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jq1234

11/28/13 3:10 AM

#150464 RE: biopharm #150463

I am not missing any point. FDA issued guidance on pCR as endpoint for accelerated approval in neoadjuvant breast cancer first before they approved any drug based on this endpoint. Here is the guidance:

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

Believe whatever you want as I am not interested in having any discussion here. All I tried to do was to tell ex he was wasting time to explain what early look for ph3 actually is as Because I know he has tried many times before.
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md1225

11/28/13 7:28 AM

#150466 RE: biopharm #150463

I mention AA after phase I here, actually as you know Peregrine has more than enough data to get approval now!

http://seekingalpha.com/article/1852541-the-race-for-a-cure-for-cancer?source=yahoo

Happy Thanksgiving to all!