Ann: Firebrick Pharma Investor Update on Key Projects, page-3

Titans,
The reason is not at all due to the larger sample or discriminating minor effects. It really relates to the labelling claims we want to secure upon approval, notably in Europe. In the original protocol, we defined a primary endpoint (impact on GSS in the ITTi) and a series of secondary endpoints. The statisticians have recommended what is called a hierarchical analysis, whereby after testing for efficacy on the primary endpoint, we nominate one of the secondary endpoints - in this case, the impact on GSS in the ITT - as a 'key' secondary endpoint. This gives us a greater chance of making therapeutic claims covering all people with cold symptoms, not just those with a confirmed viral infection (assuming both endpoints are positive and significant, of course). Statistically, it also means that both endpoints can be tested the p<0.05 level of statistical significance. It is a minor, but very helpful modification. And I hope my explanation is helpful and not too confusing.- statistical analysis of clinical trials can be quite complex.

PM