expect another failure, page-9

From reading the report, it seems as if the FDA will reject the application. This is madness, and can be blamed on:
a) The inflexible nature of the FDA analysis and;
b) The absolute morons who wrote the pre-trial analysis plan. The report seems to suggest that now the trial is done, you can't change the analysis to be more accurate.

The problem with the current analysis is that it counts those who drop out of the trial as "failed to treat." Yet, because the Bronchitol treatment is evidently not pleasant, more of those who are on Bronchitol drop out than those on the control.

Thus, these people automatically count as "failed to treat" even though the reason that Bronchitol did not help them was because they did not wish to continue using it. If you don't adjust for this, then "statistically" Bronchitol doesn't work. This is despite the fact that it does work if the patient actually uses it.

Thus, we literally have some highly paid scientists, who we as shareholders are paying, as well as the (also well paid) management, who didn't get around to thinking of this before throwing millions of dollars at not one but two trials. So just in case you were wondering, yes, they are treating shareholders with contempt.

On the other hand, Bronchitol does actually work, and if I was an American and my child had CF I would be mighty pissed off at not having access to it.