Introgen's 'Promise'

Jumping again to December 2006: It was the end of another year without Introgen finishing the job of filing Advexin to the FDA. In fact, it wasn't even clear whether the company had started anything. And we still didn't know if the FDA ever responded to Introgen's request -- now two years earlier -- to file a rolling BLA for Advexin.

After talking again on Dec. 28, 2006, about analyzing the phase III trials of Advexin (which, by the way, began in 2000 and have never completed patient enrollment), CEO Nance was asked for a rough timeline.

"To respond to your question, the phase III analysis will begin early in 2007," answered Nance. "Before the end of the year, we expect for all of the analysis and filings to be complete. Max Talbot can elaborate on that. But in terms of the timing, we know when we'll begin the process, and we're not providing any specific guidance on when we will conclude specific parts of the process."

Talbot did elaborate:

"We believe that corroboration of our phase III results with these prospective Phase III analyses will support Advexin licensure in the U.S., either via the accelerated or full approval regulatory procedures. We look forward to providing you with additional updates as we complete our U.S. and European regulatory filings in 2007."

That sounds like a promise -- an Advexin approval filing in 2007. Will Introgen make this deadline? Perhaps we'll find out on Thursday afternoon. Let's hope the company does better than it did in 2004, 2005 and 2006.