Introgen Critically Hurt by FDA Advexin Snub

Introgen Therapeutics (INGN Quote - Cramer on INGN - Stock Picks) has fallen again -- and this time, the beleaguered drug company isn't likely to get back up.

The Food and Drug Administration refused to accept an approval application from Introgen for its gene therapy cancer drug Advexin, the company announced Tuesday.

Introgen shares plummeted 34.4% to 61 cents in recent trading.

The FDA issues a so-called "refuse to file" letter on the relatively rare occasions when approval applications are deemed deficient or incomplete. Introgen didn't make the details of the FDA's letter public, so the specific problems with the Advexin filing are not known.

Of course, this latest regulatory setback for Introgen is no surprise in these quarters since I've long maintained that Advexin doesn't work. There isn't much need to rehash the myriad ways in which Introgen has misled investors over the years, but if you're relatively new to the story and want to review all the red flags over the years, you can read all about them here and here and here.

European regulators have decided to review Advexin, but that small bit of positive news will not be enough to save Introgen's hide.

The company had $11 million in its coffers as of the end of June, only enough cash to sustain the company until the end of the first quarter of 2009, according to the company's most recent quarterly filing with the Securities and Exchange Commission.

Introgen shares have tumbled 77% this year and are down 83% in the past two years.

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