Re: Scenario Analysis on end of BETonMACE Phase 3
in response toby
Top-Line Data Expected September 2019 for BETonMACE Phase 3 Cardiovascular Outcomes Trial for Apabetalone
"We are now down to the last few weeks (if not days) to the end of Phase 3. I assume we can get an announcement from RVX any day now. The question is...what then?"
It may just be an announcement that target events have been reached and dosing has ended. This would begin the trial wrap up stage, which could still take somewhere in the range of 2 to 4 months to complete prior to top-line data announcement. See this post for a possible order of events.
"My own hunch is that the company already has an excellent idea of the results. They get patient by patient data. It may be blinded...but there is one key metric that makes the blind go away: the eGFR data of each patient. If the eGFR data for any patient is soaring...well, you can pretty much peg that as a patient getting Apabetalone."
It is pure speculation that Resverlogix is receiving any BETonMACE trial data updates, in my opinion. Even if they are, we do not know the content, frequency, or format of the data. You are making a lot of assumptions in your statement above. In my opinion, if data updates are being provided then there are likely safeguards in place to format the data in a way to prevent any individual data points from being associated with a particular individual and in a way that prevents tracking of an individual's values over time. This would best protect the blinded nature of the data and protect the integrity of the clinical trial. The last thing we want is for this trial to be compromised. One possibility is that Resverlogix receives updates in the format of the basline clinical chemistry table in this AHA 2018 poster. Still blinded......just reporting the blinded population average at certain time points in the trial. None of it tied to an individual patient or treatment group. If the average shifts over time in the direction of benefit, then one (but not the only) explanation is that it is shifting due to apabetalone treatment eliciting a benefit but placebo having no effect or worsening.
"Once the "blind" goes away, well, it should be a fairly easy exercise for RVX to figure out the real RRR calculations. The short question is: does the data so far from this de facto "unblinding" match their expectations from Phase 2 data? As an investor, naturally, I am expecting a clear Yes. The only question in my mind is wthat level of RRR will we get?"
Are you referring to %RRR for MACE reduction? If so, you are assuming that 1) blinded data updates are occuring; and 2) that these blinded data updates allow for a MACE event to be associated with an individual patient. As described above, the format, frequency and content of any potential data updates are unknown. In my opinion, any trial data updates are just a total trial population blinded average with no individual clinical chemistry values and no association between a MACE event and an individual patient. Only once the database lock occurs will the unblinding allow for the MACE %RRR to be determined.