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
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.
In response to the FDA setback Tuesday, Introgen even lost its biggest sell-side booster. Canacord Adams' analyst Joe Pantginis downgraded the stock to hold from a buy and lowered his price target to $1 from $9.50.
New Drug Applications that are incomplete become the subject of a formal "refuse-to-file" action. In such cases, the applicant receives a letter detailing the decision and the deficiencies that form its basis. This decision must be forwarded within 60 calendar days after the NDA is initially received by the FDA's Center for Drug Evaluation and Research.
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