"Data may very well be so robust in CKD and / or Cognition that the CV readout no longer dictates the success of BOM.
I believe Skipping the SSRA and delaying any additional CKD Trial that could provide additional backstop for the Company speaks for itself.
My guess is it is CKD most likely giving this signal. If the average of the entire subgroup with CKD is showing blinded average improvements in ALP and [eGFR] that would be terrific news.
Each of the markers are FDA approvable endpoints as far as I know, and CKD is a degenerative disease with clear disease markers. This CKD subgroup could be large enough and of sufficient duration for FDA consideration.
I think that these actions of both Management and Board point to certain BOM success, otherwise everything has been bet on CV data which I dont believe the owners of the majority of shareholders including Hepalink would ever do. I believe the Compay knows something and this is the only thing that could be truly knowable at this point, and be counted on ???
It may be Cognition also showing robust average improvements, however FDA approvable markers are far less clear than for CKD.
This is all pure speculation on my part and not investment advice."