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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (8340)	1/17/1999 7:56:00 PM
From: Cacaito	Read Replies (2) \| Respond to of 17367

Xoma initial trial was set for 200 patients (and recruitment time of two years). Xoma extended recruitment to increase chances that for even a lower efficacy they will have statistical significance (clinical significance is clear: less deaths, less disabilities). The DSMB has not halted before due to a simple reason, the efficacy is not so great, maybe good but not so great. There could be a chance of an overzealous DSMB. But it is their duty to check for safety, halting comes out of overwhelming good data AND statistical significance. DSMB halted the Aids perinatal/newborns prevention trial with a 24% placebo vs 8% drug, an almost 70% reduction, and several thousands of patients. This is the type of results that is halted. Not a 23% vs 17% (an extreme example that xoma will need about 800 to 1000 patients to prove their case) Xoma decided on their own to have more recruits, and better data, the big influx of patients to trial from the UK give them that chance. In sum a conservative play by Xoma (not FDA), remember Xoma could stop the trial when they want. FDA does a great job keeping away none effective drugs and saves a lot of money. The FDA wants more control over the herbals and other remedies, but Special interest and the big government enemies are on their way. Some are arguing that redux and other drugs were later retired as a sign of an FDA that does not check enough. It is the other way they checked when data was available and then they acted upon it. One wants it both way: festively approve and let doctors determine, but upset with post marketing removals for lack of safety check that could only be known months/years/thousands/millions of patients and dollars later. Some of the side effects will not be known for months to years and thousands or millions of exposures. The FDA process is needed. Anyway a lot of people wants the FDA to be fast, but not one says take more money out of my pocket (taxes) and get things faster; Well, big pharma actually did and they are funding extra money and extra staff to the FDA, that is how the 6 months fast track review was created, part need of faster approval, part big pharma funding the FDA. Back to wait for trial completion and data publication. All disclaimers apply.

To: aknahow who wrote (8340)	1/17/1999 8:26:00 PM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

Anybody want to talk about what a great job the FDA does on efficacy of chemotherapy? Should the approval of a drug to fight Meningo. be any different? Do we really know the true efficacy of any product until it has been in the real world for sometimes years or decades? When was the true efficacy and wide usage in many different settings of thiazide diuretics discovered? Don't know what a thiazide diuretic is? How about aspirin? Now talk about discovered efficacy even after its very long initial history. Who would of guessed at all its uses in modern days. Ideal situation would be to have cheap small efficacy studies done but approval just on safety issues only. That way decision is between patient and clinician. Number one prescribed antidepressant in Germany is St. Johns Wort not Prozac or its siblings and cousins. Also in my world anybody involved in the approval process would be required to have a vast amount of direct patient care experience. Indeed, if someone is deciding efficacy, let them have the experience of signing death certificates and long term patient care in a variety of settings. Remember what the Ivory Tower pontificates now as fact, will surely change in the future. You can take that to the bank.