Seelos Therapeutics Inc (SEEL)

[Bryce Harper]

And when they have talked about upcoming launches before they sold ex-U.S. rights, the countries they mentioned did not include Canada.

Can Mylan even launch with a 7 day shelf life presentation without first successfully petitioning Health Canada for changes in the label and instructions so Mylan can add in a 7 day shelf life outside the fridge? Before or after its sale of ex-U.S. rights, Apricus has not announced any such Health Canada label change or any anticipated time frame for such a Health Canada label change.

This all relates to whether the FDA will decide that it can take longer than 6 months to evaluate Apricus' resubmissison since it is seeking changes that go beyond curing the listed deficiencies.