Dendreon, The FDA And A False Alarm
15 CommentsBy Ed Silverman // March 3rd, 2010 // 8:18 am
After the ruckus over the FDA advisory meeting for the Provenge prostate cancer vaccine in 2007, there was little expectation that yet another panel would be convened, especially after favorable data was released last year. But Favus Institutional Research issued a report yesterday saying it spoke with some docs, who claimed to be invited to such a meeting, according to TheStreet.com.
The news sent Dendreon stock down about 5 percent and set off a scramble to ascertain the truth. An FDA spokeswoman later said a panel isn’t planned, and a Dendreon spokeswoman said there was no indication from the agency a meeting was scheduled. Deutsche Bank analyst Mark Schoenebaum noted companies must be informed of a planned panel 55 business days before a PDUFA date. The Provenge PDUFA date is May 1. Flavus, meanwhile, stood by his investor note, according to Bloomberg News.
Thanks to Provenge, Dendreon has been at the center of considerable controversy. Angry cancer patients protested outside FDA headquarters and some joined investors in filing a lawsuit against the agency for overriding a panel’s initial recommendation three years ago (see here). And the SEC’s Office of Inspector General is probing investor complaints “alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug,” which sources say refers to Provenge (see here).
By day’s end, Dendreon shares not only recovered lost ground, but closed up about 2 percent, leading posters on investor message boards to wonder whether short sellers were behind the report, given the history and more recent events. Was there a leak? Was this market manipulation? Or just the usual churning over a drug stock? What do you think?
Should the SEC invesigate the report on an FDA panel meeting?
- Yes (97%, 274 Votes)
- No (3%, 8 Votes)
Total Voters: 282
Loading ...
stevierayjon
You need to update the placeholder…
but closed up xx
I think it closed up appx 2.3%
Seeks The Truth
Time and time again, efforts are made to manipulate Dendreon stock, with dire consequences for the shareholders who are victims of the fraud.
Yet, the SEC stands by and continues to look the other way. Oh, did you know that Mary Shapiro’s husband works for a BIG hedge fund in NY?? Puh-leeze don’t EVER try to convince me that is no “conflict-of-interest” here.
But previous SEC chairpersons have been just as impotent and RELUCTANT to stand behind Joe Average and his Wife to defend their pitifully small taxable and non-taxable retirement accounts. The Rape of the Sabine Women pales in comparison to the SEC-allowed financial rape of the American investor.
Your poll indicates that 100% = 77 of the voters demand an SEC investigation.
But it only takes ONE well-heeled and connected hedge fund manager to call off the long ago neutered SEC puppy dog.
Anybody who lost money by selling on the obviously FALSE information on the need for a new FDA AV Panel to review Dendreon’s PV has a RIGHT to be really, really pissed off.
And DEMAND an SEC investigation.
Thanks for at least putting more info about this scandal in print!!!
Mr. Experience
All this reminds me of the old Keystone Kops movies; confused and going nowhere, fast!
HCHack
Should there be an investigation? After what has happened previously with this company and its stock that should not be the question.
The question should be if the Dendreon example of market manipulation and dirty parlor tricks has shaken your confidence in the charade of our financial system.
As a somewhat impartial observer who works in the HC industry and became interested in the Provenge saga a few years back I can’t believe how many times HC financial press simply dismisses those who ask questions as paranoid conspiracy theorists.
kyoto27
Harry Markopolos says in his new book “No One Would Listen” that
“For nine years I was the S.E.C.’s doormat.” He then goes on to say “It was a trip through the twilight zone” and the SEC wasn’t asleep at the switch, “they were comatose.” So Harry may have a pretty good idea on where all the bodies are buried and maybe Ed we need you and what is left of the ‘comatose’ regulators/Fourth Estate to tell the SEC no more body bags. Retail investors have had enough. We need to turn on the Klieg lights and never let the SEC sleep again….
Christopher
I am not an investor in Dendreon but if I were I would be very upset about this. The yahoo message boards hardly provide an authoritative source of objective information but there is enough consistency in comments and anger directed to The Street’s reporting (AF) and its ’sources’ that it seems to merit further scrutiny and action by SEC directed to Favus.
HCHack
Upset about what? “Reporting” of a research note issued by someone who previously seemed to be one of the few people who knew right away after a positive AdCom that Provenge had no chance of being approved. You think thats odd? The man is obviously a mystic.
M. Black
I was about to hit the “buy” button several months ago when it went from about $2 to $20 in a day or so.
And who in gods name are the six people that voted “no”?!?!? Special people. Very special.
MB
Christopher
HCH - ‘odd’ is not the word I would use. If it happens that Favus and The Street are correct I’ll eat my shorts. There, that’s the word I’d use. And perhaps ’spurious’ too.
David, Health Blogger
Provenge is weird. Not many treatments have inspired such debate and confusion - on the surface, it seems to be a significantly effective treatment for Prostate cancer, on the other why didn’t the FDA approve it?
The answer - ignoring political issues - most likely lies in the inherent complexity of how Provenge is made.
If it were just a pill, from what I’ve seen in how the FDA treats cancer theraputics, it would - imo - be a shut in.
Yet the makes ran studies that addressed the issues the FDA raised and answered their concerns.
There’s more to say - you can see some analysis here: http://healthlifeandstuff.com/2010/03/provenge-prostate-cancer-side-effects/
Evelyn Pringle
Provenge is not weird. The massive debate and confusion stem from the fact that this issue is so complex that it would take the average person with no knowledge of prostrate cancer and the cancer treatment and research industry a solid month of research to understand it.
I know first hand because that’s what it took me.
So who, other than someone effected by prostrate cancer, would be willing or able to put in that kind of time to get an understanding of the matter?
Throw the stock manipulation information into the mix and even people with the most avid interest in cures for prostrate cancer will get lost.
David, Health Blogger
Pardon, sometimes I am imprecise with my language -
what’s weird about Provenge is how it is made, by extracting blood, cultivating cells specially to develop an immune response, and reinfusing them.
This procedure strikes me as vastly different and inherently raises the question of quality control and non-standardization.
I have not encountered any other treatment that is made the same way and I have learned about hundreds of medications and treatments.
That’s not to say that there aren’t a dozen similar treatments; if so, please let me know! =) - just that I have never heard of a treatment that is made that way.
From what I’ve seen, Provenge is a real breakthrough for the good; but you’re right, there is always more to learn.
Evelyn Pringle
I haven’t followed it much over the past couple years, but back when I investigated the vaccine, experts were saying that if it proved to be as good as forecast, it had the potential to devastate the cancer treatment and research industry.
If was a very difficult topic to investigate and I wish I could remember more that I do. But without going back and reading the articles I wrote and my research files I wouldn’t feel comfortable in discussing it now.
M. Black
David,
With regard to your note re: “strange manufacture” for Provenge, what is/was it about the manufacture process to you raises the most questions in light of possible risk factors influencing Provenge product safety?
MB
Dan
http://www.mdjunction.com/forums/prostate-cancer-discussions/general-support/292007-the-unreachable-unavailability-of-provenge