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

To: Arthur Radley who wrote (2041)	2/16/2002 10:45:14 AM
From: Cacaito	Respond to of 2515

TD, some in yahoo are saying that the trial "protocol" was leak. Trial protocols are very public documents, do you remember when xoma denied the protocol and it was found very well in the open www from a London fellow presenting it to the world! Anyway, the RTF must be a lengthy document with the protocol on it very well described.

To: Arthur Radley who wrote (2041)	2/16/2002 12:33:04 PM
From: Cacaito	Respond to of 2515

Erbitux failure is very probably a very intrinsic aspect of the drug, not just the trial. Subjects were wrongly included/excluded in the trial. The % with tumor shrinkage was lower. Documentation/calculations were absent/defective (not x-rays, no ct scan images, no calculations, just the results) Zero survival increase (not designed for it, but it did not happen anyway if it would have occurred they for sure would have included). Wrongful account of deaths 3 reported instead of actual 21. The protocol was to report any deaths within one month of participation in trial, in a double-blind placebo-control study this could turn to be a lack of mortality reduction or worse, subjects will be follow for months to years. If a biotech has this trial data to try a pIII, you will not find any pharma willing to sponsored it, it just happens that pIIIs are on the way. The claim responses at best match what irinotecan alone will do, this is about the combo colorectal cancer study reported 22.5% responses. The "Erbitux solo trial" responses drop to 10%, it has not been review by the Fda, who could assure that it does not have all the faults of the combo one? FDA ask for 50% tumor shrinkage in at least 15% of subjects for combo trial. There is not even a demand for high statistical significace. A pIII will demolish the results, not confirmed it. A survival goal trial is out of question, no evidence at all it could prolong lives, and it will now be demanded to show increase survivability. The 10% solo trial could be good, IF they get the same response in double blind placebo control study AND statistically significant and increase survival, that is years away. The Fda will demand MORE for next trials, not just "shrinkage" they were burned by this Imcl, lots of bad publicity for "keeping the drug from the dying", Well, PROVE that it will decrease mortality. The Feb 26 meeting is a death foretold!