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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Andrew H who wrote (3678)	12/6/1997 8:06:00 PM
From: CYBERKEN	Read Replies (1) \| Respond to of 9719

No question CEPH showed arrogance (& probably CHIR too), and no question that that's a bad practice in any business. But for sheer arrogance: try to beat the US Food & Drug Administration. It's a trait that makes them the envy of all the other power-soaking agencies we've negligently allowed our Congress to create and perpetuate. Therefore they might just identify a little with the 2 drug companies. Anyway, the trial results and the endpoints indicate a very iffy probability for approval based on what we generally see. The condition of a post-approval (phase IV?) test to determine effectiveness might be able to put myotrophin over the top. The potential of the FDA shooting itself in the foot (PR wise) with a public that doesn't follow this stuff as closely as we do definitely has to be considered a factor in their decision. I have no doubt it's what made them encourage the companies to resubmit. And while we could call it bad science to change the question as a result of the tests, it still relieves the pain and immobility of the sufferers. Perhaps it's splitting hairs a little too much to disapprove on the basis of sloppy execution--as opposed to letting the patients and doctors decide whether or not buy the drug. Anyway-I don't think it's entirely settled that myotrophin doesn't slow down or stop ALS. Therefore why not put out it on the market based on what is known to contribute (relief) and continue the study? Only in Washington would that not be called "progress".