JMP Securities analyst Liisa Bayko noted that the FDA has told Aimmune that it will not begin the review of the BLA for AR101 due to the government shutdown, but also because AR101 is an allergenic product. Beyond the shutdown impact, this action by the FDA, or lack thereof, highlights that AR101 may be exempt from PDUFA, meaning there is no firm commitment to items such as Priority Review, Bayko said. Given this new level of uncertainty, she has pushed back her U.S. launch projection for AR101 to 2020 from late 2019, but since she has also pushed back concurrent launch expenses the delay has no material impact on her valuation, Bayko stated. She keeps an Outperform rating and $40 price target on Aimmune shares.