Biotech Values

[mouton29]

<<Under your interpretation, what questions would there be for the FDA to ask Teva about labeling? If the FDA takes the position that a carve-out for the STEMI indication is warranted according to H-W, wouldn't the FDA be dictating this rather than asking about it? >>

I clearly need to spend more time understanding this, but it seems to me that the sponsor is the one seeking the carve out on the label so as to not infringe the patent. So I could imagine some back and forth over the language of the carve out in the label. Below is a link to the FDA decision denying the Watson's citizen's petition.

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064806a010f