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longfellow95

11/15/18 6:42 PM

#197710 RE: beachhyena #197612

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

sentiment_stocks

11/15/18 6:49 PM

#197713 RE: beachhyena #197612

I've thought it too.

One can hope anyway. But I've been burned on that flame so many times my fore-finger has blisters.

:)