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: Mudcat who wrote (27801)	2/3/1999 8:08:00 PM
From: Henry Niman	Respond to of 32384

I really don't think that the poster has a clue about how FDA approvals work. To speculate at the beginning of Feb that the lack of approval "may be due to a problem with the drug" was most highly unlikely. LGND's press release and conference call had already defined the outstanding issues, which would really be difficult to classify as a problem with the DRUG. One issue was providing the data to define the expiration date of the DRUG, and that data was submitted last year but the report by the reviewer was not finished in Nov, at the time of the 6 month deadline. The second issue had to do with the wording on the label. Neither issue would fall into a problem with the DRUG category. Problems with the drug would be discussed by the advisory board, and since they had voted 8-1 in favor of approval, there's not much left to fall into the DRUG PROBLEM area. The "speculation" on the "drug problem" had no basis in reality, and appeared to be designed to mislead the uninformed. It was very similar to an interpretation of a very clear press release that AMLN put out in Aug of 1997. The speculation AFTER the press release (that there was indication that approval would be delayed and clinically meaningful data was good) also had no basis in fact, and appeared to be designed to mislead. The "potential" of the reason was EXTREMELY close to ZERO, and the post was written to and by the uninformed (at best).