They appear to have changed the specifics of the trial fairly...

They appear to have changed the specifics of the trial fairly significantly. They are now appearing to be looking at pain reduction, function improvement and DMOAD in the P3 trial. Patient monitoring to 405d and decrease in patient numbers are very significantly different to previously announced.
So I'm curious as to whether these changes have already been negotiated with the FDA or whether PAR have submitted all these trial changes in hope and the FDA are going to chop it around significantly. I would hope that it is not the latter, because it would be very irresponsible to be publishing these changes if they are completely unrealistic or haven't been negotiated with the FDA.