Patients need to be dosed for at least 6 months (see AHA poster). Although it seemed full enrollment was announced in March 2018 (see here), DM stated at the Sept 2018 AGM that China continued enrolling until sometime in June 2018. So based on that latest info, last enrolled patient was in June and that last enrolled patient has already cleared the minimum 6 months.

You also stated "I just don't get how they could be so far off their original date for initial primary end point data. This is just my opinon and why I beleive they are saying H1." 

We are 9 days into 2019, which is 9 days beyond their previous guidance that end of dosing was expected by end of 2018. It's going to take longer than 9 days to make me worried.

As for US patients, I'm pretty sure that even though North American sites were approved, no clinical sites were ever opened and no US patients were enrolled. Anyone else have info to confirm or refute this?

As for announcing MACE event total updates, that is uncommon. See here.

BDAZ