Introgen's 'Promise'

On Introgen's first-quarter 2004 conference call, held May 11, 2004, the Advexin filing story changed. Here's CEO Nance (emphasis added):

"With respect to our lead product Advexin, we remain on track to begin the BLA submission this year."

On the same call, SG Cowen biotech analyst Joshua Schimmer asked:

"As far as when you expect to complete the BLA filing, if you're going to start in '04?"

To which Talbot replied:

"We will initiate the submission this year though. We talked about that for quite a while and we're still on track for that."

On an Aug. 12, 2004, conference call, Talbot tried to offer more clarity on the Advexin filing strategy:

"... We remain on track with the initiation of the submission of our BLA this year. We anticipate completion of the submission review process will take approximately one year."

Fast-forward to the end of 2004: Did Introgen succeed in "initiating" the BLA process for Advexin?

Nope. On Dec. 23, 2004, the company announced instead, via press release, that it had "filed a request with the U.S. Food and Drug Administration to accept a 'rolling Biologics License Application' (rolling BLA) for Advexin."