Yeah, agreed, lots of info still undisclosed, and CVOT could/should/would be the quickest path commercially still ("potentially") ... and an accelerator for funding and possibly fast-tracking the other opportunities.
Without FLD, it's all guess work. But if I am RVX I am turning the FLD every which way but loose looking for an impressive and loud groundswell of medical/scientific community support at the fall conferences, and a reasoned cogent argument for NOW on an NDA. Well, duh :)