Introgen's 'Promise'

On Dec. 22, 2005, the company announced that it had asked the FDA for permission to "accelerate the initiation of an interim analysis of its randomized, controlled phase III Advexin clinical trial data ahead of schedule."

The FDA agreed, said Introgen. The plan called for data from the analysis to be submitted to the FDA to "advance Advexin's regulatory submissions," said Introgen's Talbot in the release.

But what happened to Introgen's earlier request, in December 2004, asking the FDA to accept a "rolling BLA" for Advexin? Twelve months had passed -- surely the FDA must have responded, no?

It's a mystery, because Introgen was mum on the subject.

On March 14, 2006, Introgen held a conference call to discuss its fourth-quarter 2005 results and discuss in greater detail this new "agreement" with the FDA to analyze data from its phase III trials. But during the Q&A session, one caller was more interested in learning when Advexin would finally be filed with the FDA.

"The first question I have is when are you going to file the last section of the BLA for Advexin," asked the caller.

Introgen CEO Nance replied:

"Max [Talbot], you can comment if you want to. It will be brief, I'm sure, but we're not giving particular guidance. As you know, a BLA is completely filed when all sections are in. We are providing data to the agency sequentially. We have pending requests for accelerated approval. We have a confirmatory trial strategy that is coming into place that Max described to you with our interim efficacy analysis on phase III. I don't think there is an answer that we can give you for that particular question."