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

To: Miljenko Zuanic who wrote (2338)	9/9/2002 11:38:59 PM
From: Cacaito	Read Replies (1) \| Respond to of 2515

Concentrate in Erbitux...ok no more sam...Fda found a 10.5% response rate, Fda specifically demanded that a minimum 15% of subjects get a 50% tumor reduction. You are claiming that even that response rate will be consider "seriously" by the Fda (I do not agree). The purpose of accepting this type of evidence is to accelerate drug development and approval due to the difficulties on Cancer trials when prologation of life (survival) is the main goal and the true meaure of efficacy (unless one includes quality of life). The premise is that if the terminally ill subjects do show a response, then when the drug is tested in the less ill ones it will show a survival increase effect. It has worked in the past, it does not warranted it will in every drug. The trials with erbitux has shown so many problems with wrong data that to accept those proxy kind of data is much more unpredictable. Then the Fda will have no recourse but to demand further trials (by the way just check Avastin failure in phase III after much better data in phase II and without the mess of the erbitux trial). It is the nature of a good placebo control ramdomized trial to CLEAN the panorama, there is a cemetery of drugs with reasonably decent phase II data (especially the ones without blindness and lack of control) that never pass the rigorous testing. My point is that there is ZERO SOLID evidence that erbitux works (besides animal data with their implanted xenotumors that even tylenol could cure). I do not believe in a single anecdotal case with erbitux. The trials so far has been failures. The one that was going to be pivotal for quick approval is completely rejected by the Fda, there is no salvation possible for the Colon Ca trial, maybe the german data will show something? I strongly doubt that. If you have evidence to the contrary,please, provide it. Very simple, your level of tolerance to expose your money accept more risk than mine (in this case). Time will tell !!! Regards,