Re: Just a quick question
Bo, I remember the FDA stance on the 6 minute walk results, and it bothered me at the time as well as recalling what was said to this day. The culture converters on the Arikayce arm showed a stat-significant improvement in the 6 minute walk. However, the FDA wasnt willing to separate the converters from the non-converters who were on Arikayce, This lumping of the entire Arikayce arm population did not provide a stat-significant improvement. Well, naturally! In my mind, this emphasized the importance of culture conversion! I still dont get the FDA's view on CC not being an acceptable endpoint. I would think that simply being able to drop (any or all of) the systemic SOC drugs (with all their long and short term ill effects) would be the best endpoint of all.