PTLA didn't say the FDA had actually agreed to a single-trial p<0.01 criterion for approval. (There is no SPA.) Typical biotech-investing scenario where you have to parse management's comments closely.
PTLA red flag: Management wants to amend the SAP for the phase-3 APEX study of Betrixaban, despite the fact that the trial is 50% enrolled. Sounds like they don’t think the trial will hit the primary endpoint on the total population and are already trying to make an argument for subset data. (Source: Today's 2Q14 CC.)
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