Ann: Chairman's Address to Shareholders, page-26

Oh another point to be pedantic about something Mr Cod said:

RT's point about the trial statistics was that the statistics weren't strong enough due to the small trial numbers for the traditional type statistics the FDA prefers. RT pointed out that they are very confident that their statistical analysis is robust, it's just that the FDA didn't like the permutation analysis methodology.

As to whether that means that future trials would have to be substantially larger- yes they might. RT conceded this as a possibility but again until the FDA meeting it's all speculation.