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Fly News Breaks for June 18, 2018
VRX
Jun 18, 2018 | 09:38 EDT
Valeant Pharmaceuticals today reported that it received a Complete Response Letter from the FDA on one of its key pipeline products, Duobrii, Wells Fargo analyst David Maris tells investors in a research note. Additional data, if required by the FDA, may take six months or more to develop, Maris contends. He suspects Duobii is no longer a 2018 launch, as Valeant had previously guided, and believes it may not even be a 2019 event. Maris views this as a "major setback" for the company, noting that Duobrii is part of Valeant's self-titled ''Significant Seven'' products that the company hoped to get to $1B in peak sales over the next four and a half years. When added to the "disappointing" launch of Siliq, Valeant may need to update its expectation for the ''Significant Seven'' peak sales, Maris states. He has an Underperform rating on the shares.
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