Ok, I'll try to have a summary of what we learnt:They have had a...

Ok, I'll try to have a summary of what we learnt:

• They have had a rejection, not a "please provide more information" request.
• They haven't yet received feedback (or surely there would be a Trading Halt)
• They allowed a leading question to be asked about sample size (according to the 12th July announcement, n=88), but did not answer it
• No other meaningful responses to other questions (e.g. Why no TH, can/will you submit to another HREC, timelines)

I am very surprised that there is not feedback/comments from the HREC. In every application I have made (not medical, but to other HRECs), you get feedback at the time of decision. Otherwise all the HREC creates for themselves is a need to provide timelines for feedback. To have not been told today about timelines, or feedback is suspicious.

88 participants for a Phase 1 trial is BIG. Phase 1 is usually "is this safe / does it have side effects?", with small numbers, whereas Phase 2 is "does this work?" and requires larger samples for statistical power. This Phase 1 trial seems to be related to safety, but also dosing information (it included randomised amounts of "dosing escalation").

They already have a Clinical Trial in progress I believe (30th June 2022), with 30 volunteers, to explore mechanism of action. This will also provide safety data. Pure speculation at this point, but I see the most likely reason is that the HREC wanted to see the results from the existing trial before letting further participants have EmtinB - why risk the safety of new participants when the exisiting approved Clinical trial will get this data? Then, once safety is established, a further Phase 1 trial will be needed to check safety at the different levels of dosing proposed.