I agree with previous posters about the rough-ness of the NMT approach to formulating the intervention design along with the controls and statistical inferences available to the numbers of participants over a time period planned; however, I think they have crossed that bridge, AGA notwithstanding, and have not had any DSMB problems, as revisions to the strength of the data are being made due to delays in getting trial subjects. The company now has a good bunch of long time participants that can easily replace numbers required for a shorter trial. The real crunching should be done in concert with the FDA devices folks, who may see the opportunity for enough robustness for a halt even earlier than planned for April or so. If that occurs, look for a very favorable market response. We are now 6 months away from the planned presentation of results, using a new statistical paradigm. Who knows. The results may be so good that they allow for an earlier announcement. I am holding here, with some angst, of course. GLTA