Highwayman, If you understand how Orbis would be applied, I have a couple questions.
How important was MHRA certification to an Orbis project?
Is it strange that Cognate (US and Canada), Advent (UK) and Franhouffer (Germany) all be mentioned in a recent 10Q about manufacturing?
It sounds like FDA leads the collaborative project, is that accurate?
Would SAP submission be coordinated and approval from all four expected or can there be more than one SAP?
Does SAP approval in two jurisdictions indicate likely approval by all 4?
How long does Orbis take once the applications are complete?
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