Replies to post #150453 on Avid Bioservices Inc (CDMO)

[biopharm]

jq1234, here is some more info that may change your mind regarding the use of blood samples which will be allowing the FDA to make approvals and Roche just had a drug approved based on this very method - of blood samples. Times are changing for the better.
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Roche’s new timesaving formulation of Herceptin approved in Europe for the treatment of HER2-positive breast cancer

Sept 2, 2013

approval was based on data from the HannaH study which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy (pathological complete response, pCR)

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94379512&txt2find=fda|blood|samples

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More info re: Pcr - See lines 290-311 ... page 7

Pcr - Pathological Complete Response will be determined by indication... this just shows the area for breast cancer and soon-- NSCLC, just in time for "SunRise"

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf

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Whats more interesting are the latest FDA trial protocol changes that would allow these "blood samples" being taken during such a Phase III "SunRise" NSCLC trial ..... to be sort of, watched mighty closely : )

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