What do you mean by 'trust' in the context of your response?The...

What do you mean by 'trust' in the context of your response?

The data submitted to BSI in support of the CE mark application was as resquested/specified by BSI and relates to safety and progression free survival in conjunction with the chemo standard of care. Do you not trust the data itself or the fact that it relates to a sample of 50 patients?

As far as the study is concerned, the results present some statistically significant impact on tumours, including downstaging them to be operable. Safety relates to the implanting procedure and the implanted device itself with the study reporting no significant safety concerns attributable to either. Again, are you not trusting Oconsil managment, the study findings, or the fact they only relate to a sample of 50?

Simple fact is that pancreatic cancer has a one-year relative survival rate of 20%, and a five-year rate of 7%. Current treatments have side-effects and there has been no advancement in treatment for many years. If we don't trust statistically significant findings for 50 patients, how is waiting for a larger trial going to help patients with a pretty shitty prognosis anyway...