A bit more on the FDA, page-58

@aaskiet

Your comment re the 4^th reason and TEVA being denied access to the statisticians report is pie in the sky ..who told you that and where is it written.

I can also hypothesize that TEVA did not what to see the Statisticians report (which never occurred IMO ) because they didn’t like the Statistician and his hair was pink.

Regarding your 4^th reason, and the alleged adverse FDA comments and notices raised regardingP3 (to which MSB did not rectify) , based on what’s written – the 4^th is not the reason..
My basis for saying is as follows:

1. Any concern raised by the FDA would need to be reported to ASX/Nasdaq – I’ve seen many such FDA notices issued for other Biotechs.
2. If you read the various AZX releases over the last 3 years , you would appreciate that TEVA lead and championed all the changes to the P3CHF trials from 1700 patients …to 1100 patients to 600 patients (+ confirmatory trials). TEVA was the point of contact with the FDA.

If anything the FDA (via the DMC) have had two reviews of the P3 trials – in April 16 & Oct 16 and have asked the trial proceed as planned.

All the best.