food for thought, page-12

Great post brainybull! I know I have posted this before sometime ago, but thought I would re-post as it is relevant to your comments. Sorry it is long, but worth the read.
I received these responses to my questions from MR and Dr Frazer respectively via email on 25/8/2011:

From MR:
"Our main focus is on the markets of US and EU and is the focus of our upcoming clinical trial of 800 patients.

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.

For Dubai/Middle East we will broadly provide CVac to mucin-1 positive cancer patients. This is a pilot commercialization program that will give us important drive to what works in cancer patients, what oncologists prefer, how different patients react, internally gearing up the company to support other commercial activities if we are successful in other jurisdictions etc. This is a long-term strategy we have in place to support our global execution.

We have done numerous clinical trials and patients outside of clinical trials over the past 14 years across patients at different stages of disease but we must focus on a “label” for US and EU approval."

From Dr Frazer:
"- Have you done any testing pre chemotherapy? No
- If so, can you tell me what the results were?
- If not, do you plan on conducting these trials in the future? After we obtain approval, we may broaden out the times of administration in additional clinical studies.
- What would be the process required to gain FDA approval, ie full PH I, II AND III? It's a difficult question. We'd probably need to start with concomitant administration with chemotherapy and work back from there.
- Will the current Ph III testing only allow you to administer CVac post chemotherapy? For EU, US and Australia-Yes