Agree … and, any kind of competent review of FDA performance over the past 20 years or so would certainly bring up massive questions on competencies.
The FDA has a lot of splaining to do around AD performance. Over the last 10+ yrs. most have begun to show acceptance in US for Quality and Regulatory systems in other countries like Australia any Scandinavia/German or selected Asian other choices also fit. Dr.M. is taking some kind of political backlash risk but considering the status of CNS diseases WW and the value of precision medicine processes it's all good. IMO, the Sweden PD call is also big.
The scientific process will certainly generate more question than answers in the near term about how to deal with the inevitable political/regulatory fallout from new facts as they be known. IMO, the FDA has no one to blame but themselves. I have confidence they will do a good turnaround and get back in the race. DR. G. seems like a competent leader although he has a lot of OH to get rid of. But, any expectation that the rest of the world was going to just wait while the FDA retooled was wrong, IMO.
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