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

To: LLCF who wrote (26797)	12/7/1998 10:00:00 PM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

<<If I understand the situation here properly (having hung around about a couple weeks I may have it wrong) LGND's news is imminent... they either have to say they got approval or they got turned down for one or both products in short order right???? >> I think that you are close on the above, but not quite right. I think that the number of people who think that either ONTAK or Panretin would be turned down is very small. The advisory committee voted 14-0 to approve ONTAK and 8-1 to approve Panretin. In both cases, most are not asking if the drugs will be approved, but rather WHEN they will be approved. Both were granted priority review, which means that the FDA must say something within 6 months. In both cases LGND received a response on the last day of the six month period. For ONTAK they received a "completed review" letter, which meant that there were several outstanding issues. LGND addressed these issues some time ago, but since the FDA responded within the six month deadline, there is no ticking clock. On the 6 month deadline for Panretin, LGND received an "approvable" letter, which also stopped the clock, but the letter indicated that a smaller number of issues remained (expiration date of product and final product labeling). All of the analyst projections that I have seen for 1999 indicated that LGND would not lose money for the year. These projections were based in large part however, on Panretin and ONTAK sales for the entire year. If approval is delayed beyond this month, then it will be more difficult to show a 1999 profit. Thus, if there is no final approval by then end of this month, then the drugs will still probably be approved, but it will be harder for LGND to show a profit in 1999 because they will have less than 12 months worth of sales. Moreover, the bulk of the sales force has been hired, so LGND would continue to see an increase in expenses (the salary of the sales force), without off-setting income from drug sales.