We may never know how/why the wheels came off this 2017 plan. I guess I should be grateful I am not in some clinic somewhere (or a loved one) waiting for these guys (FDA/all others) to get their act straightened out. When the FDA gets it's processes/conventions/rules and systems lined up and validated so that humans are not sitting in a room voting on the truth.
If M witnessed this FDA cluster knowing/thinking he had strong evidence of effective treatments but could not get them evaluated he must have been really pissed. Going for EU trials instead of standing in the endless queue was a guts call.
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