I wonder if this suggests a far more willing FDA we are now looking at.  Under President Trump's original FDA Chief Scott Gottlieb, the pressure had been on to approve drugs faster and more easily and the urgency has continued under FDA incumbent Sharpless.  

If the FDA is now bending its own rules, then our drug is a shoo-in for an expedited approval.  All we need to show is statistically significant renal and/or vascular dementia improvements in the sub groups...and who knows...the FDA may approve with a provisio for more data down the line...in conjunction with approval.  

Of course I am assuming that Biogen is being aggressive with its EMERGE and ENGAGE data analysis...which is most likely not the case.