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Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-32

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  1. 2,904 Posts.
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    Here you go Whytee- you really do try and stick the knife into Si don't you? Clearly you have misquoted him. Can you just stop it?

    Edward Tenthoff: Great. Thank you guys, and thanks for the detail on the presentation. So my friend Mike, was wondering what still has to be done for the ahead of the NDA? Are there any remaining pieces that need to be filed or any interactions with the FDA or at this point, are we really just waiting for this to do today? Thanks.

    Silviu Itescu: Well, having completed the manufacturing inspection which was the biggest item still outstanding, we continue to interact with FDA on a variety of questions that backwards and forwards in regard to the review. But other than that, really the major item that remains outstanding is a discussion around the specifics of the label. And that’s really – that still remains ahead of us and we’re very excited as we proceed towards the PDUFA date.



    Reg (Guardian of the Truth)
 
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