John, I don't follow LDAKA that closely, and had trouble finding some of the earlier press releases, but here's my quick take (and someone more familiar with the numbers can correct my initial take if its wrong).
I haven't done the statistics in awhile, but I think that the range is also required. However, with 750 patients and a reasonable tight range, I suspect that the difference between Lidakol and placebo is in hours not days (if each group was about 375 patients, I would be surprised if the placebo was 5 days or more). The August press release discusses untreated patients, not placebo treated.
I haven't seen the earlier press release in over a year, but as I recall, there was no difference between the placebo and Lidakol (in fact I think that the placebo might have been slightly better). The August study found a sub-population that did better (p=0.48) than the placebo #2, but since the entire population showed no significant diffenence, then another subgroup in this study probably also did better on placebo #2.
Thus, if Lidakol is approved, LDAKA could have three products. Placebo #1 was as good as Lidakol in the initial Phase III studies, while Placebo #2 was as good as Lidakol is one or more subpopulations, so LDAKA could file NDA's on each placebo, arguing that they were just as good as Lidakol. |
