aab-001 Phase III program Schedule:
It just occurred to me that a revision is in order (I was edittng my post when the 15 minutes allowed ran out, so below is a revised version of the previous post).
The reason is that there is an extra rate-limiting step - the fact that the non-carrier trials will have multiple arms - which makes me suspect that they will dose each arm successively, for safety reasons.
So in the end I am almost back to your (edit = masterlongevity's) dates - although this is not at all clear, as I suspect the lowest dose may be the one the primary endpoint is based upon, and if so it may not effect any delay at all.
AAB001- estimate 15 months enrollment + 18 month duration= 33m
==> Sept 2010 for final data
estimate interim after 9 months = Dec 2009
There is no guidance on enrollment, but I expect it will be far faster than you suggest. Unfortunately there are 2 limiting-steps - the parallel EU trials - plus the fact that the non-carrier trials will have multiple arms (which makes me suspect that they will dose successively).
One thing that I believe I know is because the "symptomatic" endopoint is usually measured at 6 months, then I would expect that is when the interim look might be.
Therefore I would expect:
aab001 - NA trials (by Elan)
=> estimate 4 months enrollment + 18 month duration = 22m
=> Oct 2009 for final data (if they open the data-box)
=> but add 6 extra months for the non-carrier trials due to assumed successive dosing = Apr 2010
=> estimate interim @ 6 months = Oct 2008 (but awaits EU)
aab001 - EU trials (by Wyeth)
=> estimate start Feb '08
=> estimate 6 months enrollment + 18 month duration = 24m
=> Feb 2010 for final data
=> but add 6 extra months for the non-carrier trials due to assumed successive dosing = Aug 2010
=> estimate interim after 6 months = Feb 2009
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