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2 - We are getting a new indication that was based solely on a very small open-label study with a subjective endpoint. The study was not mentioned at all in the PM, however, it was published.
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We may consider allowing the use of the published, open-label study if they could prove to us that it was the basis of approval. To do this they would have to forward a copy of the S/NDS and any other pertinent correspondence from Health Canada. We could approach Health Canada on their behalf to resolve any contentious issues regarding the acceptability in advertising of their claims related to this study.
