When reading the Deutsche Bank Presentation one briefly mentioned point stood out significantly. I am not sure if it has been mentioned here, I haven't noticed as yet.
My point is, I believe all previous (or at least most) information regarding Prima's Phase III trial has only mentioned Europe and the EMEA. Thus raising issues or concern about them meeting FDA regulations for approval and the possible need to duplicate or re-do Phase III trials in the US. My belief has always been that the trial will be designed to meet US FDA regulations anyway.
However, now go to page 12 of the presentation (page 14 of the announcement) - Value Drivers..., and see the following:
* Phase III study to be conducted in Europe, US and
Australia commencing recruitment by Q3 2011
Yes, Phase III to include the US. I believe this can confirm no further Phase III trials and that Prima plan to tie it all up in the one, removing the cost and time involved in further trials.
When you didn't think it could get any better......
Regards
dc
deutsche bank presentation & phase iii
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