We've had confirmation from Sarah that the decision to do, or to not do, an SSRA....that decision does not rest with the company. 

However could it be that the FDA has determined that the trial, as currently constituted, is sufficient?  That is to say that it is "poperly powered"  and that there will be no need to boost the number of patients?  In that PR it says this:

The statistical analysis plan and endpoints proposed by the Company were reviewed and accepted by the Division of Cardiovascular and Renal Products (“DcaRP”) of the FDA. 

It seems to me that, included with the stastical analysis plan, that its reasonable to think that there's recognition by the FDA of the fact that BETonMACE is sufficiently powered at ~2,400 patients...If the FDA believed more patients would be required would they have given it an endorsement?