ruflair---I suppose the FDA could delay their ultimate decision until the results of the Ph. III trial are available. I would think that they would do a risk/benefit analysis, and that they would probably approve the drug now because of the dire straits of the patients. They could always rescind their approval at some later date based on more data. The likely mortality of the patients for whom this drug is being considered is the best argument for approving it immediately. JMHO