Introgen's 'Promise'

Introgen never said a word about it.

Moving right along to Introgen's third-quarter 2005 call on Nov. 9, 2005: Once again, the Advexin-FDA story veered onto another course. Talbot announced that Introgen's registration approach for Advexin was now based on using the "'targeted for selective approval' paradigm that is the current focus of FDA's consideration for the evaluation of breakthrough cancer therapies."

Later on the call, Talbot explained: "'Targeted for selective approval' is a registration strategy that utilizes continuing and exhaustive data reviews to determine which patients are most likely to benefit from a new therapy on the basis of molecular mechanisms and other physiological and clinical parameters."

Talbot then referred to an article in the New England Journal of Medicine that discusses at length this new regulatory approach being used by the FDA to review and approve new cancer drugs.

But there was one problem -- the "'targeted for selective approval' paradigm" doesn't exist. In the July 29, 2004, New England Journal of Medicine article referenced by Talbot, authors Dr. Thomas Roberts and Dr. Bruce Chabner are very clear that this new paradigm is their idea, a suggestion to the FDA. The agency hasn't considered it formally, let alone started to use it to approve drugs like Advexin.

By December 2005, the year was almost over, and just like in 2004, Advexin wasn't close to reaching the FDA. With the clock winding down, Introgen shifted gears once again.