To: IRWIN JAMES FRANKEL who wrote (2283 ) 12/12/2000 3:02:29 PM From: Biomaven Read Replies (1) | Respond to of 52153 Well MAXM cratered today, as it should have, given the damning FDA statistician's report available today on the FDA website. The Yahoo thread gives the url:fda.gov Some outfit called Washington Analysis was quick on the draw today (or they had early access to this report):MAXM spikes lower --12:16 pm - By Michael Baron Maxim Pharmaceuticals (MAXM: news, msgs) is plummeting $7.94, or 26.4 percent, to $21.75, on heavy volume of 1.53 million shares in midday action. The Food and Drug Administration's Oncology Drugs Advisory Committee is scheduled to review the new drug application for Maxamine, the company's lead drug for the treatment of metastatic melanoma, on Wednesday. Washington Analysis, an independent research firm, issued a note this morning saying it does not believe the committee will offer an approval recommendation. The firm cited documents posted on the FDA Web site that indicate the committee has serious doubts about Maxamine's approvability as a adjunctive therapy for the treatment of advanced melanoma that has metastasized to the liver. Among the committee's concerns, according to the Washington Analysis note, are that no stratification of prognostic factors was performed during clinical trials, efficiacy and tolerability of the treatment regimen hasn't been demonstrated in a pilot study, and safety issues, including a high death rate within 28 days of the last dose in the study. Officials from Maxim weren't immediately available for comment. Report author Ira Loss said Washington Analysis is a research boutique firm, whose clients include institutional investors and hedge fund managers, that specializes in analysis of the impact of government policy on financial markets. Score another for Avalon, who have always been skeptical of this one. I didn't want to play the ODAC lottery, and so I sold my very small holding some weeks back. Peter