TGA, page-18

Going back to the AGM, Rennie and co reported that they had had received useful guidance on the TGA process.
We all got excited, and looked at the roadmap and came up with a timeline.
EOY 2019 passed, mid-Jan passed, and here we are mid Feb.
What did we miss?
Maybe it is the nocebo effect, or a variant of it, not enough placebo.
I referenced that as follows back in November
https://hotcopper.com.au/posts/41725274/single
"Morgan also queried some aspects of the phase 2 trial:“We view the trial design of the trial (being run in Australia, Europe, and the US) as the key and anticipate a more arduous range of endpoints and compared against standard of care rather than simple saline solution.
It added that while the Phase IIb results appeared to be “broadly positive”, it had concerns " whether the statistical significance between stratum and placebo results were more to do with nocebo effect over outright performance.
A nocebo is the opposite of a placebo — when negative expectations of the patient regarding a treatment cause the treatment to have a more negative effect than it otherwise would have." my italics
I am guessing that the feedback incorporated comment on the nature of the trials conducted to that point. I am guessing here that the patients had negative expectations rather than confirmation of negative expectations in the context of the trial, they were a lot more pleasantly surprised by positive results than maybe with a placebo mixed in.
IF SO TGA may have said, not enough placebo testing to eliminate nocebo being rejected.
So i suggest we need to re-establish just where we are at with TGA...............
Is there more work going on in terms of analysis of results?
Are patients undergoing further evaluation?
Or is the timeline just longer than we thought.
What else?