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Biotech / Medical : Techniclone (TCLN) -- Ignore unavailable to you. Want to Upgrade?

To: Maurice Winn who wrote (3122)	6/2/1999 9:36:00 PM
From: Bob L	Read Replies (1) \| Respond to of 3702

I tend to agree with most of what you say. But I think the FDA might not be the barrier you think it is. There is a procedure for use of drugs before final approval. Its called Treatment IND, commonly known as "compassionate use." It is possible to get approval for treatment of individual patients by individual doctors. I looked into this a couple of years ago. The FDA requirements, on paper at least, were fairly reasonable. However, it is difficult to find doctors who are interested in pursuing it. Occasionally drug companies will get approval for treatment of a class of patients who for some reason are not eligible for the formal trial. A 1996 puff piece from the Clinton administration on FDA improvements claimed 20,000 cancer patients had been treated under the program since 1987. Not all that many really, for a ten-year period. And only 500 were individual patient applications, as opposed to drug company applications. They didn't mention how many, if any, they had denied. When I asked an HMO oncologist about Treatment IND, he acted like I had recently arrived from Mars with strange ideas. Doctors at a major research university hemmed and hawed and said there was too much paperwork, but it sounded like they had never tried. I also know that Coulter told a lymphoma patient who was barely ineligible for their Bexxar phase III trial that Coulter was "too small" to provide any assistance for individual patients. (The patient had a platelet count of 95,000 when the trial protocol required 100,000). I don't know if anyone has ever approached Techniclone for help with Treatment IND. I suppose we have pushed this off topic discussion far enough, though. I appreciate your comments, but others probably would prefer to read something about Techniclone. Cheers.