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Alexza Pharmaceuticals Inc. Message Board

  • atlnsider atlnsider Feb 11, 2013 1:52 PM Flag

    Adasuve Should be Approved in Europe Next Week

    The EMA CHMP will meet next week in London from February 18th through February 21st. Adasuve should receive final approval for all 27 countries in Europe during the week of February 18th.

    Sentiment: Strong Buy

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    • Thanks sawsbaw1 & aa_pippo!

      I am also still very positive on Vivus. Vivus is very close to getting some news from the EMA regarding its appeal of the Qsymia (Qsiva) decision for the EU. As you may remember, the EMA gave Vivus a negative opinion on Qsiva back in October 2012. Vivus did file an appeal of that decision, and the appeal will be decided on by the EMA soon.

      Vivus will probably miss on the earnings numbers for Q4 2012, but Vivus is looking very positive on other measures. Prescription numbers are continuing to grow, and the scripts will grow even stronger after:

      1. The amended Qsymia REMS are approved by the FDA to allow Qsymia scripts to be filled at local neighborhood retail pharmacies instead of through the national mail order pharmacies.

      2. More health insurance companies (payers) agree to cover the cost of Qsymia.

      3. A Stendra commercial partnership deal for the USA market is finalized and signed.

      4. Stendra (Spedra) is approved by the EMA in the first half of 2013.

      Sentiment: Strong Buy

    • Adasuve is officially approved in all 27 EU countries today. The next domino to fall will be a commercial partnership agreement for the USA market.

      Alexza will finalize a commercial partnership agreement for Adasuve within the next few weeks. Should happen in Q1, before March 31st.

      Sentiment: Strong Buy

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