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Re: staticmirror79 post# 531

Thursday, 11/01/2018 6:56:32 PM

Thursday, November 01, 2018 6:56:32 PM

Post# of 5639
You just said what I said in my original post, but with more words. That’s basically the definition of pedantic.

The PR is clear, they’re still talking. The FDA could ask for more data, or thy could expedite the approval process. The PR says both options are still on the table.

This article talks about various pathways available and how some of them don’t even consider long and expensive Phase 3 trials:

https://www.biosimilardevelopment.com/doc/how-the-regulatory-pathway-shapes-biosimilar-business-decisions-0001
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