to an accounting item? < No. The date of the Octak manufacture is not explicit. The 10Q for the 3rd quarter states an action and its risk: In preparation for the approval by the FDA, if received, Seragen has manufactured commercial quantities of ONTAK(TM) and in purchase accounting for the Merger the Company has capitalized approximately $1.5 million of work-in-process inventory as of September 30, 1998. 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. Since Seragen received the BLA letter that mentioned "deficiencies" in the second quarter (on June 2nd or 3rd), and since the 10K for 2Q says nothing about any capitalized Ontak inventory, I inferred from the 3Q 10K that Seragen must have started manufacturing Ontak after seeing the BLA letter. They surely would not have presumed to start commercial manufacturing before the committee's June 2nd decision. (I hope.) The wording in the 3Q 10Q sounds to me like a calculated risk they were comfortable taking during 3Q, even after seeing the "deficiencies" comments in the June 2nd letter from FDA. Did I jump to an unfounded conclusion? Am I grabbing at straws? As Celery says, we're waiting for FDA's response to this, with no date limit. (It's Panretin that has the Nov 25 response limit.) I wish this 5-month-simmering watchpot would boil. Back to our vigil ... Perhaps we should light a candle. ;-] Although, perhaps this is the type of drama we need to "surprise" the market with the eventual good news. Am I grabbing at multiple straws? Cheryl

To: jayhawk969 who wrote (26643)	11/21/1998 3:21:00 PM
From: Cheryl Galt	Respond to of 32384

J.D. Here's some news in the We-should-thank-our-lucky-stars Department. Look what the FDA did to Schering's Combisor, a psoriasis drug candidate. The anticipated launch of a new prescription topical medication for plaque psoriasis has been indefinitely delayed. The U.S. Food and Drug Administration (FDA) requested that Schering Corp. conduct additional safety tests in order for the product, a combination of a topical steroid and salicylic acid, to get FDA approval. Schering disagreed with the need for the tests, according to a spokeswoman, and the two side are at an impasse. This new product is "shelved indefinitely," she said, and may never be launched. This is from psoriasis.org Oct 1998 NPF - Psoriasis Research Online News July/August 1998 Research Roundup