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

To: CYBERKEN who wrote (3677)	12/6/1997 7:21:00 PM
From: Andrew H	Read Replies (2) \| Respond to of 9719

>>Line of least resistance for the FDA::approve myotrophin and require that the label explicitly say that it's purpose is for relief of symptoms, rather than treatmemnt of the disease. If CEPH and CHIR then want to market it as a treatment, they'd have to do another trial and get approval for a label change. IMO: That sounds like a good, fair deal all around. Do you agree?<< A well reasoned post, Ken, except for the garbage about the left wing media (:>) The only problem I have is: can and/or would the FDA do what you suggest IF the relief of suffering was not an endpoint in the trials? Do you know if it was? To claim this after the fact would be bad science and not justify approval in the FDA's eyes, I think. I agree that for humanitarian purposes, they should approve the drug. And they may be looking for an excuse to do so. However, CEPH's and CHIR's arrogance throughout the process (especially CEPH's large option pruchase) will not help.