Biotech Values

[dewophile]

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