A bit more on the FDA, page-64

"If the statistician conducted such a review and gave notice to MSB / TEVA - this would have to be reported to ASX / Nasdaq . No such notice was ever given to ASX / Nasdaq."

Been very busy today, and I missed this bit from Anjo-Roch, which I think makes an important point.

Now under continuous disclosure rules, covered in chapter 3 of the ASX listing rules, if MSB "becomes aware of any information concerning it that a reasonable person would expect to have a material effect on the price or value of the entities securities, the entity must immediately tell ASX that information"

Clearly we both think that a failure to meet the surrogate endpoints in the CHF trial would qualify under this rule. However MSB could make one or more of the following arguments in favour of their non-disclosure:

a) as a surrogate endpoint it wasn't material​

b) by disclosing that Teva had walked and disclosing the development contract, it had effectively already disclosed the failure​

c) MSB was relying on one of the listing rule carve outs - perhaps the FDA required them not to release the surrogate endpoint failure to maintain the integrity of the trial, or that the information was a trade secret.​

​

Unless MSB were banned by the FDA from releasing the information, then not releasing it was highly dubious in either case. However the fact that a couple of months before the interim analysis was performed, Silviu said

SI: we have a first interim analysis that is going to read out towards the end of this quarter beginning of the second quarter and that's roughly on the first 120 patients that have been followed for about six months looking at surrogates of the primary event surrogates being systolic and diastolic volume and as I said we we saw very very dramatic effects in the Phase II trial. So if we see a similar directionality in the first interim then I think will be very pleased in terms of the administrative look.​

..​

Jason Kolbert: so what I hear you saying is that the first interim analysis now actually can move a little bit beyond just safety when you know I think that safety is going to be okay but but now we're actually going to get a read on efficacy through a surrogate marker like end-systolic volume​

​

SI: that's correct"​

Seems to suggest that had the data been positive, MSB might not have been as reticent to release it.

Others have suggested that the development agreement was amended to allow Teva to walk for other reasons, however that is not possible because of US listing rules that require material contracts and amendments to material contracts to be released. No such amendment was produced, therefore the contract could not have had a material change. source

At the risk of being repetitive (!) this STILL therefore leads inevitably to the conclusion that the surrogate endpoints weren't met.