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Biotech / Medical : Ligand (LGND) Breakout!
LGND 195.83-0.7%Dec 26 9:30 AM EST
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To: Torben Noerup Nielsen who wrote (22435)6/17/1998 10:57:00 PM
From: Henry Niman  Read Replies (1) of 32384
 
Torben, I just saw the news releases tonight and haven't had a chance to figure out the significance (and additional information is probably required). However I think that I know what TD was referring to. He can answer himself, but one of my concerns was that SRGN would blow the FDA review because of lack of experience or expertise. I haven't followed the company that closely, but the limited impression that I had was that the company wasn't well managed. In spite of having a viable technology, the company's market cap was tiny and its problems were huge. Thus they became a penny stock.

My take on the press release is that the problems are more administrative than scientific or clinical. I could see it being something serious like the manufacturing plant not meeting FDA standards resulting in production of a questionable product, to something fairly trivial like labeling alterations.

I think that more data is required for such a determination to be made.

Bloomberg has LGND listed among its "market movers" for tomorrow, but I'm not sure how the street will react. The drug clearly works and will be approved sooner of later, although the press release doesn't do much for predicting a time line. The street ignored the SRGN acquisition as well as the FDA approval, so it may not do much about the latest developments.

The letter itself really sounds like a mechanism for the FDA to avoid the 6 month deadline, and the press release doesn't give enough info to determine the significance of the delay (if its days, weeks, or months).
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