Ann: AGM Presentation, page-5

Didn't get that impression on PTX100 - excellent safety, excellent progress of trial, initiation of expansion cohort, sweet spot for unmet need and shortest path to market? Those statements all imply a bullish upside, although the throwaway line that FDA guidelines seem to be changing might have been worth more explanation .... was that the reason you perceive a lack of confidence?

All I know about the FDA is when you get there, make sure you tick all the boxes especially the ones about efficacy vs effectives (actually proving it was your product and not some other intervention that produced the desired results) and then reproductability (that you can manufacture the exact same product that led to the efficacy and effectiveness in the first place).

I think PTX has this covered and the Chairman's address touched on it as well particularly around commercial derisking in manufacturing.