Things really do seem a little different at the FDA
these days. The FDA's commissioner, Scott Gottlieb, has talked openly of
wanting the agency to take a different approach to its interactions
with the biopharma industry, speeding up processes, removing certain
roadblocks, and generally shifting more toward a "let the market decide"
philosophy. Although there are a lot of moving parts to that, some of
them quite controversial and beyond the scope of this piece, it has had
an immediate impact on H. Lundbeck (OTCPK:HLUYY) (LUN.CO).
Lundbeck
made a surprising announcement late on May 2 that the FDA had chosen to
grant expanded labeling claims for its depression drug Trintellix.
Although this change is not going to make a night-and-day difference for
the company, it is a positive development all the same and one that I
believe could boost Lundbeck's long-term revenue growth rate by close to
1% and its fair value by more than 5%.
Read more here:
Lundbeck Gets An Unexpected Boon From The FDA
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