PharmaCyte Biotech Inc (PMCB)

[DragonBear]

if you are gonna keep bringing this up

EMA did grant Austrianva a Phase 3 trial

Provide the link from the EMA giving approval.

EMA would only grant a P3 if production was in place

In another words they never granted it. This is no different than Kenny claiming a mythical CT would be started EOY 2016.

Another thing to ponder is... if the EMA was prepared to grant a Phase 3, then why is Kenny messing around with the FDA in the US with a mythical Phase 2b? Why the expense, and time to run a Phase 2b, followed by a Phase 3 in the US, when a Phase 3 can be run immediately in the EU? Or is it because the EMA will no longer grant a P3 based the Lohr studies? Where the EMA in the last 20 yrs has become closely aligned to FDA CT criteria? That would be a tough question for Kenny to answer.

Regardless, foreign studies, without a IND from the FDA, submitted in support of a filing to the FDA, must conform to FDA IND/CT standards.

The Lohr studies do not conform to what the FDA would require.