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Genomic Health Inc. Message Board

  • bsinghvt bsinghvt Feb 23, 2006 9:33 AM Flag

    Alright GHDX board

    In for the long haul, company has great potential.

    Any thoughts on the FDA inquiry?

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • The FDA inquiry is not going to have an impact. Here are the two possible scenarios:

      1) FDA does nothing because regulating home brew testing would cause a significant problem across all molecular labs incluing Quest and LabCorp. Remember, in the world of moelcular testing, the vast majority of tests are homebrews performed in CLIA high complexity labs. To regulate Genomic Health would be to try to regulate all CLIA labs...not likely.

      2) The FDA decides to regulate even against their better judgement. NO problem...the data I have seen and knowing the history of their CSO, I would be wiling to bet that they could generate all of the design control docs needed to file an application for approval with the FDA. Their biggest effort would be in the area of gaining GMP status on the facility and quality system through the appropriate FDA inspection/certification.

      Bottom line, they will be okay either way. The reality is the FDA isn't even going to touch this one because of the issues I stated in point 1.

      • 1 Reply to mdxpert1
      • Seems to me that the big money that moved the stock up is still here.

        Some small retail investors paniced on the news and sold it down and now it it consolidating.

        I'm of the opinion that this company will do great things for many, many years and is a great opportunity to accumulate weakness and build a position for the long term.

        All IMHO.

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