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clock Created with Sketch. 01/09/18
16:37
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Originally posted by hottod
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In the announcement of the licensing deal with Acadia it was stated that the Phase 3 trial of trofinetide in Rett syndrome would enrol ~180 patients. Assuming a 50:50 split between drug and placebo that would be ~90 patients to be dosed with trofinetide over 6 months. If manufacture of the drug for the trial is costing AU$6.7 million, that would average out to a cost of AU$74,000 per patient for 6 months of drug supply, which seems exraordinarily high to me. Of course, it's possible that they could be stockpiling product in advance for future planned trials. But allowing, conservatively, a guaranteed 2 year shelf life for the lyophilized powder, and taking into consideration that the Phase 3 Rett trial won’t complete before late 2020, I’d say there’s a solid chance that the next trial in Fragile X will overlap with the Phase 3 Rett trial.
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