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Fly News Breaks for September 12, 2018
PTLA
Sep 12, 2018 | 09:24 EDT
Portola Pharmaceuticals last night announced that the FDA assigned a PDUFA date of December 31, 2018, for the recently submitted prior approval supplement for the generation 2 manufacturing process of Andexxa, equating to a four-month review period, William Blair analyst Matt Phipps tells investors in a research note. Portola management had conservatively guided to a six-month review, the analyst notes. He's encouraged by this review timeline, pointing out that approval in 2018 would provide Portola with full commercial supply for Q1 of 2019. Phipps remains confident in the potential of Andexxa to achieve blockbuster sales and believes Andexxa alone is worth "significantly more than the company at current price levels." He keeps an Outperform rating on Portola Pharmaceuticals.
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