Introgen's 'Promise'
Stock quotes in this article:
INGN
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."- Loading Comments...
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