...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: Is Apabetalone maybe a bad thing for the Pharma industry?

Tada, nice response. 

Led, atherosclerosis, renal disease, diabetes and the myriad of inflammatory diseases are chronic conditions that have many contributing risk factors. These types of diseases, unlike communicable diseases, will never be cured. At best, we hope that lifestyle changes, pharmaceutical interventions, and other medical (and potentially genetic) interventions can lessen the burden of these diseases.

Based on the data we've seen, apabetalone beneficially effects a lot of risk factors/physiological variables that contribute to the aforementioned diseases. However, there are many other risk factors/physiological variable/genetic predispositions that are known (or currently unknown) that apabetalone does not effect. There will always be room for new therapeutics to improve upon current ones, whether this be an improved drug with the same mechanism of action/effected endpoints, or a novel drug that has a different mechanism of action or hits different endpoints/physiological variables. Apabetalone has the potential to be great for patients (and investors), but talk of curing diseases is unrealistic.

Now for Koo, who wrote: "do we really know what critical and important information a " Sample Size Recalculation Analysis"  (SSRA) would bring about that would make RVX a success, keeping in mind (as we're told) that the primary endpoint readout won't be known until the end of 2018?"

If the SSRA has a futility analysis compenent to it, then passing the SSRA is huge. That won't guarantee success, but it would definitely boost the confidence. Keep in mind that there has been no interim analysis of the data yet. Only DSMB reports so far, which are not interim data analyses. So passing the first interim analysis is big in my book. It may even be a catalyst for more things to come, IMO.

Also, as things stand pre-SSRA, the trial is anticipated to conclude at the end of 2018 with the target 250 MACE events achieved. However, the SSRA will determine if the trial needs to add additional endpoint events, and hence more patients. In other words, the SSRA will determine whether more patients (and target MACE events), more money, and more time (and patience) will be required. So the end of 2018 is the anticipated trial end right now, but the results of the SSRA might delay the end. Therefore, the SSRA is quite important to either confirm Resverlogix's previous time estimates, or lead to a revision. I think a lot of investors would find that information quite important in their decision making.

All just my opinion. DYODD.

BearDownAZ

Share
New Message
Please login to post a reply