RE:RE:RE:RE:RE:bearskin skinned again by DM...when will bearskin learn???.PoC,
Let me return the favor of responding to your itemized points.
a) it is not ASSURE II it actually has different end points.
Correct. BETonMACE is based upon the post-hoc analysis of ASSURE and SUSTAIN. No argument there and I never made any representation otherwise.
b) in ASSURE and SUSTAIN the MACE RRR was not a primary endpoint was it and it came up with what 55% and 77% RRR (and i agree with that finding); but in BoM the target very quizzically is only 30% so why the big gap (PS i was in the 6 month camp until i read about the dramatic reduction in RRR target)
30% RRR is still an AMAZING result. AMAZING. Why would they want to shoot themselves in the foot and make the primary endpoint of BETonMACE 55% RRR or greater when 30% RRR is still AMAZING and perfectly acceptable? If they exceed 30%, then great!
c) 208 is not a cancer therapeutic (ie fixed dosing regime x times at x duration in x amount) 208 will be used like statins take 1 or 2 or 10 a day for the rest of your life or many many many years; what is 208 lacking greatly long duration data (what is the longest trial 6 months)...maybe someone knows this more than me but i believe all statins went through multi-year trials to determine their long-term health impact
Look PoC, I'm not the one who wrote the statement that alluded to the trial continuing until at least 250 MACE events have occured. Who was that......oh yeah it was Resverlogix! All I did was offer a potential interpretation with a disclaimer that we need to wait for the final trial announcement/design details to know for sure. Nothing wrong with that to everyone else on this board or Agoracom except for you.
d) so this leads me to believe a) they may likely pace enrollment to ensure that they get long-duration data (IMO if they don't they will be unapprovable) b) the patient population will be sufficiently different in BoM to account for an expected difference or other trials design parameters account for the difference c) the reinclusion of Lipitor suggests somehow the RVX team has failed on something again (i wonder if ASSURE was 12 months would lipitor data have been significant and positive)
Yes, the patient population of BETonMACE is different based upon their post-hoc ASSURE/SUSTAIN identification of low-HDL, diabetic patients being superior responders to RVX-208. In regards to lipitor being included in the BoM trial, I see this as a positive in order to unequivocally show that rosuvastatin has synergistic effects with RVX-208 that are superior to the atorvastatin/RVX-208 combo, or to show that both are effective.
e) leading to my conclusion that in this case i accept DM touting of 2.5 years before data read out, mostly as i believe they need long-duration data and simply don't have it yet
As bfw stated, Phase IV trials are often for long term adverse effects. Or there may be a follow up Phase III with a different patient population to expand the qualifying patient pool beyong just the low-HDL, diabetics. The MACE reduction in low-HDL, diabetic patients may be impressive enough to forego long duration data for this patient population. Like I said above, none of us know this either way until the official trial design is announced.
f) re. july info form; was reinclusion of liptior into the mix mentioned????; as best i can tell this BoM morphs on almost a daily basis (never seen anything like it, tout a trial for over a year by name but have continuous, ongoing and significant design changes)
Yes Lipitor was mentioned in both the MD&A and the Annual Information Form; however they referred to it as atorvastatin. Open the docs and search "atorvastatin" and you will see it. Aside from deciding to include atorvastatin instead of just rosuvastatin, and the necessary increase in patient numbers because of the atorvastatin arm, what else has been a significant design change? Changing on a daily basis? Continuous, ongoing changes? C'mon PoC. Really? If you truly believe this, please provide a list of these changes. I think at one time, they were considering alkaline phosphatase as a primary endpoint, but that was long long ago in the early trial design before moving to MACE. Most importantly, the trial hasn't even been officially announced yet, so how can you be on their back for making refinements to their "proposed" design when its not even an "official" design yet?
g) as DM now touts (that seems to be his primary role) some supposed kiddie trial with a voucher (very bush league to mix voucher and coupon and US with CDN $'s don't ya think) BoM et al won't really matter for some time
I think we're all a little anxious to hear more about the orphan indication and what kind of value this may bring. Also, DM referred to other Resverlogix compounds in his Life Science Report interview that I'm sure we'd all like more clarification about.
h) lastly, i find you quite knowing on science stuff, when you start your pumper rube stick it is kinda funny.
Well, you seem to be the only one to have a problem with my posts. And I have you on ignore so I only respond to your posts when others respond to you or quote you. I can live with that.
BearDownAZ