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: Henry Niman who wrote (17962)	3/27/1998 1:44:00 AM
From: Peter Singleton	Read Replies (1) \| Respond to of 32384

Henry, I'm kind of underwhelmed by the announcement. While the final data is confirming the earlier data from the International trial, it's not real new news. The only surprise in the announcement is the delayed NDA. You've speculated that the delay was suggested by the FDA, in return for expedited review. Unless you have information that supports that, that sounds a little far-fetched to me. First, why on earth would LGND attempt to file without complete information from the trial? It seems clear that they needed to analyze the data (which they've just done), then massage it into the form required for an NDA. It sounds more to me like a poor estimate, and poor expectation setting, than a deal with the FDA. Second, why given the nature of KS, and the lack of satisfactory therapies, wouldn't the FDA give it expedited review anyway? Why would they bargain that for more complete data? Doesn't sound like the FDA in any respect. I don't think this is all a big deal. However, LGND set expectations that the NDA would be Q1 (hey, this is drug development, things slip sometimes, I know) when it seems apparent that they should have known for several months there was no way they would get the data together to complete the filing until sometime in Q2. These guys have pert charts and gantt (sp?) charts and project timelines and milestones coming out of their ears ... this type of thing doesn't come as a surprise. Peter