Will Lewis is the only person who can overcome the insanity on . . .
1. No difference between 28 day on 56 day of and 28 day on 28 day off Rx with Arikace in CF/Pa. Hopefully WL will comment on the extended treatment study, at least in-so-far as enrollment. If that enrollment keeps up, it goes without saying that Arikace has at least met the TOBI equivalency. If the 28 day on 28 day off prevents the dip in FEV1, then SID treatments and biofilm penetration will be the new focal point for inhalational antibiotics. This opens the way for a US filing using the same data.
2. NTM got 2 logs of kill and/or a significant percent eradicated. This expedites EAP and move to expedited review.
3. WL will suggest the long term look at the biofilm penetrating liposome Rx using the newly hired scientists and summer interns has begun and that they are pursuing a couple of candidate formulations that will present new IP. Along these lines, they may be looking for a partner to formulate an inhalational drug combo that will capture an new niche market based on improved safety and efficacy of a pulmonary drug.
The efficacy of Iplex for MDC1A is just as obvious as the efficacy for Duchennes. Both are specific muscle weakness disorders with no neurodegenerative component. Dr. Moxley conducted the study on MMD which has several different levels of neurodegenerative and muscloskeletal disease. That is why Iplex did not stand a chance of attaining the primary endpoint. That ship sailed.