The RECIST criteria was established for a specific purpose and that was to provide a standard benchmark for helping assesing the efficiacy of cancer treatments. It is widely accepted throughout the pharmaceutical industry and across most regulatory agencies.
PRR in its March 2006 trial for CVAC delivered a so called successful phase IIa trial ONLY because it set the benchmark for responses at incorrect levels to best practice according to RECIST.
If PRR had followed RECIST in its trial protocol it would NOT have meet its primary endpoint.
The data generated by PRR's phase IIa trial was not sufficient for a partnering deal with Biomira back then and it remains the case today.
PRR needs to undertake ANOTHER phase II trial to generate statistically significant data according to the RECIST criteria, otherwise CVAC will never get required funding for a pivotal phase III trial, clear and simple.
IMO a well constructed phase II trial will cost $10 to $20m and take 2 years + to complete.
ANY shareholder please feel free to question young Marty or even Ian Frazer re this point and post your reply.
The directors are taking PRR holders for a ride here IMO.
cheers
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