palms are sweaty, page-32

RoyH, Is your information from the company or the FDA docs? Apparently there are some differences between the company version of the FDA communication and the actual FDA communication. Also, the Company's data apparently excluded some data the FDA docs included and the FDA felt it was important enough in drawing to a different recommendation. I'm not a doc or scientist, so I can explain much more than that. I hope the AdCom approves recommendation, but the data discrepancy between the Comany and FDA appears that it could be significant, and the possibility of denial is much higher than previously believed.