Thanks...it will be very very interesting to see what the FDA has to say.
Whatever the answer, though, I'm not sure "closure" is the right word. Yes, they are finally getting real data published and safety review of this, perhaps what you specifically mean, but at the same time, should this get approved, in some ways this will be introducing another difficult question for individual cardiologists and their patients: where do you draw the best line of demarcation of stroke risk versus bleed risk? Is total # of all events the absolute best case or should more weight be given to reducing stroke events, for instance, in comparison to bleeds?
I'm probably jumping too deep into the topic already for this particular thread, but did at least want to point out for those that follow the link above that only the 50% (approximate) reduction in bleed events is mentioned in this press release. What is
not mentioned is the increase in stroke events as a result. So, for additional info, a much more involved discussion on this took place here:
http://www.valvereplacement.org/forums/showthread.php?40196-On-X-Life-Technologies-Releases-Expected-Timelines-for-Reduced-Anticoagulation-Study and in another thread embedded in that one.
In any case, obviously questions such as these will be exactly what the FDA will be discussing, and I will certainly be very curious about their analysis. Hopefully, it may even follow the pattern of drug approvals in recent years in which the evidence packet and FDA risk/benefit analysis will be fully available online, but since it is only a modification to the Instructions for Use, though, perhaps not.
By the way, while on the topic of PROACT, that other thread I linked to mentioned that the interim results for the low risk group (plavix and aspirin only - no warfarin) should be coming out by end of the year as well...
