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

To: The Fox who wrote (2058)	2/18/2002 2:57:58 PM
From: Cacaito	Read Replies (1) \| Respond to of 2515

Mr The Fox, research protocols are PUBLIC documents, it is so to protect the public. IRB comittes (Institutional Review Boards) are formed with different members of an Institution (hospital, clinic, laboratories) and Community members. ESPECIALLY INDs (investigational new drugs) and the ones that go all the way to NDA or BLA. Many protocols could be found in public presentations including the ASCO that gave fame to now infamous Erbitux, and many of the presenters share information about the design and results FREELY up to a point. What is PRIVATE information of companies is the FDA decisions and communications. Once the company publish any part of a document (the RTF in this case) is a public document jAND is material information that belong to sharholders, do not come with the paternalistic idea that the company must or should keep details from the public, the company give it to the analyst and venture capitalists all the time, shareholders are not idiots, except the ones who gets outraged when the information is rightly OUT. Anyway, the RTF results were probably received by phone a day before the letter (fax on 12/28/01) Imcl waited until 12/31/01 for press release. Copies were not out until January 7, 2002. If anyone new information before 12/27/02 via Imcl leak (most probable source), or FDA leak it is wrong to use it for longs or shorts, it is insider trading. No evidence is available of that. The companies use and ABUSE the privacy of the FDA communications with lots of leverage to negotiate with partners, to control (manipulate) the information to analysts, venturers and especially the public investors. THAT is the source of problems, not any leak. Some are claiming for full disclosure of FDA companies communications, but it is the companies that are opposed the most. The FDA has a large and very long record of keeping tons of information out of the public CAUSE it belongs to companies. Finally, the RTF is out, it is probably a very lengthy document that mentioned the whole protocol, their objections to design and execution, results and commentaries about how to address the situation: MORE TRIALS ARE A MUST before approval. It is Imcl that gave the wrong spin negating the need for new trials and getting caught in the alleged lie. Strong case for Class Action suits, BMY and mercky. So why to be surprised when the RTF copies are all over and anyone could evaluate it freely and legally. If Imcl is so sure of their original RTF, WHY IS NOT PUBLISH BY IMCL? because a true copy is already out !!! Patients records are not going to be published without consent from the patients. The results of the study are anonymous and mix analysis, no way to track a single subject via the RTF. Each hospital/clinic/clinician/pharmacy individual record is protected very well. Examples: 1. xoma denied the protocol of their Neuprex meningo trial pIII, it was public in the WWW in a fellow presenter at a London Institution, that the thread got the protocol was completely legal, companies think investors are stupid. 2. The Ralph Nader group that track ethical problems in protocol lead a very public fight against Discovery Labs because of the placebo group in Latin American babies that predicted 17 to 40 babies will die and demanded and won a change in the protocol to compare drug vs drug, not drug vs placebo, despite the company investment in several poor hospital that warranted hundreds or thousands of babies would be saved with original protocol. WELL the 17 to 40 estimated babies WILL ALSO HAVE THE BEST CHANCE! Imcl can not have it both ways, and it is not now, and it will not !!! Secret negatives and Public positives is FINITO for Imcl, the RTF (and much more later with SEC/FBI/Congress investigation) is out !!!