If the testimonial on the NTM board is representative of a . . .
statistically significant number of patients who enrolled in the Phase IIb study, it is highly likely that the Phase IIb results will stand alone as the measure of efficacy. The patients who enrolled were all pretreated with some form of the 6 month, currently recommended Rx for NTM. If Arikace knocked the CFU down two logs or to zero, this constitutes a new and better treament. Remember, there are no recommended treatments world wide for NTM. It is a vacuum for any therapy that works in a statistically significant fashion. This was the indication that I hoped would pan out and it appears that Dr. Kenneth Olivier of NIH has led the way.
In the investor presentation slides, there is a timeline. Estimated approval date and launch for NTM in the U.S. is 1H2015, with no P3 for NTM shown. Will Lewis has said that he expects approval based on the present P2 trial results. That suggests that he knows that Arikace is making a difference.
For those non-bacteriologists who need translation:
"CFU" - colony-forming unit is an estimate of viable bacterial or fungal numbers. Unlike direct microscopic counts where all cells, dead and living, are counted, CFU estimates viable cells. The appearance of a visible colony requires significant growth of the initial cells plated - at the time of counting the colonies it is not possible to determine if the colony arose from one cell or 1,000 cells. (Wikipedia)
"down two logs" means that the number of CFUs has been reduced by 2 decimal orders of magnitude, to 1% of the original count.
Rehd, Thanks for this post and many others of yours over the years. I'm glad that there is a medical mind here to offer opinion. While you often posted info which was way over my head which then guided me to do more research, I never understood those who vilified you for it. Keep it up.
" I never understood those who vilified you for it."
- there only ever was/is one person doing that: Fudfighter and his/her aliases
There are (at most) only about 20 people who post of this board, few if any (except for Rehdvm) have anything useless/valid to say