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Trius Therapeutics, AŞ Message Board

  • bioimmunomabman bioimmunomabman Mar 7, 2013 11:28 AM Flag

    Question about registration strategy

    I see the second phase III trial used an IV formulation while the first phase III was oral. If successful in the second phase III trial, will they be able to file in one, either, or both, or will they determine the best formulation/administration oral vs. IV and do another trial. What's the strategy and timing? How large is this first market? Thanks, I just recently learned about TSRX, but have been investing in biotech for 20+ years. I am not an expert in antibiotic administration.

    From the company web site: In December 2012, Trius announced that it completed enrollment of its second ABSSSI trial, ESTABLISH 2. This second pivotal Phase 3 trial was designed to evaluate the efficacy and safety of tedizolid and linezolid when initially administered as an intravenous (IV) infusion with the option to switch to oral therapy. Trius expects to report top-line results from the ESTABLISH 2 study around the end of the first quarter of this year.

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    • This trial would allow them to treat a patient in the hospital with the IV and switch them to oral for a total of 6 days therapy. This saves healthcare dollars by allowing the patient to leave the hospital much sooner. The 1st trial was only IV. You can read the recent seeking alpha articles to get more on potential sales. It would be substantial sales for TSRX at the current market cap.

      Sentiment: Strong Buy

      • 1 Reply to siamesekitty711
      • Thanks again. The SA article was how I learned about this, trying to do some DD before deciding on a purchase. I was not sure if that rev figure was just for the total market is approved for additional indications, or just the initial market. IV to oral makes sense for lowering cost, if the oral works as well as the IV. Lowering the hospital stay from 10 to 6 days is also a huge savings. Now the decision about when and how to play, stock, or options, or some combination.