I understand that, but nothing should take this much information to validate. The problem with the regulators is that if decades ago something was done this way it still should be today.
If it were up to me, the DSMB's would tell the regulators that results of a trial were looking pretty good. At that point the regulators would travel to clinical sites and have a look for themselves. If the results looked good, they'd approve after a commercial production facility was approved for the manufacture of product. Years and tens of millions, or more, could be removed from the process.
Gary
Bullish
Market Data 
Markets 
AI
