Thank you solusnauta...nice work! We must continue to ask these...

Thank you solusnauta...nice work! We must continue to ask these questions not only of PRR management, but also of the FDA and other relevant bodies in order to help expose the breathtaking flaws in the system IMO.
Further to your correspondence with Neil, the following is what MR had to say on the matter some 12 months ago:

"The basis of this study for these markets provides a product “label” by which the CVac can be officially used. Our label is aiming at 1st line remission of EOC ovarian cancer patients, post-surgery and chemotherapy. Our input for this study is from a body of scientific literature, input from our internal clinical team(who have a depth of experience in getting drugs approved in US and EU) and set of medical/scientific/regulatory clinical advisors, experience of cancer vaccines success and failure in the clinic, feedback from EU EMA and US FDA regulators and their advisors. In our opinion this is the sweet spot.



One must balance the window of application for a label to running the clinical trial cost and time for the application with the US and EU. What is stock standard in the biotech industry is to apply for a label and then run clinical trials after marketing approval in US and EU for a “label expansion” this can be done on anecdotal evidence typically from oncologists using the product outside of label. In the US for instance it is ok for doctors to use a drug off-label and is very common, however, it is illegal in the US for a company to market a drug off-label. The remedy to increase the label is to run other studies."