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Quote: That's the fault of the FDA who failed Relenza and...

  1. 830 Posts.
    Quote: That's the fault of the FDA who failed Relenza and patients by not accepting proposals for clinical trials using Relenza as an IV delivery...

    Port, do you have any reference to the facts that support your claims FDA refused proposals for trials?

    In this Biota document:

    http://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=00433501

    Page 4; BTA said: Quote:
    - GSK restricted Relenza to its proprietary Diskhaler system, and did not adequately pursue alternative or improved inhalation system.

    - GSK withdrew support for crucial post-approval clinical studies designed to expand the product’s use and market acceptance.


    Any objective reader would know who is the culprit from the above BTA document.

    This is fast becoming a FDA bashing site so as to make GSK looks good even to the extend of claiming FDA refused Relenza approval and delayed the approval to one year after Tamiflu.

 
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