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Posted On: 06/13/2019 12:26:30 PM
Post# of 149074
Based on what the company has said it is the Clinical data and (Chemistry, Manufacturing and Controls (CMC) portions. The non-clinical portion was already submitted. I'm guessing the FDA breaks the submission into these 3 categories.
This likely isn't the level of detail you were looking for, so maybe someone more versed in the process can chime in also.
Here is a website that provides an overview of the BLA submission process.
https://www.thefdagroup.com/thefdgroup-blog/2...a-process/
This likely isn't the level of detail you were looking for, so maybe someone more versed in the process can chime in also.
Here is a website that provides an overview of the BLA submission process.
https://www.thefdagroup.com/thefdgroup-blog/2...a-process/
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Please do your own due diligence. All my posts and comments are not to be considered investment advice.
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