golf, tundup, tada, others ... I think there is a decent to good chance we will need to do a concurrent/confirmatory P4 for CVD, and a P3 for CKD (for official indications "labeling") and hopefully accelerated based on data ... we just don't know key data yet for eGFR/CKD other than sick CKD patients respond well within their CVD issues? But what about actual GFR and kidney function SPECIFICALLY? .. that's a big remaining question we all await, March?

However, my hope is for conditional approval for CVD (with concerrent P4?), with some wiggle room for CKD applications/indications (depending on eGFR data?) under CVD global concerns and indications even if the CVD concern is mild or only exists as a preventive possibility given known statistics of associations between the diabetic/CVD/CKD ailments. And, well, if you are a diabetic with CKD then you are also highly likely to develop CVD as well at some point whether it exists now or not. You are also highly likely to develop CVD simply as a diabetic alone. So, we are back to diabetes as the gateway condition (preventive given safety, and future cost savings?), that encompasses both groups of CVD and CKD potentially ... and potentiallly VD as well due to the diabetic effect on vessels overall.

If diabetic CVD patients are granted access to apabetalone as a first indication, then many many diabetic CKD and VD patients will get access as well, almost by definition. 

Diabetes is the root indication that can impact (study-able) statistics further over time with several other disease entities and categories, with safety as the golden key. Diabetic CVD is the "now" documented (via BoM) and the door opener.

I'm out over my ski's a bit, and trying not to ramble, but the key for apabetalone has always been getting the first door open for therapy (CVD?), with diabetes as one (or the primary) of the root issues, which leads and collaterally involves other unmet needs associated with the diabetes itself over time, per statistics.

Active disease management(?), as well as disease prevention(?), given a known root cause for additional statistically known disease associations. And what will we also learn about "inflammation" impact iteself over time as well, related and unrelated specifically to CVD, CKD, VD conditions?

The "safety" element, could provide latitude and "cover" for doctors. And downstream statistics could further provide the necessary confidence for additional labeling, as data collects in a study format? 

In Trump's SOTU message, he very specifically mentioned the efforts with the FDA to get drugs approved faster. And to reduce healthcare costs, and everyone in the states references Canada for lower medical/drugs costs. There are just a lot of things pointing in the right direction statistically, emotionally, strategically ... for a drug with a wonderful SAFETY PROFILE ... which appears to have SIGNIFICANT benefit in certain proven areas, and strongly suspected benefits in other areas?

Since Sep 30, Don/RVX has really picked up momentum with "low key" confidence and discussion about

1) The Science (hold your shares) ... check

2) BT application (they're coming) ... check

3) Clear Path to Commercialization ... kinda closer and heading that way faster now, but not quite yet

4) a Profitable 2020 ... we'll see (I'm thinking yes)

Of course, I humbly and graciously defer to the clinical & science folks here to correct my thinking for these reambling visions and thoughts of the future and path ... I'm just a medical business, marketing and sales type ... and maybe just trying to convence myself hahaha :)