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Tuesday, January 29, 2008 3:10:50 PM
Interesting message from the iv board: hope you like it.
Anyone out there who is not delusional and is interested in an apples-to-apples comparison of Alimta and Onconase, look at the report of Alimta as a single agent for treatment of mesothelioma in the Expanded Access Program that made Alimta available to meso patients even before it was approved for marketing: ASCO 2007 abstract #7709: Median Survival Time 14.1 months. Then have a look at ASCO 2000 abstract #2274 for the info on Onconase as a single agent from the first meso trial that FAILED: MST for the Intent To Treat group of patients was a pathetic 7.7 months. That Treatment Target Group hocus-pocus was the result of retrospective data-mining, and was not part of the trial's protocol. But it is central to the so-called IIIb. What it amounts to is cherry-picking of patients who are good candidates for extended survival going into the trial. It is an admission that Onconase does not work for a large segment of the general patient population. The Alimta trials did not employ that kind of hocus-pocus. See July 2003 editorial in the Journal of Clinical for their description of LLY's Alimta trial as a model for phase III trials. Then look for a similar editorial on any of of ACEL's three FAILED phase III trials, or on the current sloppy phase IIIb that has been going on, and on, and on, since the turn-of-the-century.
Anyone out there who is not delusional and is interested in an apples-to-apples comparison of Alimta and Onconase, look at the report of Alimta as a single agent for treatment of mesothelioma in the Expanded Access Program that made Alimta available to meso patients even before it was approved for marketing: ASCO 2007 abstract #7709: Median Survival Time 14.1 months. Then have a look at ASCO 2000 abstract #2274 for the info on Onconase as a single agent from the first meso trial that FAILED: MST for the Intent To Treat group of patients was a pathetic 7.7 months. That Treatment Target Group hocus-pocus was the result of retrospective data-mining, and was not part of the trial's protocol. But it is central to the so-called IIIb. What it amounts to is cherry-picking of patients who are good candidates for extended survival going into the trial. It is an admission that Onconase does not work for a large segment of the general patient population. The Alimta trials did not employ that kind of hocus-pocus. See July 2003 editorial in the Journal of Clinical for their description of LLY's Alimta trial as a model for phase III trials. Then look for a similar editorial on any of of ACEL's three FAILED phase III trials, or on the current sloppy phase IIIb that has been going on, and on, and on, since the turn-of-the-century.
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