Yes, as I recall Joe said getting the FDA to commit to SPA would probably make the trial too exhaustive. Better to get results and see if they'll fly. Since he believes the drug is going to work very unambiguously - based on dat and moa so far - he's pretty confident that results will fly. It could be a very smart risk-reward choice. Do a quick, cheap trial and see what you've got. That's a business decision, not a science perfectionist decision. Amd of course it may turn out after the fact to have been a loser. Life's like that - no guarantees.