Introgen's 'Promise'

Elaborating further on a March 14, 2005, conference call, Talbot tried to explain how missing the company's deadline to actually complete an Advexin filing in 2004 -- and also failing to achieve its amended guidance to simply begin the filing process in 2004 -- was, in fact, a good thing:

"Throughout the development of Advexin, we have worked very closely with FDA in an effort to follow the dictates of the agency so that Introgen could consider the most expeditious approach to the registration of this fast track for product.

"It is now our responsibility to take advantage of emerging regulatory and clinical opportunities to speed the introduction of Advexin, and we are doing just that. ... We saw an opportunity to possibly reduce the time of review of the approval process by initiating an accelerating approval registration, primarily on the basis of these phase II findings."

On Aug. 9, 2005, Introgen held a conference call to discuss its second-quarter 2005 financial results. It had been 12 months since the company said Advexin's "submission review process will take approximately one year." Perhaps Advexin was finally in the hands of the FDA?

Unfortunately, no, explained Introgen's Talbot:

"We are in ongoing contact with the U.S. Food and Drug Administration and are continuing to implement the regulatory plan that we described at the time of our biologic license application -- BLA -- request to the agency in December 2004."

Right. In December 2004, Introgen had asked the FDA if it could submit a "rolling BLA" for Advexin. Eight months later, had the FDA said yes to Introgen's request?