Rabiez I agree with you. What the FDA wants is a validated...

Rabiez I agree with you. What the FDA wants is a validated diagnostic test that can identify (with sensitivity and specificity, i.e. low false positives and low false negatives) those patients with the specific T315I genetic mutation. As Greg Collier correctly stated on the t-con, such tests already exist, they have been around for years, and they are largely an "off the shelf" tool. The key issue is the validation of the test.

One of the questions on the t-con was whether CXS possessed tissue samples from each of the subjects on their pivotal clinical trial of omacetaxine. This question was asked because one way to validate the diagnostic test is to take a sample of tissue, test it for the T315I genetic mutation, and hopefully be able to correlate: T315I mutation -> response to omacetaxine; no T315I mutation -> no response to omacetaxine. FDA publishes clear guidelines on validation requirements, so CXS should be able to provide the validation data relatively easily and get omacetaxine approved. The safety and efficacy data for the drug is quite compelling and will allow it to be approved. FDA simply want to ensure there is a mechanism in place so that the Oncologist in the clinic can easily identify who stands to benefit from therapy and who does not stand to benefit from therapy. This also is desirable from the Medicare/Medicaid and Private Insurer perspective, as no insurance provider will pay for a drug in a population of patients in which the drug is known not to work.