NEU 0.35% $19.97 neuren pharmaceuticals limited

7 Days till lift off ! Or earlier ? FDA announcement prediction, nearest to the pin, hour and date AEST ?, page-33

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    It will be hard to tell given we most likely wont be privy to the issues identified in the CRL letter. Grounds behind issuing a CRL may include labelling issues, current Good Manufacturing Practice concerns or concerns about the safety or effectiveness of the drug (per Wikipedia)
    If safety or effectiveness are listed then thats an almost certain death knell. The other issues could certainly be tweaked and the application re-submitted.

 
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