hi @Babba within a couple of hours simon had left a message with...

hi @Babba

within a couple of hours simon had left a message with my work reception (had my work email footer on the email)...

i called him back on his mobile and he answered first time..

was very good with his time and i appreciated it... even once done he prompted me for more questions if i had any etc.

contact will be made/initiated once 12 month data is back (this quarter)... but, perhaps the perception for some (including i) was that it's much easier to lock FDA down in a room than what it really is... PAR will get the 12 month data, initiate contact with FDA, to which it can take a set period of time before getting replies/feedback/calendar commitment from FDA etc...

my take on it was that PR was being realistic of when a conclusion/meaningful understanding would be reached on discussions, rather than the initiation process... realistically, i dont think there was ever going to be a decision result until we have dosing results back in q1 anyway.