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longfellow95

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longfellow95

Re: beachhyena post# 197612

Thursday, 11/15/2018 6:42:13 PM

Thursday, November 15, 2018 6:42:13 PM

Post# of 700957
It's free gratis for us.There is a waiver on the BLA fee of $2.2m if you have Orphan Drug Status.
And there is also a small company/small revenue waiver.



Just as well really...

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079298.pdf
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