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The typical clinical trial model may not be best suited for generating evidence that a drug is safe and effective against diseases where patient enrollment can be difficult and diseases progress slowly and unevenly over a long period of time, according to Steven Grossman, who worked on the original Orphan Drug Act in 1983 and is now a policy and regulatory consultant.
FORBES: Orphan Drugs: 'Rare' Opportunities To Make Money
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Not to treat Mr George's acquittal as a miscarriage of justice "went behind the decision of the jury that acquitted him" and failed to take account of the fact that no safe conviction could ever be based on the evidence against him, the QC said.
BBC: Barry George loses compensation case
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It is made by Bayer and its advantage is that it is already widely used against bronchitis, so it is known to be safe.
ECONOMIST: Tuberculosis