questions re phase 3 trial, page-6

Below may be from press release referred to above:

"The optional pharmacokinetic and cardiotoxicity sub-study conducted along with this pivotal trial is intended to provide further confirmation of HA-Irinotecan's safety profile. The additional 25 patients enrolled served to boost the size of this sub-study, increasing patient numbers to around 90% of the sample size targeted by Alchemia. Supplementary patient enrolment also increases the statistical power of the whole trial, and improves the predictability of when the primary endpoint of progression free survival is likely to be met.
"The rapid recruitment of these additional 25 patients will allow Alchemia to determine the success of this pivotal trial in the first half of 2014," said Dr. Tracey Brown, Chief Scientific Officer of Alchemia. "We have been encouraged by the initial statistical review and modelling of the available blinded data, as it suggests that patients as a group are continuing on treatment for longer than anticipated before their disease progresses. Additionally, we anticipate these further recruitments will provide enhanced validation of the safety and efficacy of the HyACT platform technology."