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DewDiligence

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DewDiligence

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Re: DewDiligence post# 217385

Tuesday, 12/11/2018 9:39:30 AM

Tuesday, December 11, 2018 9:39:30 AM

Post# of 253213
PTLA -7%—CHMP extends review of Ondexxa (proposed EU brand name for Andexxa) to 2/28/19:

https://globenewswire.com/news-release/2018/12/11/1665009/0/en/CHMP-Extends-Review-Period-for-Portola-Pharmaceuticals-Ondexxya-andexanet-alfa.html

The CHMP informed Portola yesterday that it will provide a list of outstanding questions related to the data package the Company submitted for Ondexxya last quarter, which will require additional responses from the Company. The preliminary timetable provided to the Company by the CHMP sets a deadline of January 29, 2019 for responses to the questions followed by a 30-day assessment period for the CHMP to review the Company’s responses.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
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