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marzan

10/22/19 7:13 AM

#248553 RE: HappyLibrarian #248551

FDA and Europe regulator work in mutual understanding. Europe doesn't move a finger until FDA acts. This is what happening in most of the drug approvals if you can go back and look. US is where all the money is in this industry. You win FDA approval and you are going to be huge by GIA or b/o.

longfellow95

10/22/19 8:42 AM

#248565 RE: HappyLibrarian #248551

It is strange that Ms. Powers is seemingly putting all her eggs in the FDA basket and yet put NWBO through the expense and regulatory red tape of conducting parts of the trial in both the US and Europe.



Why do you think that?
What about Advent and Sawston (with its jumbo new NWBO sign), and the recent office address in Amsterdam (necessary for EMA application)?
There is nothing to indicate all eggs are in the FDA basket.
Earlier movement in Europe than in the US wouldn't surprise me.