Immunex Message Board - Msg: 2819193

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Biotech / Medical : Immunex

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To: TideGlider who wrote (154)	11/25/1997 11:00:00 PM
From: Charles Hill	Read Replies (2) of 656

The source of the Montgomery downgrade has now been revealed....a couple of letters to the editor of the Nov 20th edition of the New England Journal of Medicine raise some technical questions about the efficacy of the Phase II clinical trials on Enbrel (that's right, phase II results, not the recently released phase III results). The authors of the study also repond to these criticisms. You can get the full scoop at www.nejm.org. The first letter questions whether the phase II study was really "blind" given that some injection site infections developed in patients recieving Enbrel who, therefore, must have been able to figure out before the trial finished that they were getting the drug (as must have their doctors).This is a somewhat convoluted and misleading criticism (it's of a Catch 22 nature), and is quickly dismissed by the authors of the phase II trials. Nevertheless, it seems to form the basis of the Montgomery analyst's assertion that the trials were incorrectly designed. One should note that Immunex's trials were designed in consulation with the FDA, so I doubt that this criticism will go far.

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