TanamiRod,
Good post...I suspect 600 is on the optimistic side but I concur it's not impossible...). I also suspect that based on observed data, n will also be revised down at least somewhat from what the last protocol for 002 Stage 2 and 003 was. I tried to ask this at the AGM as my one and only question based on data from 008 and Donna came back saying that there is some scope for revision down. (perhaps not as much as I would like of course)!
We also have to factor in potentially some monitoring that the FDA may still insist on due to increased dose compared to Stage 1 002. Monitoring will add a good degree of expense but if it is required I'm hoping it will be removed at some point past a safety review during P3.
Cheers
Mozz
where are we at at the moment ?, page-32
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