mega super double announcement on monday?, page-9

Not sure about Prima being knocked back for US FDA phase III trials. I believe Prima expected that IIb would have to be done again to meet the US FDA regulations. I would like to know where you got that info, it may possibly be true but going straight to Phase III trials under the US FDA would have been a mighty step up from their initial Phase II trial.

I also understand that Prima plan to apply to the US FDA for recognition of their Phase III European Trials and believe that if they meed the US FDA's regulations this will occur. Therefore negating further Phase III trials and significantly helping in their ability to recruit patients with the increased target candidates/population. This information was from MR some time ago, so things may have changed.

I don't believe they have recruited/employed the people they have to design and manage these trials to then have to repeat a whole Phase III trial again. This wil be the benefit of overlaping phase III with the current phase IIb trial and reducing the time to commercialisation (all going well of course).

dc