QRX 0.00% 2.8¢ qrxpharma ltd

27 Jun 2012FDA issued first CSL"The Company is presently...

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    27 Jun 2012
    FDA issued first CSL
    "The Company is presently considering its response to the requests for additional information with regard to the safety and effectiveness of MOXDUO® and has been granted a meeting with the FDA to clarify the steps required for approval."

    9 Oct 2013
    Meetings with FDA after receiving second CSL
    "The FDA reaffirmed that the safety and efficacy of MOXDUO are not at question, and that the Company’s presentation of the totality of the respiratory safety advantages to an Advisory Committee of experts would help guide their final decision."

    Good thing is this time (second meetings with FDA) confirmed there is NO safety and efficacy issues.

    Additionally, first time we took 8 months to resubmit NDA.
    This time we only take 3 months to resubmit (August 2013 received CSL, November 2013 to resubmit NDA).

    The Managed Funds have been keeping buying QRX shares, didn't sell any shares.
 
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Currently unlisted public company.

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