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Biotech / Medical : Imclone systems (IMCL)
IMCL 0.1590.0%Oct 5 5:00 PM EST
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To: 613 who wrote (2114)2/27/2002 4:41:13 PM
From: Cacaito  Read Replies (1) of 2515
 
"33% of patietns lived beyond one year, compare to 18%" "SIMILAR" patient population.

This is a reference to a historical control, even if very well done is one of the most common source of false hopes and errors in drug evaluation.

A trial with double-blind, placebo-control, concurrent control subjects and prospective, better if multicenter IS the way to prove effectiveness with the highest validity.

The Erbitux trial is full with mistakes and missing data, the 33% vs 18% is not to be trusted. The company failed to report 19 out of 21 deaths during the reportable period (within one month of completion of trial), and now they are giving this % differences as proof of what? the only proven thing here is the company utmost inability to do a trial.

It is very easy to claim a lot against the Fda, and the "leak" of the RTF as the cause of the problems cause the FDA policy is NOT to comment about companies. And this is the way companies DEMAND.

The same company that is defended by WSJ cause "investors are not giving more information from FDA about the process" and are complaining about the leak of RTF, IS THE SAME that rosy up the status of the drug for months and downplayed the significance of the RTF itself, new trials are needed is still the reality, that they could use the ongoing trial from mercky germany does not change that reality.
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