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Sequenom Inc. Message Board

  • dc97531 dc97531 Feb 18, 2013 10:08 AM Flag

    Question on Low Risk Study

    Did the FDA approve this study protocol or did SQNM go out on their own? Will we know the results on December 2013? Oh my.

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    • Sequenom is probably doing this on there own.

      If the FDA approved a study format, you expect Sequenom to mention this. Not just doing this study behind everybody there backs. The only people that know of the study, are people who actively follow Sequenom.

      Sequenom has not mentioned the FDA in the last 7 or 8 months. Normally you expect Sequenom to do some pr: "we are starting with Phase one study, for low risk bla bla bla ...". Think the FDA also has still not figured out what to do with LDT's, and approval processes. FDA is bureaucratic, so do not expect a lot of movement from them.

      Funny thing is, Illumina has actually mentioned more about the FDA, then Sequenom did. Sequenom there answer was: We are talking with the FDA. Illumina: We are looking to get our test FDA approved.

      Who shows more confidence...

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