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indialong

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indialong

Re: None

Tuesday, 11/19/2019 12:56:56 PM

Tuesday, November 19, 2019 12:56:56 PM

Post# of 425966
Health Canada decision due 11/29, correct?

On April 29, 2019, Amarin reported that the application had been submitted to health Canada and had been granted priority review status:
https://investor.amarincorp.com/news-releases/news-release-details/new-drug-submission-filed-vascepar-health-canada

Priority review status in Canada targets a decision in 215 calendar days: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html#a1.5

215 calendar days from April 29th is November 29th.

Of course, the application could have been submitted before April 29, 2019, that's just the day they told us it had been submitted.
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