the facts about prr trials, page-13

Hi Kbear

I think this issue has been a red herring all along. And I have been convinced it is a data entry and/or computer interface problem with the US system. Just as the company is indicating in their correspondence to you and is saying that they will fix.

But I am confused by one thing. Why does the EU trial registration site show Canvas as follows:

E.7.1.3.1 Other trial type description:
E.7.2 Therapeutic exploratory (Phase II): Yes
E.7.3 Therapeutic confirmatory (Phase III): No

In light of the company’s statement that “CANVAS has been termed by the European Medicines Agency (EMA) as a phase 2/3 trial, which means there are both phase 2 and phase 3 elements to the trial”.

I don’t attribute any negative connotation to this at all. But I do find it perplexing. And I suspect that there are some subtleties with the trial design of Canvas that are quite opaque (and probably will remain so despite our best efforts) to anyone outside the PRR scientific advisory and their consultant methodologists.

Regards Southoz