Temsamany,

I agree with you and I support the RVX position that a 5-yr trial to get apabetalone approved for CKD patients is not the best way forward now.  Although apabetalone does not have a successful phase 3 trial under its belt, it does have well-defined beneficial physiological effects, a very strong safety profile and a very wide range of disease states in which it can be expected to be beneficial (with varying degrees of supporting evidence).  Job one now is to get apabetalone approved for at least some CKD/CVD patients; a great deal of off-label use would quickly follow.  Just as I think Resverlogix made the right choice in turning funding from the government for 'animal trials' in the COVID work, I think it made the right choice in indicating to BP that it wanted a quicker trial timeline for CKD.  They already have a Breakthrough Therapy designation for crying out loud. 

I am satisfied that the shorter trial is being not being designed by RVX alone - it may be that Don presented the 5yr and 2yr time frames to give an idea of the ground that has to be covered in developing a mutually agreeable trial design.  I think the BP partner (that Don indicated he still thinks will be involved) and the FDA will both be completely engaged in trial design and approval.  And yes, the trial is unlikely to be underpowered given the BoM2 outcome.  (I take it that most would have picked up on the question about power asked by Chris Boehringer in the question period.)

Whether RVX goes ahead on its own (with major shareholders) or with BP, significant dilution is the price to be paid.  Much better to partner up with a BP at this point, getting from drug approval into a great manufacturing and distribution system will be easier and faster.  But getting a good deal at this point is going to be tough and RVX can't appear to be desperate.

I also note that Don indicated that the webcast was delayed in order to present some 'new' information - did anyone catch what the new or improved info was? Perhaps there was still something held back that hasn't quite been finalized yet?

Jupe