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Trius Therapeutics, AŞ Message Board

  • dharnettsc dharnettsc Jul 10, 2013 7:30 AM Flag

    CC recap

    CC recap
    1. Asian partner Bayer - starting trials in Asia
    2. Tedolizid NDA later second half NDA. 8 month priority review
    3. Mid 2014 PDUFA expected
    4. Broad spectrum gyrase antibiotic in clinic early 2014 (this could meet huge unmet medical need)
    5. EMA filing 1st half 2014
    6. FDA/EMA/China single 700 pt global lung study starts before end of year 2013, site selection underway
    7. Tedolizid phase III study lead article in JAMA 2013
    8. No interaction with MOA's, SSRI's
    9. 6 month safety data pristine, expect final 9 month safety data in next 1-2 months
    10. Stat sig less side effects than Zyvox including less GI, platelet suppression, and optic/sciatic nerve damage
    11. Hired commercial VP - physician/payor/pharmacist surveys predict 29% initial market share based on efficacy/compliance/side effect profile. 92% of infectious disease docs expressed high interest in Ted (8-10) on a scale of 10. I expect ID docs to drive the use of Tedolizid
    12. Announced plans to hire 125 US sales force PRIOR to PDUFA DATE
    13. In Q&A CEO stated "robust discussions" with potential partners and expect to "announce something by the end of the year". The moderator announced the end of the session after that last quote so no follow up given as to whether he was referring to US or European partners
    14. Well capitalized 84 million. Runway Q2 2014

    Have I mentioned that I like this company???!!

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