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Fly News Breaks for July 15, 2016
VRX
Jul 15, 2016 | 13:09 EDT
After the FDA released briefing documents ahead of Tuesday's Advisory Committee meeting to review Valeant's brodalumab, Wells Fargo analyst David Maris said he sees "significant approvability risk" for the drug. The FDA is recommending a new study monitoring psychiatric symptoms be completed prior to brodalumab's potential approval given the suicidal ideation experienced by patients in the trial and Maris believes Valeant will abandon the program if required to conduct an additional study. Even if approved, physician use of the drug would be limited, contends Maris, who keeps an Underperform rating on Valeant shares.
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