Ann: Emyria Pursuing Registration of EMD-003 in CY2021, page-17

it doesn't disregard the need to clinical trials but finding out what works via RWD sure is better than expensive trials and error. (see GW pharma) it reduces clinical trial risk by a lot!.

Also, the FDA knows how 'stagnant' clinical trial data is. Its not the 'real world' and they are moving to a more RWD and continuous improvement framework. Trial data + RWD model are important factors for FDA approval no one likes finding out that your clinical trial from back in 1940 has negative effects with a new drug. they just start popping up in your ER departments.