how huge will expenditure be peace and where do you get your info from about the trial costs.i can tell you my understanding is that the 12 mill finding will be enough and the trials will be on reduced numbers as stated in the recent bioshares article.i have confirmed this with prr management but maybe you have somewhere else that you get your info from.maybe you yourself should make some calls before throwing figures like over 1 billion shares around and huge costs.below is part of the bioshares article and the link if you would like to do some research.the fda are indicating a lesser amount of trial patients are required.and forgetting all this trial costs prr may just sell cvac quicker than any expect.
Interestingly Prima Biomed now looks set to follow positively in
the path of Dendreon and benefit from the questions posed to
Dendreon by the FDA regarding manufacturing of autologous
immunotherapies, with a clearer pathway mapped out. Prima will
also be using the same manufacturer that Dendreon has used.
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.
bioshares link:http://www.primabiomed.com.au/projects/prodDocuments/Bioshares308.pdf
Add to My Watchlist
What is My Watchlist?
