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Keryx Biopharmaceuticals Inc. Message Board

  • biomachine2006 biomachine2006 Sep 4, 2013 4:13 PM Flag

    NDA filing

    Average time for FDA acceptance of NDA/BLA submission for review is ~45 calendar days. Sitting at what...27 days....

    Another ~2-3 wks to go.

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    • Check the FDA website. The FDA has 60 days to accept the nda application for filing. Under PDUFA guidelines, the FDA targets a decision on 90% of a accepted filings within 10 months of application. This suggests that if the nda is approved for filing by Oct 7, we have a 90% likelihood of a decision by June 8,2014. In Japan, the process is not as clearly defined but the vast majority of applications are decided within 13 months of submission. JTTorri filed in the first week of January, so we should hear on that approval and get the next milestone payment sometime between mid December and mid February.

    • You are not a machine, more like a tool, giving out very bad information.
      CHOO! CHOO! hear that?
      Average application review time BEFORE an answer is given is:
      fast track is approx 60 days. (this is ONLY for treatment for a disease/condition that is critical and there is no other drug that is on the market or not as effective) this does not happen often according to the FDA
      Priority process is approx 6 months if certain conditions are met
      Regular processing (where most drugs fall into) is 15 months average. This is all on the website, just search "FDA NDA approval process time)

      Sentiment: Hold

    • We bake the cookies and eat them all while still warm and gooey, then the masses come looking for cookies because of the delicious aroma, but there will be no more to eat. Just pay attention to the stock price, that's how you know the results are in. Be the baker, not the STD on a college condom nipple

      Sentiment: Strong Buy

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