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Decan
I was referring to the PRR announcement on 11 May 2009. It says they are in the final stages of US FDA approval and eventual commercialisation.

It says Rogers is in the US to progress PRR's final regulatory submission for IND with the US FDA and its plans for the the Phase IIB/III Pivotal Trial.

The reason I refer to the linked information about IND at the FDA site is because it says in part:

"An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap..."

Do you think the juxtaposition of the NDI application and the pivotals trials in the same sentence is referring to the NDI application in the US and completely separate pivotal trials being conducted for an unrelated purpose?

It pains me to recognise that the PRR announcements are unfortunately written in a style which is open to interpretation and if what you say is true the picture I have imagined is quite different.

Say it ain't so, Joe.