Ann: EU Marketing Authorisation Application Revie, page-3

re: Ann: EU Marketing Authorisation Applicati... Hi All

My understanding is the EMEA are not looking at the 7.3% from baseline and saying that is not enough, they looked at the 3.8% movement versus control and said that was not enough.
This is 26 weeks data over two trials.

The reason for the variance is the placebo in control group of 50mg actually worked in some to the degree of 3.5% overall. In other words those on Bronchitol improved 7.3% while those on placebo also improved 3.5%.

So rather than continue an argument with the EMEA about active placebo etc, they can model on the same trial data the effect for patients who show a response after 6 weeks treatment. That will increase the overall % in the baseline group which will bring up the % variance versus control.