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Sunday, November 07, 2021 9:33:55 AM
A close friend of mine developed life altering compounds that dramatically improved quality of life, while directing "Central Research" at one of the largest pharma companies in the world. He told me that the BLA. process alone for a 5 year P III clinical trial included tens of thousands of pages of data andtook months to review!! As a matter of fact, when the data was loaded into the vans for transport to the agency, the entire company's team would assemble on the front drive and cheer the drivers as they left the property. What you're describing sounds more like a track meet than a ell managed approval process !!!
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