NEU neuren pharmaceuticals limited

Ann: Neuren receives response to request for Breakthrough Therapy, page-36

  1. 7,264 Posts.
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    Contacted the company earlier today, and Dr Treagus returned my call after he finished in a meeting.
    With the application to the FDA, NEU don't get to sit in front of a panel to present their case, they send their documents off to the FDA who then decided ya or nah, in this case it was the latter and NEU received a 1 page response with not much information!!
    @ajostu, you have basically nailed it on the head, historically the FDA needs lots of data and lots of trial patients hence no approval. Dr Treagus was not to surprised by the response (from my reading between the lines) but they will be progressing under the fast track designation that has already been approved. He also went on to say they were looking forward to meeting with the FDA.
    cheers
    sediment back from a hold to a buy for me again
    Last edited by fooca: 02/03/15
 
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