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DewDiligence

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DewDiligence

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Re: jq1234 post# 120024

Sunday, 05/15/2011 2:23:05 PM

Sunday, May 15, 2011 2:23:05 PM

Post# of 257250
The BioCentury FoB article gets to the crux of the issue: Should a company develop an FoB, where the clinical program can be somewhat abbreviated and FDA approval in one indication may extend to related indications (#msg-58469454)… or should a company develop a regular biologic (via the BLA pathway), and thereby avoid disclosing IP to competitors?

If an applicant expects to achieve interchangeability, the FoB pathway is clearly preferable; however, if interchangeability is out of the question, the answer to the above question is not easily determined.

“The notion that there’s a Chinese Wall between sell-side analysts
and investment bankers may be the second-biggest piece of BS
ever promulgated in any area of human knowledge!”

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