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entdoc

01/08/12 12:19 AM

#73698 RE: freethemice #73697

freethemice, nice.thanks. question remains whether FDA is shifting toward CLINCAL significance (quality of life,etc) in addition to squeaking by with statistical significance.

Fire Fox

01/08/12 1:41 PM

#73716 RE: freethemice #73697

Thanks FTM. Your slide brings to mind the importance of SK's remark at the AGM and in CC that Mgmt is very excited by the way in which the data in all clinical trials is proving to be consistent across the board with data from the animal studies. Thus there is every reason to believe that combining Bavi with Sorafenib is having a similar effect in the current liver clinical trial as what is shown in your graph.

My favorite context for day dreaming on this point (i.e. the consistency between clinical and preclinical Bavi results) is the Company's flagship, blinded, 2nd-line NSCLC trial. Several separate preclinical studies showed that a new dose of chemo upregulates PS on a resistant, 2nd-line tumor just the same as it does on a front-line tumor.

If this preclinical fact holds true in the current 2nd-line NSCLC registration trial, it should not be hard to beat the 6% to 9% ORR that docetaxel (i.e. the SOC for drug resistant NSCLC tumors) achieves in a 2nd-line setting. 9% is a pretty low ORR threshold to have to beat if the engine driving Bavi's performance, i.e. exposed PS, is exposed (i.e. upregulated) the same in the 2nd line setting as in front line setting where Bavi's ORR beat front-line SOC results by 50%. See Dec 6 PR.

I believe this is the essence of why Mgmt is so optimistic about upcoming trial results.