"I find that amazing that we would have to do a phase 2 for CKD even if we have positive results on the subgroup data of BETonMACE for CKD. If we have the funds why would they not allow us to do a phase 3 right away, especially considering the safety profile of Apabetalone. The same for the subgroup of C,... if good results why not phase 3 for next trial...?"

No doubt in my mind that Resverlogix wants to cast as wide as an umbrella as possible......eventually. However, this is a progressive endeavor. Trial priorities and plans evolve over time. Furthermore, what the company wants to do isn't always in line with what the regulators (i.e. FDA, EMA) want to be done. Let's wait and see what happens with BETonMACE first and the rest will fall into place in due time. There are always follow up trials with successful drugs. Apabetalone will be no different, assuming BETonMACE succeeds. 

In my opinion, it makes sense to be able to go straight to Phase 3 in Stage 3 CKD patients for imnproving renal function if the BETonMACE CKD sub-study proves that apabetalone is safe in these ~250 Stage 3 CKD patients and effective at improving eGFR and lowering alkaline phosphatase. However, keep in mind that BETonMACE patients are also low-HDL, diabetic, recent ACS. If Resverlogix wants to expand to those with Stage 3 CKD but not necessarily low-HDL and/or diabetic and/or recent ACS, then they may need to start in a pre-Phase 3 stage. Similarly, for trial(s) involving Stage 4/5 dialysis/end stage renal disease patients (that weren't part of BETonMACE), they will need to definitely start in pre-Phase 3 to establish safety first. 

One thing I noticed today's BIO-Europe slide deck (also in earlier 2019 presentations too upon checking), is that in slide 28 towards the end describes the proposed Phase 2 CKD trial as "Patients with low baseline eGFR evaluated for improvement in renal function vs. placebo." Previously in the Nov 2018 Bio-Europe slides, this trial was described as Phase 2a BETonRENAL "Evaluate the safety, tolerability, and efficacy in Dialysis Patients." No presentation has listed both Phase 2 kidney/renal trials. Perhaps they are now looking to for their next kidney/renal trial to be with the Stage 3 CKD patients like in BETonMACE and are de-prioritizing the Stage 4/5 CKD dialysis/end stage renal disease trial?

BearDownAZ