Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Lel H who wrote (27731)	1/30/1999 7:59:00 PM
From: Skeeter Bug	Read Replies (1) \| Respond to of 32384

lel, yes. i'm playing chicken with my lgndw. i expect to sell at least 50% of my holdings when 1 approval is announced and 2. lgnd starts to head down. i hope to get another couple points in the hype...

To: Lel H who wrote (27731)	1/31/1999 10:15:00 AM
From: Henry Niman	Respond to of 32384

Lel, Your question is a good one, and I suspect that we will have a definitive answer fairly soon. Although approval is widely expected, the key issue is more when than if (comments on this board not withstanding). LGND is on the verge of a couple of major related milestones in its development. One is FDA approval of its first in-house drug, and the second is profitability. This year's profitability is fairly dependent on Panretin and ONTAK approval soon. LGND already has its US sales force in place, and its really time to get the salespersons selling, so a long delay would definitely put profitability for this year in jeopardy. The latest rumor is for approval this week, so if approval is granted, it would be clear that one milestone has been achieved and the related milestone (profitability) was a distinct possibility.

To: Lel H who wrote (27731)	1/31/1999 10:39:00 AM
From: Henry Niman	Respond to of 32384

The other aspect of your question centers on IF the drugs will be approved. It's hard to imagine the FDA turning down ONTAK after their advisory committee voted 14-0 for approval, or Pantein being turned down after an 8-1 vote for approval, but this thread already has a post this morning indicating that "there may be a problem with the drug": Message 7579626 I've been posting on Ligand since 1992, and the lack of knowledge about the FDA has never ceased to amaze me. Of course just about anything is POSSIBLE, but there is public information that allows investors to better determine what is and is not likely. Most recent timetable projections have centered on a Panretin approval, which I suspect will come first (but both approval may come very close together). For Panretin, Ligand received an "approvable" letter, which is as close to a final approval as possible, without the actual final approval. LGND had indicated in their press release and conference call that there were two outstanding issues for Panretin approval. One centered on data for an expiration date, and the data had already been submitted, but had not been reviewed by the 6 month deadline defined by Panretin's "priority review" status. The second had to do with the wording of the label. LGND had wanted Panretin approved as a first line treatment, and the review board recommended the drug as a second line treatment. I believe that LGND has discussed this issue with the FDA, and rumor has it that the label will be silent on this issue. Since LGND received its official "approvable" letter shortly before the holiday season in Dec, and they want to "negotiate" the label, a final decision in Jan followed by formal approval in Feb would not be that unexpected. I certainly would not consider the above to be a "problem with the drug", but of course "problem" is not defined, so its hard to tell. Some seem to have problems with definitions, and the above comment reminds me of Phase III data from AMLN in Aug, 1997. AMLN failed to achieve statistical significance for their Pramlintide treatment of type II diabetes. To try to put a positive spin on this unfortunate result, AMLN indicated that the results were "clinically meaningful". Some actually thought that the press release was good news (and AMLN's price would rise from its previous close at about $15) and they couldn't seem to understand that the failure to achieve a statistically significant result in a Phase III trail was bad, and would lead to delays: Message 1988458 It's hard to believe that some expressing such a basic misunderstanding of drug approvals would invest or comment or biotechs, but obviously that is not the case (at least on the comment side).