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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: IRWIN JAMES FRANKEL who wrote (1873)	1/23/2002 5:57:48 PM
From: Cacaito	Read Replies (2) \| Respond to of 2515

The FDA was reviewing an open label Erbitux pII data (no placebo, no concurrent control, not blinded ) the lowest level of clinical efficacy trial available. This type of trial has a big potential for bias to eschew data (usually on the way of efficacy which is what researcher, clinicians, patients, investors and even regulators want). On top of that, there was not even appropriate documentation of data (x ray imaging proof of tumor changes, and/or the calculations), misaccounting of deaths (4 instead of 21?) and failure in controling for appropriate inclusion/exclusion criteria. The FDA rejected the "application", the data was not good even to be considered, it is the worst rejection a BLA could get. MD Anderson Institution (Houston): Medelsohn sold $6M of stock in October (as per the TSC). Not that He could not cash out on his long years of work, but everything is highly suspicious now that the FDA doubts of months(years) are out on the open. Erbitux was used alone in one pII (not presented yet, and apparently part of the data the company wants to present for BLA to be reconsidered) and the ongoing pIII could shed sufficient light to dispel doubt in efficacy. But, it is hope on a MAYBE, not the sure shot that was promised. And it will not be the first time that a big pharma blunders big evaluating a product. BMY just happens to pay a lot too.