Bernard, I sold every last share of INGN this week..from gleaning the INGN boards both at Yahoo and IVillage, it appears a lot of the retailors and shorts are using this CC as a binary event of sorts..Fuerstein put out another epistle today..
I will never be an apologist for an exec team from whom I don't get the ALL the information that they have..notwithstanding, I truly don't believe that their delays in guidance are about them running a scam..the FDA has has been leaderless in the last 6 years but for a tiny period under McClellan, Padzur is borderline hostile, gene therapy trials have been unpopular since 1999, Gendicine was approved in 2003..I believe that these phenomena have had an impact..
By Adam Feuerstein
Senior Writer
3/7/2007 12:03 PM EST
thestreet.com.
Introgen Therapeutics (INGN) has accused me of being "false and misleading" because of some sharply worded columns in which I detail the ways the company has misled investors about its development of the cancer gene therapy Advexin.
So far, Introgen hasn't detailed how I've been false and misleading, and the company has never contacted me or asked TheStreet.com for a correction. But on Thursday, Introgen will hold a conference call to discuss its fourth-quarter results. On that call, the company has promised to comment further.
Good. It should be a fun call. To get ready for it, I read through transcripts of Introgen conference calls going back four years. Below is a timeline of sorts, complete with excerpts that detail the many ways in which the Advexin story has changed over the years.
Investors would be well-served to acquaint themselves with this timeline before Introgen management speaks again on Thursday.
Here's Max Talbot, Introgen's regulatory chief, speaking on the company's second-quarter 2003 conference call on Aug. 12, 2003:
"As discussed in previous calls, it is our plan to file the BLA for Advexin and head and neck cancer in 2004."
Then, David Nance, Introgen's president and CEO, speaking on the company's fourth quarter 2003 conference call, held Feb. 27, 2004:
"We are moving closer to our goal of filing a BLA -- Biologic License Application -- for Advexin later this year."
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." .......
......On Aug. 9, 2005, Introgen held a conference call to discuss its second-quarter 2005 financial results. It had been 12 months since the company said Advexin's "submission review process will take approximately one year." Perhaps Advexin was finally in the hands of the FDA?
Unfortunately, no, explained Introgen's Talbot:
"We are in ongoing contact with the U.S. Food and Drug Administration and are continuing to implement the regulatory plan that we described at the time of our biologic license application -- BLA -- request to the agency in December 2004."
Right. In December 2004, Introgen had asked the FDA if it could submit a "rolling BLA" for Advexin. Eight months later, had the FDA said yes to Introgen's request? |
