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Replies to #79585 on Biotech Values
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dewophile

06/16/09 10:23 AM

#79601 RE: DewDiligence #79585

MNTA
all I'm saying is that the request for immunogenicity could also have been related to assessing risk for HIT - which would speak to characterization of the active product. I'm not close to the story - maybe the company alreayd mentioned this was not the case in a cc or whatnot, but when a known SAE of a drug is immune-mediated and there is a request for immunogenicity data, then it's hard to out of hand dismiss the very distinct possibility the FDA has no concerns about it