While the negotiations about CF/Pa go on, the emphasis for Arikace has clearly shifted to NTM. WL is an excellent speaker who keeps hammering the strongest points about Arikace:
1. Once per day. Guarantees that patients will receive treatment.
2. Neutral distribution to the lungs for thorough distribution.
3. Uptake by fixed macrophages where the NTM offending bacteria are concentrated.
4. Improved quality of life by virtue of decreased bacteria (most likely, but not shown YET), improved FEV1 and "feeling better."
5. These therapeutic improvements among the worst NTM patients that have just come off 6 months of other therapy.
6. And 25 of 81 plus have elected to continue under EAP.
For the first time also, WL stated that they are discussing results biweekly with FDA.
If I was under Dr. Kenneth Oliviers staff and the "qualitative clinical data" was that encouraging, I would ask to unblind a statistically significant subset of data (the first 50 patients) and look at the primary therapeutic effect . . . decrease in NTM. Like most infections, the earlier the infection is treated, the less lung damage. Lungs scar with chronic infections and scars never function as normal lung again. So if the first time a patient is cultured positive for NTM and treated with Arikace, the probability is they might get treated again in 6 months, but the chronic lung scaring would be averted.