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

To: The Dodgy Ticker who wrote (1861)	1/22/2002 11:42:59 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 2515

Very objective article. I will add: <<If we put together all that has been said up to this point by everybody, including the firm’s management and Dr. Waksal himself, we develop the impression that the problem is about the company’s failure to provide documentation on the "refractory" nature of patients enrolled in the trial. The word nature is still subject to various interpretations, the most optimistic would be that the firm has, indeed, proven that the patients were refractory to chemotherapy, yet, some required details were still missing. Another possibility suggested by some analysts is that, after a successful presentation at ASCO, “ImClone presented an optimistic timeline of Erbitux approval based on Phase II data,“ as in the case of Gleevec developed by Novartis?!>> Per protocol and trial execution, pts are stratified into two equally size group: A)PROGRESIVE after irinotecan and B) STABLE after minimum 12 weeks on irinotecan. This was done for a several reasons, and FDA agree with. So, refractory is not valid for at least 1/2 of the enrolled pts, but not based on pts documentation. Based on enrolling criteria. Article is correct, all MATERIAL info were available before BLA is filed, ONLY ONE HAVE TO SEARCH FOR IT. Miljenko

To: The Dodgy Ticker who wrote (1861)	1/23/2002 12:00:55 AM
From: Cacaito	Respond to of 2515

Prohost article is poor and plain soap opera dramatics! Their whole argument is that everything has been ok with all the interested parties so everything must be ok, and it is not. There are questions about the so called "tumor regression of 50%" some are saying the imaging studies were sent to FDA but not the calculations, some said the work was done, but the "faulty application and screwed up" came from Sam words to the H&Q. And Prohost ignores that the company said "no new trials" only for the RTF to claim that new trials are needed. That there are concerns since August 2000, and Prohost expects that the presentations to the scientific conferences are the word to follow. An FDA filing is full with 10s of thousands of pages of documents. Prohost even claims the the FDA did not complain publicly before (neither it did now, it just rejected the application), the company owns the information, and the company must release it. Another one was McCamant in same kind of swing.