It will be hard for Ed to get an approval now. A CEO just wrote to me saying this: "I think it would be fair to say US government is a bit in disarray right now. Seems hard to believe dysfunction goes all the way down to reviewers but then they say anyone who can get out at all levels is getting out and we all know the good ones leave first. I heard a commentator say yesterday The White House cannot mount an effective program about impeachment as everyone there is from the “C” team. For sure FDA is having trouble replacing people who leave. Nothing we can do but focus on Europe and Canada for now."
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