the facts about prr trials

Having read the pure speculation I think it is important to provide the facts. See below:

Prima advises it's protocol for CANVAS has not changed. Previously 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.

The phase 2 elements relate to the following:
• Prima has added a 3rd manufacturing centre in Europe that has not been a part of earlier trials
• There have been ongoing adjustments in manufacturing processes that should be validated in a good number of patients
• Earlier CVac trials, such as the CAN-002 study which was a phase 2a trial, were conducted in patients with aggressive, advanced cancer. CAN-003, a phase 2b trial, was the first study conducted on patients in remission - as data indicated this would be the optimal treatment time for patients. As such, there is still an exploratory element to the CANVAS trial in this specific patient population.

The phase 3 elements relate to the following:
• As manufacturing validation is accomplished, the Company can confirm the consistency of the CVac product across different manufacturing centres with a very high level of confidence
• As data is available from CAN-003, this can validate the confirmatory nature of CANVAS
• CANVAS enrolls a sufficiently large number of patients that clinical and statistical significance may be achieved if CVac works as intended.

clinicaltrials.gov is a US based website and the obvious lack of easy designation has resulted in the change you noted. In our case (but not only in our case) the different regulatory authorities apply slightly different classifications.