Riz, just realizing now I sent this via PM, meant for a public response as to add to discussion...

I agree mostly with what you’re saying about the FDAs role. But CFRs are not laws, they are guidances. I wouldn’t say you’re wrong, that the FDA steers companies, but more so they provide recommendations, companies can go against recommendations (and do) as long as they present compelling information in their case. Obviously bigger companies have more weight (and track record) to throw around. Moreover the FDA telling CYDY to leave Samsung (a world class CMO, that presented no problems in the BLA) to start manufacturing in the US doesn’t make any sense on many levels