I think it may be a semantic issue - the difference between the week of the study (starting from first dose) and the post-last-dose week.
HEPLISAV approval on the first review as fait accompli?
Nothing is ever a fait accompli with the FDA - there can always be manufacturing concerns, for example. But efficacy here is crystal clear, and I really don't see any safety concerns based on what they have disclosed to date. Two cases of new-onset hypothyroidism and one mild vitiligo case in some 2,000 people (age 40-70) over a year isn't any sort of signal in my view - that's just background noise.
I would expect them to be munched prior to launch. This product fits right into the sweet spot for several big pharma, and their other stuff is pretty early.
I think it's still attractive at these levels. The only cautionary note is they filed a shelf offering, and I would expect them to pull the trigger on that unless a potential partner/muncher is hot on the trail.
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