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biopharm

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biopharm

Re: md1225 post# 170538

Sunday, 03/30/2014 9:49:28 AM

Sunday, March 30, 2014 9:49:28 AM

Post# of 347009
I thought I was done for the day till I see 22 months for the Bavi arm : ) If that is the case.... I think everyone should realize that "BLA" approvals need to be backed by data and that data "does not" have to be an official clinical trial that completed. That "BLA" supported data can be pre-clinical and any and all data to support BLA approval. Additionally, that data does not need to be made public by the FDA.... my oh my, a win-win for the FDA and Peregrine and all of humanity, animals and plant like creatures : )

http://www.troutmansanders.com/files/FileControl/c38042c0-a860-4179-8a50-12c1170d84fd/7483b893-e478-44a4-8fed-f49aa917d8cf/Presentation/File/Biologic%20License%20Application%20Checklist.pdf

I can only hope

"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!

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