Citi Says Expect FDA PDUFA Decision For Portola Pharma Early

Portola Pharmaceuticals Inc PTLA investors should be marking Friday on their calendars.

Citi analyst Yigal Nochomovitz expects the Food and Drug Administration to release its decision on betrixaban on Friday, earlier than expected, as it has become a precedent for the FDA to release decisions before weekends/holidays.

Betrixaban supposedly reduces the risk of blood clots for patients who leave the hospital after a medical treatment. While Portola’s clinical data has not been great, with the drug failing its Phase 3 clinical trial, Portola has been able to push ahead for an FDA ruling.

Phase III Trial Not As Bad As It Sounds

According to an article on gurufocus, the drug should not be written off after the failed phase III trial, as it only failed in one particular subsection of patients. Specifically, for “patients that have been hospitalized for serious non-surgical conditions such as a heart attack, severe infection, stroke or a host of rheumatic disorders and that are at risk of developing a blood clot because of subsequent immobility.”

In the other two subsections, Betrixaban outperformed in phase III.

Update: Shares were halted at 11:18 a.m. ET. Traders began circulating an FDA document appearing to show FDA approval for Betrixaban.

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