Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-516

Too much focus around the vehicle (45 US vs 26 AUS). The BID 5% arm was also a huge problem, 26%  (US) vs 43% (AU).
They have eliminated the individuals being an issue by going over that data and the clinicians and now turn to manufacturing as a root cause of it.

Couple of problems with this hypothesis -

1 - blame the US guys for being new. The Aus guys who did the 1b's were new at the time and there wasnt an issue with what they produced.

2 - Permetrex and CBD produced at different sites in the US.

3 - The manufacturing is hitting 2 arms (3 if you count vehicle as 2.5 and 5 separate), across 11 batches, while giving normal data for 2.5 & 5 once a day treatments.

Hopefully they start moving onto looking at macro factors such as the one suggested here -
https://hotcopper.com.au/threads/lo...-by-accident.5028180/page-16?post_id=41034242
"Actually, it looks like a classic data block transposition error - surprisingly easy to do when graphing data extracted from a larger database. The original data will confirm or deny the possibility, assuming the raw data files haven't been mislaid!"

They will keep looking for it, even though it may appear that an excuse has been made and they are moving on.

Phase 3
FDA concern is safety to get there - Met easily. No adverse effects.
Aus data on its own is significant enough to be commercial, hence the confidence to move forward. The bugbear is the no statistical significance when you combine the US vehicle - which is obviously an anomaly.