this is a very long thread so I have read a lot but not ALL...

this is a very long thread so I have read a lot but not ALL posts, apologies,
has anyone mentioned that the timing re ethics approval of Australian sites cannot be 100% engineered for the announcement to be this week, I would not have thought?

the ethics submission would likely have taken place weeks ago, eg at least 4, or longer, and then approval would have come through somewhat randomly. Ethics approvals usually MONTHS!!!!

it might have been expedited as this is clearly an important trial, but ethics committees have a time and due process to follow, so just as we are waiting for the IDMC to meet this week, that is likely pure chance.

AND I reiterate what many have said, no one can know the outcome of the trial, so it cannot be because they know the IDMC is going not not stop, tempting though it is to think that.

so the decision to submit to the eastern seaboard HREC (which is how you get Melbourne and Sydney approved at the same time) must have been taken > a month ago and likely 2 months ago by the company, probably for the reasons mentioned by posters, good for the political, approval (TGA, PBAC data in the country process) - we think there is already EUA in the country although don’t know that for sure.

So I am going with pure chance that it is “so late” that Australian sites are coming on board, so close to the time of the first IDMC review. This often happens that Australian sites come on just as a trial might close.

and yes, if any patients had just come on, and had been randomised to the placebo arm and had not yet received their two doses, and the study was closed for overwhelming efficacy, those patients would be switched to RemL.

all good.
IMO