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mike_dotcom

10/25/21 3:44 PM

#333738 RE: GD #333737

This stock is pathetic.

nidan7500

10/25/21 3:50 PM

#333739 RE: GD #333737

GD Agree, AVXL and FDA are waiting the PDD OLE data to finish and sign off the PDD PIII's SAP, IMO.



That was my understanding also.

frrol

10/25/21 4:01 PM

#333740 RE: GD #333737

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.