CUV 3.00% $21.63 clinuvel pharmaceuticals limited

++ fda/ ind/ update ++

  1. 22,691 Posts.

    http://www.fda.gov/cder/about/smallbiz/faq.htm#When%20can%20I%20start%20clinical%20trials?

    Extract:

    "When will I be assigned an IND number?

    An IND number will be assigned after the IND application is received by FDA..

    When can I start clinical trials?

    Unless you are contacted, you may begin trials thirty days after FDA receives your IND application"

    +++++++++++++++++++++++++++++++++

    EPT met the FDA for pre-IND application discussions on Oct. 10:
    " The meeting was a “pre-IND discussion meeting” requested by the company for the purpose of reviewing EpiTan’s proposal to submit a formal Investigational New Drug (“IND”) application.

    An IND application must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans and, accordingly, is a prerequisite to starting (human) clinical trials".

    Today, EPT said that they are waiting on the minutes of the meeting with FDA on Oct. 10.

    Gerry


 
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