Rosetta Genomics (ROSG) - microRNA Message Board

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Biotech / Medical : Rosetta Genomics (ROSG) - microRNA

ROSG 0.430

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May 21 5:00 PM EST

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To: tuck who wrote (41)	1/18/2009 11:34:41 PM
From: rkrw	of 58

FDA wants prospectively defined retrospective data. Identify the genes you want to study up front, collect the samples, then unblind. Getting data published would help sell it to docs. Limited data, not prospectively defined, not published, will have very little chance for taking off. Most of these tests sound great on first blush but won't sell at all. Here's a little snippet from the kras panel: FDA agreed to accept the data under the following conditions: the trials must be adequate and well-controlled; the sample size must be sufficiently large to ensure randomization; tumor tissue must be obtained in more than 95 percent of registered study participants and an evaluable result must be available for greater than 90 percent of study subjects; the assay must be reviewed and validated by the FDA; genetic analyses must be performed according to a qualified assay methods by blinded investigators; and that sponsors and the FDA must create an analytical plan to test hypotheses for updating labels and making promotional claims

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