So 10 patients in Adelaide with MPS I for the p2 trial? I wouldn't think that is enough to get approval. Surely they'll need a few more sites and a few more patients.... With only 10 patients required for the p2 trial, one would think they already have the recruits lined up and nearly ready to start There shouldn't be any reason for this to drag over many months. Also data collection and analysis of results at the end of the trial should be quick. And as the study is not blinded, and there is no placebo group, it would be nice to possibly get some feedback somewhere through the trial....
Chart, page-1414
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