DNAprint Genomics (DNAG)

[Hopeful107]

From the Khandaker report: Nov 4 2005

Ovanome - Phase 2 - PMA 2Q06 - Launch 2006

Statnome - Phase 2 - PMA 2Q07 - Lunch 2008

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Wall Street Analyst Forum 2005 Analyst Conference -
November 30, 2005 :
Ovanome - Phase 2 - Services Market 2007 - no market date for kit. - Guess 2010
Statnome - Phase 1 - Services Market 2006 - Kit market 2009
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The Dutton Report: For Ovanome and Statnome
We believe the development of Ovanome is relatively Stagnant. We had anticipated the product would enter clinical trials in 2004 and should take between six and nine months to complete. We believe the data generated by the trials is intended to form the basis of a 510 {k} application for the monitoring of cancer patients. Additionally we are unsure of Dnaprint's state of READINESS to conduct and completean effective clinical trials. The company recently announced it will commence a study of the ovanome Predictive assay using ovarian cancer patients samples to be procured by the H. Lee Moffitt Center-affiliated Bay area Oncology of Tampa ,Florida. However, we do not believe Dnaprint has revealed even the highlights of a clinical Trials design,and has had no Preparatory MEETING with the FDA and has not enlisted the help of a clinical research Organization {CRO}. We also believe less than half the planned enrollment of the 250 patients has been completed. Additionally we have concerns surrounding the strategy of Submitting the product for approval under the 510 {k} application to obtain approval for commercialization under the 510 {k} application. There must be a Predicate Product on whichto base the submission and we know of no Predicate product. The FDA could therefore REQUIRE dnaprint to conduct a Full Clinical trials with a large enough patient base to be powered statistically.

All better read - Dutton shots down the Ovanome and Statnome test by Dnap. !!!! This is very bad. Over and out.

Dutton Report - Complete Update:

http://www.jmdutton.com/research/DNAP/Reports/DNAP_Report_061705.pdf

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From the 10QSB filing date 1-3-2005 page 11 the Summary

We will continue work on OvanomeTM, a Taxol screening diagnostic test, currently under development that could be available for physician use in late 2006 or early 2007 along with our continued efforts on other research and development projects that are underway.

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Part 1 Page 18 from the 10KSB file date 4-15-2003

Within the pharmacogenomics market, the Company has already developed and expects to soon market a chemo-predictive test, OVANOME, for the drug Taxol, one of the most commonly used chemotherapeutic agents for cancer. OVANOME is a genomic-based diagnostic tool used to predict the likelihood of response of ovarian cancer patients to therapy with Taxol. We expect to complete clinical trials of this product in 2004, but various factors including profitability from forensics testing and the procurement of investment could accelerate this schedule. An application for market approval, if required, will be submitted to the FDA later in 2004, and DNAPrint believes final approval could be received as early as the first quarter of 2005. We are in the latter stages of negotiation with a pharmaceutical company interested in the OVANOME test, though the Company may choose to market the test on its own to maximize shareholder benefit. The Company's test would give one generic manufacturer a competitive advantage over another in the eyes of payors. DNAPrint expects this will be a trend that defines the market for chemo predictive tests until the dominant pharmaceutical companies embrace them as integral to their business of not merely developing, but marketing new drugs
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From the Ovanome Executive Summary:
The clinical trial for OVANOME will be finished in early 2004 An application for approval to market, if required, will be submitted to the FDA by mid-2004 and approval obtained by early 2005. DNAP has a patent pending for compositions and methods relating to OVANOME. Sales of the OVANOME products to labs in 2005 will result in income of $4 million. This product launch will create a new, emerging US market of over $16 million. OVANOME is forecast to reach a peak-year sales record of $12 million in year three and hold steady for several years as the classifier test of choice in this market niche.

Does any of this make sence.