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Re: iryokabu post# 338553

Wednesday, 05/05/2021 8:10:21 AM

Wednesday, May 05, 2021 8:10:21 AM

Post# of 430192
It may not be needed to get approval but perhaps required post approval. I just don't see the FDA saying no on a positive outcome, conducted by the VA against a disease with so few options. Then again, if we don't resolve the patent problems I don't see them adding it to the US label. The ROW will benefit from additional indications.
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