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LakeshoreLeo1953

09/21/23 10:41 AM

#432013 RE: WolfofMia #432005

I have NO clue why you ask that question of what was posted.
The FDA guidance pertains to OLE satisfying the application as confirmatory.
THAT once again is NO ONE's here determination.
The other about revenue was my take on IF AA granted and OLE to form
the basis for Marketing "trial" would enrollment/participation be sufficient given the data
necessary to be deemed REASONABLE. Bottom line I express doubt there will be
any significant revenue to offset a confirmatory trial as you initially proposed.
Let the Australian experience govern expectations.

In either case I am NOT offering my opinion on REASONABLE. Perhaps you should not either?