Koo wrote: "if for example FDA allows BETonMACE trial in US now will that not delay the filing for the European Marketing Authority Approval (MAA) for commercialization of apabetalone in Europe and Asia. As you say US would only be dosed for 12 months if that was the case. Perhaps this is a better strategy to treat US separetly seeing we don't have much of a choice and not delay commercialization of apabetalone outside of North America. I am assuming we don't need a new drug application (NDA) filed in US to allow apabetalone to be commercialized outside of North America."

This whole issue with the FDA/US involvement in BETonMACE has been dragged out, can kicked down the road, for way too long. The trial is 19 months in, probably close to 75% recruited (an educated guess), and still no closure to this FDA/US issue. The trial is close to hitting the 125 event mark and is likely 18 months or less from hitting the 250 event mark. I really wish that Resverlogix would communicate the FDA meeting results and outcomes that they said they would. Instead, we are left guessing. 

Even if US involvement in current BETonMACE was granted, it would take time to get those study sites organized and activated. Therefore, there would likely be only a small number of US patients and the length of dosing would likely be limited to ~12 months before the trial hit its original goal of 2400 patients enrolled and 250 MACE events. My guess is that the FDA wanted a certain number of US patients in the trial and dosed for a similar length of time as the original BETonMACE cohort. In order for that to happen in the current BETonMACE trial, it would have likely had to have been amended to increase the number of total patients and to lengthen the trial to allow US patients to be dosed for an average of 18 months. And if the original BETonMACE trial was amended/extended, then this would have delayed the trial results readout and delayed both the European MAA filing and the US/FDA NDA filing. Again, this is all conjecture.

In the slide we saw yesterday, it appears that the original BETonMACE will remain as is (2400 patients, 250 event target, Europe/Asia/Mexico/Australia study sites) and that US patients will be in a separate BETonMACE (US) trial. As for the original BETonMACE, we still haven't heard official word that Taiwan/China or Russia are enrolling patients despite Resverlogix telling us for a several months that this was starting soon. I believe Austrailia was going to be a contigency plan in case they needed extra patients upon DSMB review later in the trial. 

Hopefully we get some clarity soon....very soon.

BearDownAZ