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Navidea Biopharmaceuticals, Inc Message Board

  • ontopofitall4u ontopofitall4u Mar 16, 2013 8:53 PM Flag

    How long will it be before European approval?

    It is much harder to get US approval. Maybe they will get approval in Europe for all cancers including head and neck. Then, after applying it in Europe, the US will expand the use here.

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    • Per CC, they said within the next 1-2 months...

      • 1 Reply to zippyicon
      • I don't know ZIP if you are a pumper or innocent long, But as I said in my comments it is over a year away. Partnership may be few months (1-2 or early) BUT NOT EMA. Here is the conversation in the Navidea Biopharmaceuticals's CEO Hosts Lymphoseek FDA Approval Conference

        Congratulations, guys. Just a couple of questions here. As the lady before me just brought up, what is the review cycle, the timeframe for the application? And the next question was, can you shed any light on what was the exact issue of CRL with the third-party manufacturer?
        Mark Jerome Pykett - Chief Executive Officer, President and Director

        Sure, Brian. The review cycle for the EMA tends to be similar to that for the FDA in terms of its length. It tends to be between 10 and 12 months of full review. That said, the European regulators provide specific dates for feedback at various times, at which point, depending upon the scope of the responses required from the sponsor, they can "stop the clock," meaning they'll stop their review while information is prepared and supplied back to them. So it's difficult to predict the exact timing. Sort of the inside window would be between 10 and 12 months after filing an acceptance of the MAA by the EMA. With respect to the issue about the CRL, we have sort of moved beyond that. As we said, going back to the time the CRL came out, that we felt confident we could reply and respond to the agency. We've done that. We did that within 7 weeks. That was very successful. We had a quick turnaround for us. And we're very happy with our position with our manufacturers at this point. So I think we'll move on from that.

    • over a year per CC. So, the shorts will be relaxing and enjoying their victory and laughing on us longs.This stock is a shame.

      • 1 Reply to fincheck100
      • They submitted in Dec and EMA accepted in Jan.and EMA has a 12 month review process. However, on well performing drugs and good data, they tend to move more quickly vs US FDA. So I tend to believe late Q3 or in Q4 but worst case in Q1 of 2014. But a good chance for early EMA approval, IMO. Also, they applied for GLM (General Lymphatic Mapping) and I think the EMA will approve it as GLM unlike the FDA. All IMO

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