thanks for pointing this out - I didn't know the FDA...

thanks for pointing this out - I didn't know the FDA can't introduce new concerns over and above the original 6 questions!

This makes me feel a bit better.

The sense I get is that that the FDA acts in part like a research mentor - and wants to know that their ideas are taken seriously onboard. After reading the conf summary by Mozz, I have a feeling Donna is on target with her comments to address FDAs concerns. I feels on the addressable side, notwithstanding a cost in terms of time and with extra time comes extra money.

But manageable.

I take onboard the missed timelines - extra 6 mths on P3 commencement - but overall it feels like it's moving. We're sitting in a traffic jam - but at least the queue is moving!