Just listened. Aside from what others have mentioned as interesting, here are two others I found interesting: WL said around the 2 minute mark "when approved" which seems a bit more optimistic than in the past when he (if I remember correctly) would use the terms "if approved." Also, The roundtable with ex FDA came up with 3 alternate pathways to approval that did not require phase 3.
Lewis knows his "stuff" and his energy and optimism was at the right level. He suggested quite a few times for "anyone" to listen to next Tuesday's presentation (Dr Olivier??) where we will get an update of the next 84 days of the NTM study and the PH 3 CF ongoing expansion study in Europe. CF approval in the US is not on the table but it is in Europe - NTM in US and Europe. He also emphasized we treated the worst NTM patients. The patient that died (treatment arm) hurt our primary goal real bad and if that patient (death unrelated to Arikayce) was removed from our score, we were in good shape (.2 or near that score). My bet is we get approval for NTM with an agreement of doing a PH 3 trial of other NTM patients looking for other measurements for potential expanded treatment.
In his brief mention of the primary endpoint design (penalty assessment) appears to me he was admitting it was poorly designed. If so, Is this the first time this has been indicated publicly? I wonder if this impacted Dr. G's departure.