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  • tredleon tredleon Jan 12, 2010 1:19 PM Flag

    Press Release Realities

    You're right - this is similar to how cancer trials/therapies evolve. Treatments work for some, but not others and there is no way of predicting who will benefit. So when something new comes along, the FDA typically only let it be tested on the sickest, end-stage patients, as they don't want to deny (or interfere the treatment regiment) less-sick patients the opportunity to benefit from existing treatments. The fact that the FDA is allowing this "less sick" patient group be involved in the trial means they are definitely comfortable with the safety side and probably are saw enough efficacy to convince them that it is better than a 50/50 shot that the patients will benefit.

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