orphan drug status, page-3

I talked to MR not more than a few weeks ago. He told me that ODS would come more or less automatically soon after trial approval but not before. So this is now basically due.

My personal view is that CVac having ODS (which he seemed to think was inevitable) is pivotal to the early success and major potential this drug has to offer. ODS changes the endpoint criteria, speeds everything up (less trial patients) and endorses (as far as possible short of good results and FDA approval) it as a very much needed drug.