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Re: GD post# 333737

Monday, 10/25/2021 4:01:53 PM

Monday, October 25, 2021 4:01:53 PM

Post# of 462968
The FDA is not "awaiting" PDD data, just the company is. The company will then use it to design the P2/3. That will be submitted to the FDA when it's ready.

And whether it is the old controlled trial data or new OLE data, we don't know. There's a good deal of endpoint data that has not been released, so it's not clear.
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