bfw ... business person in the medical field, light on science here. The FDA meeting occurred on 11/13, can we safely assume tthat these types of discussion would occur in that meeting? For example, this works great and has benefit NOW, along with a safety profile, to advance NOW with an indication for cardio patients with diabetes and certain eGFR and/or alkaline phosphate levels ... while it is further studied for additional indications, utilization, and patient benefits?
Not looking for definitive answers of course, just wondering about typical FDA follow up meettings to studies, in situations oike ours, where there is some GOOD data, but still a lot of questions? ... and additional 21% RRR is good, given the safety profile right?