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Re: At what point does this become a buy?They have said that they will submit prior data as a part of the package they submit, including results from FORWARD I. Feedback from the FDA regarding FORWARD I data was more positive than the street interpreted: in particular, they were given the greenlight to do a single arm trial for registration with accompanying confirmatory trial with both being open label and were allowed to submit data based primarily on investigator assessment (with independent review only for confirmation). |
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