Sunday, September 15, 2019 8:44:26 PM
Cognate prepared for the pre-approval inspection. They do not conduct the inspection, regulators do. We do not know if that's been done, but it is possible it has (It typically takes seven days), because Cognate is already talking about their past pre-approval inspection preparation. Although, typically complete BLA filed first before inspection....who knows with rolling BLA.
Here is an image I found on the process (not specific to Cognate).
Note: Cognate already reached GMP approval for Europe as well by June of this year.
I'd assume we are at least as far as that last star to the bottom right in the process.
https://www.contractpharma.com/issues/2018-06-01/view_features/pai-readiness---a-journey-not-an-event/
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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