retro...How about because that was specifically mentioned in the Dutton report earlier this summer? How about because the major holdup, IMO, has been the foot dragging by the FDA in releasing their pharmacogenomics guidance, first expected out by mid-2004, but now known to have been completed over a month ago, and finally expected to be released this month?
Here's the text from Dutton, four separate passages, that I find relevant:
...In making the reduction of deaths by adverse drug reaction a new mandate, the FDA is following a strategy set several years ago and aimed at the reduction of drug adverse reactions from chiral impurities in drugs. On January 31, 2003, the FDA released an initial statement related to pharmacogenomic tests in recognition that pharmacogenomics will enable drug treatments to be tailored to specific patient sub-populations. To facilitate the emergence of pharmacogenomic test and therapeutic drug co-development, the FDA has held a series of workshops to discuss the issues. By mid-2004, the agency is expected to issue a joint guidance statement with the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) outlining a pathway for regulatory approval of pharmaceutical therapy/pharmacogenomic test combinations. Definite regulations governing pharmacogenomics testing could come from the FDA during the 2005/2006 time frame. These guidelines and the likelihood of new regulations will press the pharmaceutical industry to analyze who is responding to a particular drug, and then develop phenotypic markers that are predictive of what will be a patient's personal efficacy profile. DNAPrint genomics is in the forefront of this new diagnostic field, now referred to as pharmacogenomic profile diagnostics. The company sees a substantial opportunity to commercialize pharmacogenomic classification products in partnership with pharmaceutical companies, leading to higher clinical success rates, fewer failed drugs, expanded patent protection and more focused cost-effective marketing..."
And:
...It is our opinion that pharmacogenomic diagnostics, driven by new initiatives currently being explored at the FDA, will play a rapidly increasing role in drug development within the next 2-3 years..."
And:
"OVANOME is one of two pharmacogenomic diagnostic products DNAPrint genomics has in late stage development. Ovanome is expected to be DNAPrint genomics' first pharmacogenomic product for predicting the response profile of cancer patients to treatment..."
And:
The discovery of these novel Taxol-response predictive SNP's has formed the basis of a potential collaborative agreement for the continued development of the OVANOME product...
Nothing concrete, but certainly reason to speculate that perhaps it's time is near. Dutchess isn't purchasing shares at 96% of market to lose money. JMHO
Later,
W2P
AI
