Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Fred Levine who wrote (1979)	2/9/2002 2:27:38 PM
From: Cacaito	Respond to of 2515

Fred Levine: 360,000 pages of data were submitted to the FDA from Imcl about the Irinotecan/Erbitux combination treatment trial in alleged irinotecan subjects and the only claim was "tumor shrinkage", not saving lives. Even that goal was not proven. FDA rejection of application means NOT PROVEN efficacy. The clinical presentations are as honest as the company presenting it, AND the best is presented, the full data is not, the public TRUST that the presenters are honest. The FDA has a big hand on all aspects of the trials. AND your 5 out of 18 who remitted completely (part of the combination or solo trial?) does not mean survival, it could be so or not, it is not prove. Survival is measure usually at 5 years, less for terminally ill subjects. To investigate a cancer drug like Erbitux takes many years. The FDA allows that shorter trials are accepted EVEN the ones with lack of concurrent placebo control subjects and blind assignments like the Erbitux trial was, it is a measure to help save lives until further proofs are confirmed later during marketing phase. But, Imcl abused it to hype and dump stock, at best to irresponsibly mismanage the trial. You can not have it both ways, Imcl is great, Erbitux works, Sam is astute, Saltz is prestigious and brilliant but when the whole combination produces a mismanaged trial that DO NOT provides the evidece of efficacy THEN the Fda is the problem.

To: Fred Levine who wrote (1979)	2/9/2002 2:32:44 PM
From: Cacaito	Read Replies (1) \| Respond to of 2515

Fred, Why is the original RTF not published by Imcl? Why did sam do not deny the published excerpts of the RTF copy? According to the RTF, since AUGUST 2000 they have being FDA concerns about the whole trial design and execution, THAT was never given to the public by Imcl, neither sam. sam is very loquacious " We prepared faulty application, and We screwed up", but he did not say anything when He was busy trying to get $70 per share, neither when dumping $150M (after borrowing money from the company to exercise options).