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Endocyte, Inc. Message Board

  • chinesehamsters chinesehamsters Jul 25, 2013 4:17 PM Flag

    Question For Long Time Holders

    I have been going through articles and press releases about Vintafolide and one thing I am not seeing is any mention of this being filed yet for approval in the US. In November of last year I see it was filed with the EMA and was also given orphan drug status. Am I missing something or is there a reason that have not filed for a US approval with this drug?

    Chinese Hamsters

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    • For FDA approval they need OS data in PROC - Which should be available by 1H 2014 or 2H 2014 based on trial extension.

      Sentiment: Strong Buy

      • 1 Reply to sudhanva_n
      • I have been looking over the PRECEDENT trial data that is presented in the ASCO poster. Progression free survival looks very promising, 21.7 weeks vs 11.7 weeks vs PDL alone. Even better in the patient population that was 100% folate receptor positive. Presumably some of these patients are still being tracked?

        I read an opinion in an article that stated that ECYT was moving ahead with the EU filing in spite of the negative OS data? To what data are they referring? Also, in the PRECEDENT trial they refer to the population of patients as ITT. What does that stand for?

        Chinese Hamsters

    • EMA filing is based on sucessful results of Phase II trial of vintafolide.
      EMA allows filing with Phase II data and if all filing requirements are met, it grants a conditional approval (CA), which is then supported with phase III data (when completed) by the applicant to make it a full approval.
      Conditional approval (CA) allows quicker access of a promising drug to the needful patients (for oncology=anticancer drus, CA is very frequent in europe)

      I am not sure about US FDA requirements but ECYT plans to file NDA with phase III data which is due in first half of 2014.

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