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

To: rocket who wrote (15381)	2/19/1998 6:00:00 PM
From: Henry Niman	Respond to of 32384

Karl, I have been saying for some time that the FDA reform and LGND's clinicals are well timed. LGND generally publishes results within months after completing trials. Thus Phase I data is in the literature and Phase II data for larger indications should be published within a year, right about the time of FDA approval. Unfortuantely, cancer treatment still leaves much to be desired. Overall, mortality today isn't all that different than it was in the 50's (thanks in part to heavy cigarette usage). LGND's drugs should have applications for a wide range of malignancies (as well as metabolic diseases). The off label cancer applications should be significant. As far as I can tell, that is the major force behind the lid on LGND's stock price. Most, if not all analysts, expect LGND's stellar clinicals to continue with oral and topical Panretin and Targretin winning FDA approval this year or next. However, the current markets are on the small side. Once the compounds are approved however, they can be prescribed for any medical condition. Peer reviewed journal article will be distributed to physicians and off-label use will explode. MM thinks that the NDA for topical Panretin (this quarter) will drive the price to the high teens or low 20's. If the street pays attention, he will be correct (LGND at $18 is STILL cheap).

To: rocket who wrote (15381)	2/20/1998 3:46:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Karl, Here's a recent FDA press release (with a link to their timetable of implementing the 1997 FDA Modernization Act, which includes off-label use changes): Press Office Food and Drug Administration U.S. Department of Health and Human Services NOTE TO CORRESPONDENTS Print Media: 301-827-6242 February 10, 1998 Broadcast Media: 301-827-3434 Consumer Inquiries: 800-532-4440 FDA POSTS IMPLEMENTATION CHART FOR THE FDA MODERNIZATION ACT OF 1997 ON ITS WEBSITE FDA has posted on its Website (at URL fda.gov a comprehensive chart detailing the many tasks it is required to implement under the Food and Drug Administration Modernization Act of 1997 (Public Law No. 105-115). This law required FDA to undertake dozens of regulatory and program initiatives related to the regulation of drugs, foods, biologics, and medical devices. This Website chart lists tasks that are specifically required by the statute as well as those that the agency has deemed necessary to assure the effective implementation of this law. Each listing on the chart will highlight a particular initiative being taken to implement the law. This listing will be accompanied by information about the specific section of the statute that is being addressed, a description of the initiative, the deadline listed in the statute for that initiative (where applicable), and the name of the person at FDA who can be contacted regarding this initiative. In addition to this chart, FDA will make regular public announcements about the overall status of this effort as major initiatives are put in place and completed over the months to come.Press Office Food and Drug Administration U.S. Department of Health and Human Services NOTE TO CORRESPONDENTS Print Media: 301-827-6242 February 10, 1998 Broadcast Media: 301-827-3434 Consumer Inquiries: 800-532-4440 FDA POSTS IMPLEMENTATION CHART FOR THE FDA MODERNIZATION ACT OF 1997 ON ITS WEBSITE FDA has posted on its Website (at URL fda.gov a comprehensive chart detailing the many tasks it is required to implement under the Food and Drug Administration Modernization Act of 1997 (Public Law No. 105-115). This law required FDA to undertake dozens of regulatory and program initiatives related to the regulation of drugs, foods, biologics, and medical devices. This Website chart lists tasks that are specifically required by the statute as well as those that the agency has deemed necessary to assure the effective implementation of this law. Each listing on the chart will highlight a particular initiative being taken to implement the law. This listing will be accompanied by information about the specific section of the statute that is being addressed, a description of the initiative, the deadline listed in the statute for that initiative (where applicable), and the name of the person at FDA who can be contacted regarding this initiative. In addition to this chart, FDA will make regular public announcements about the overall status of this effort as major initiatives are put in place and completed over the months to come.