And if we are right about the outcome of the HEAT Study, we have every reason to believe that we will -- believe we will be bringing to market one of the most important new drugs in a generation, that's ThermoDox. You don't have to take our word for it. Look at the support we've had from multiple regulatory agencies around the world and, in particular, from the FDA. We've negotiated an SPA. We have Fast Track. We have Orphan Designation. We have an agreement to file using a 505(b)(2) approach, and we are candidate for priority review as a function of the strength of our data. The reason for this, well, it's clear. HCC is an enormous unmet medical need.Let's go through the facts because I think you'll agree with me, they are sobering. ThermoDox's principle indication is HCC, the world's fifth largest cancer and a disease of significant concern within the global oncology community and public health agency. Incidents is approximately 28,000 in the United States. It's tripled in incidents over the 30 year period from 1977 to 2007. There are 40,000 incidents in Europe, and is growing rapidly at 5% worldwide from a base of 750,000 new cases annually.
Celsion Management Discusses Q2 2012 Results - Earnings Call Transcript
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