north american investment partners, page-6

agree guys

I like this ... it makes me very optimistic about potential for significantly reduced phase III cost.

"Based on discussions with the FDA, instead of running a 120 patient trial as was considered at one stage, the company may only need to conduct a randomised 60 patient trial, with 35 in a treatment arm and 25 in a standard of care arm ( e.g. second line therapy that includes a platinum based drug and taxol). The trial is likely to require 15 sites in the US and 15 sites in Australia and New Zealand. While the primary endpoints have yet to be made known, they will not include stabilization of CA125 biomarker levels as occurred in the Phase II trial.
The trial is likely to commence as a Phase IIb and roll into a Phase III trial. The company anticipates receiving the IND acceptance by June with enrollments to commence in the September quarter."

from Bioshares April 2009 ...

http://www.primabiomed.com.au/projects/prodDocuments/Bioshares308.pdf