I look online and all I get is info about cervix and uterus.. I assumed something to do with the position of the uterus but then when I looked online it had things like "left Adnexae visable" so I then decided it was ovaries??????? adnexa, annexa (accessory or adjoining anatomical parts or appendages to an organ (especially of the embryo)) "Fallopian tubes and ovaries are adnexa of the uterus" So it is just as you'd guessed.
, a biotechnology company focused on the development of medicines to treat thrombosis and other hematologic disorders, tumbled as much as 10% during Tuesday's trading session.
Therefore, if it were to gain approval, it's possible that a European launch would occur before a U. The Annexa-4 study also demonstrated positive results that would seem to indicate approval is eventually in the cards.Of the 47 patients tested in the efficacy population, 37 were shown to have had excellent or good hemostasis 12 hours after the Andex Xa infusion.In short, there remains a clear path to success for Portola, even with this minor hiccup.Keep your share-price appreciation expectations a bit modest considering that the company has yet to prove it can successfully grow its portfolio post-launch, but there's no reason to hit the exit based on the Dec. The company recently submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process, which constitutes an amendment to the submission.Therefore, the agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company on labeling and post-marketing commitments.In correspondence dated and issued today, the FDA communicated that the action date will move from February 3, 2018 to May 4, 2018.Portola is developing Andex Xa as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery.The BLA seeks initial approval of Andex Xa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding. treated with oral Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding. Andexanet alfa is also under review by the European Commission of the European Medicines Agency (EMA).Major bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding and bleeding into other critical organs) in patients taking Factor Xa inhibitor anticoagulants has become a significant cause of hospital admissions, morbidity and patient mortality. Including patients taking the injectable Factor Xa inhibitor enoxaparin, it is estimated that more than 150,000 U. A final decision by the European Commission on the marketing authorization application (MAA) for andexanet alfa is anticipated in the first half of 2018.About Andex Xa Andex Xa is a recombinant protein specifically designed to bind to Factor Xa inhibitors and rapidly reverse their anticoagulant effect.