Biotech-Stock Mailbag: Amgen, MiddleBrook

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Stephen P. brings up one of my favorite topics:

"Do the FDA and European filings by Introgen Therapeutics (INGN Quote) change your negative outlook for the company, even just a little bit?"

No.

I'll be magnanimous in congratulating Introgen for meeting its most recent, self-imposed June 30 deadline to file an approval application for its gene-therapy head and neck cancer drug Advexin with regulators here and in Europe.

Of course, Introgen promised this filing four years ago, but heck, meeting real deadlines is so 2004.

Unfortunately for Introgen, the Advexin clinical data package is now in the hands of independent and meticulous drug reviewers who will not be swayed by misleading press releases and a management team more interested in touting Advexin to ensure their next paychecks than actually developing a real cancer drug.

The U.S. Food and Drug Administration and its European counterparts will find all the flaws in the Advexin data -- and will quickly come to the conclusion that Advexin does not work as advertised by Introgen. That's clear from the phase III data presented publicly. In particular, I can't wait for the post-hoc, subset p53 biomarker analysis to be shot down. That's the real crux of Introgen's bamboozlement all these years; an FDA filing is merely the beginning of the end.

Look for an FDA rejection in one of two ways -- either a refuse-to-file letter at the end of August (60 days after this week's filing) or an approvable letter at the end of December, telling Introgen that Advexin cannot be approved without additional clinical trials.