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dewophile

04/06/11 12:00 PM

#117732 RE: iwfal #117730

i'm not convinced you need SVR data to move to 3 agents - if it becomes clear (and it's starting to) that a 3rd agent is necessary all you need is requisite safety data
that said your timeline is probably more accurate than mine
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DewDiligence

04/06/11 12:51 PM

#117735 RE: iwfal #117730

Elaborating on your point about protocol tweaking, trials with three unapproved drugs in combination will likely need at least five arms: the triple combination, each of the three double combinations (to ensure that each drug in the triple is actually needed), and a control arm.