Excellent post ledenfrog.

I'm assuming that the science porters know this full well and I hope they will weigh in on the context this provides for rvx-208 at it's current stage of approvals for phase lll BETonMACE. We know EU is approved and moving through further stages. My guess, and it is nothing but a guess, is that with the 2 patents approved for rvx-208 and rvx-208 + Crestor(rosuvastatin) in China plus completion of the Hepalink deal mean that there is an extremely high probability of a phase lll BETonMACE trial approval for China and possibly the other regions.

We know that based on 210 day trials that rvx-208 has an extremely high safety profile and this seems to be a critical factor in moving to phase lll approvals.

We also know, based on Don's statements on June 30th that RVX is still in active discussions with the FDA re phase lll BETonMACE trial approvals and an orphan trial as well.

BioMedTracker - "but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday."

We know that rvx-208 is an epigenetic drug and it appears that the FDA is favouring biotech drugs over traditional chemical drugs.

However, rvx-208 failed to reach the primary end target of PAV regression of 0.8% in the ASSURE trial as it attained 0.6% regression with a p = 0.08.

rvx-208 did achieve other very important targets such as increased ApoA-l (functional HDL) at a highly statistically significant level (p <0.001). However, it appears that the FDA is favouring end health benefits as opposed to various markers as stated below.

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BioMedTracker Article by Bill Berkrot - "as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels."

Well, BETonMACE is about the reduction of major cardiovascular events and that addresses the FDA's concerns specifically and directly. In the combined ASSURE/SUSTAIN trials we all know that the relative risk reduction of MACE events was 55% in the total sample and 77% RRR in patients with diabetes mellitus, CVD and low HDL. These results were statistically significant. We know that rvx-208 works in combination with Crestor and that RVX hold the patents.

led, thanks for the post.

I look forward to anyone challenging my perspective. I get more pumped about rvx-208 every day.

Good luck to the RVX team in getting the FDA approval but if it doesn't happen all is not lost because rvx-208 already has approval to phase lll with 24% of the worlds GDP and a high probability of approval in another 13.4% of the worlds GDP in China.

GLTA and DYODD.

Thangs are looking great!

Cheers

Toinv :)