I guess you wouldn't expect GILD to highlight the relative negatives and the FDA can generate its own interpretation but the relapse and other data suggest GILD may not be as dominant as some suggest and the valuation might be a little bit overdone
probably something similar was said when one patient died after taking AFFY's drug
there is a lot of money in this stock right now so there will be plenty of people telling you that nothing is wrong.
it is probably a good idea to keep an eye on the FDA website to see if there are any label changes or warnings added to the label. When a stock is priced for perfection even a small blemish can cause a substantial drop. Biotechs are rather richly priced at this point already.