>With data from the Phase II studies conducted by LEO in Europe, how much additional work will the FDA require of GTC(+partner) in the US?<
In my opinion, the next step in the DIC program in the U.S. will depend more on how much risk the company and its partner-to-be want to assume than on what the FDA mandates. It would be a high-risk decision to embark on a large and expensive phase-3 program based only on Leo’s trial, so I think a U.S. phase-2 trial in DIC is fairly likely.
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