ODAC's recommendation to FDA that a sequencing test (diagnostic...

ODAC's recommendation to FDA that a sequencing test (diagnostic test) be validated in order to identify patients with the specific T315I mutation and who thus stand to benefit from Omacetaxine therapy is logical and should not be surprising at all. As someone experienced in dealing with the FDA, I am surprised that anyone (CXS management and informed investors) is surprised at this recommendation from ODAC!

By way of example, Merck's Erbitux (cetuximab) - an epidermal growth factor receptor (EGFR) antagonist for advanced colorectal cancer - is only effective in the treatment of patients with the K-RAS wild-type genotype. It is not effective for those patients with the K-RAS mutant genotype.

While FDA did not limit the approval of Erbitux to those patients with K-RAS wild-type genotype, medical oncologists only prescribe Erbitux for these patients. If Erbitux was undergoing FDA approval today, rather than 5 years ago, then ODAC would almost certainly require a validated diagnostic test in order to identify those K-RAS wild-type patients who stood to benefit from Erbitux therapy.

I have stated in the past that FDA "want to approve" Omapro. This is still the case. Part of FDA's remit is to protect the American public from harm from foods and drugs. This remit extends to being able to identify those patients who do not stand to benefit from a particular therapy. The meed to do this relates to the morbidity on the patient from the treatment itself. All treatments have side effects. If there is no efficacy from the treatment then there is harm potentially being done without therapeutic benefit.

April 9 is an important date. I do not believe Ompapro will experience any significant delay from approval and when approved, that approval will be more robust. I believe ODAC's recommendation to FDA yesterday was a blessing in disguise.