Genta submitted the trial design to the FDA in December 2005 and then revised its proposal in July 2006 in order to address issues identified by the FDA. However, the company said that it is still waiting for the FDA’s comments on the revised proposal.
“We remain committed to bringing this important product to patients as quickly as possible, while we continue to explore the breadth of its clinical potential,” said Dr Raymond Warrell, chairman and chief executive officer of Genta.
Genta also recently announced its financial results for the second quarter of 2006. The company reported a net loss of $14.6 million compared to net income of $1.9 million for the second quarter of 2005.
The decline in revenue was largely due to the termination of the collaborative agreement to commercialize Genasense that had been in place between Genta and Sanofi-Aventis.