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10:10
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Originally posted by bedger:
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You are correct. CEO hinted at it. Was of course mocked by the usual detractors who are not paying enough attention to changes going on the FDA. DFU is of course a pressing issue in the US with far too many amputations for a first world country:a year from Diabetes in the US, which is obviously rife. I think an accelerated approval on a phase II trial with a possible phase III confirmatory trial as a condition, a very real possibility.
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This is a phase 1 trial.
(20min delay)