Yes there are many names and it can get confusing for the reader, but repeating the same stuff over and over again is NOT the right strategy to get over that.

I’m a very avid reader and interested in this topic and I’m struggling not to give up at this point. You have probably lost most readers by piece #2.

Nice work with the charts!

Map 1:
http://www.flickr.com/photos/39874373@N03/3684680219/sizes/o/

Map 2:
http://www.flickr.com/photos/39874373@N03/3684680227/sizes/o/

http://seekingalpha.com/article/138920-stanford-financial-s-cfo-laura-pendergest-holt-a-victim-of-overzealous-regulators?source=yahoo

“show” vs “establish” vs. “is there”

Apparently nobody seemed to notice that we have not two but three phrases in the Provenge Panel question controversy: “show” vs “establish” vs. “is there”

(It all depends on the meaning of “is”

Many point out that a regulatory form question should have been:
“Does Provenge show substantial evidence of efficacy?”

But it was never asked in that form!

At first the question was posed as:
” Does the submitted data establish the efficacy of…”

And after the aborted vote which seemed to go toward “No” answer, it was changed to :
” is there substantial evidence that the product is efficacious.”

One can argue that it was changed from a too strong one to a too weak one.

“establish the efficacy” is more demanding than ” to show substantial evidence”
“is there substantial evidence”: is a weaker standard than “show substantial evidence”

Some people will perceive these phrases as three different ones, some as two different ones, some as all the same.

In mathematics “to show” is used interchangeably with “to prove”. So some people with scientific background may feel that “to show” and “establish” are equally strong. And many may feel that “is there” is a weaker then regulatory(?) “to show”.

It is clear, that the Provenge panelists perceived “is there” as weaker requirement than “establish”.
But the supposed proper question “to show” was never asked.

In my opinion (I knew you would ask:-) the question posed to the Panel was at first more demanding than regulatory one, and then it was changed to a weaker one than regulatory.

With all this in mind, I believe that analysts questioning CEO about this phrase changed in the middle of a vote, and asking if FDA will be happy with the change, was very much appropriate. In fact it should have been cleared up by the CEO perhaps in consultation with FDA. But both FDA and Dendreon’s CEO apparently don’t like transparency.

Chapter-7 had plenty of space to quote verbatim all the meaningless congratulatory statements but found no space to even note that the controversial question and it’s change. Pretending that it never happened and analyst were asking questions in vacuum.

As Ocyan suggested in his post http://investorvillage.com/smbd.asp?mb=971&mn=287784&pt=msg&mid=7535019 one can search FDA web site.

I found that the phrase “establish efficacy” is in fact quite common. See the examples referred below.

So?

Well, perhaps a conspiracy? Or perhaps this word-use politics go much deeper than Provenge. Perhaps different people use different wording to influence others?

I don’t know about conspiracy, it is the Mitchell’s domain.
But I do see how people often replace words with a seemingly similar ones, and yet inappropriate.

I already gave an example of word-politics from this very chapter-7, where Mitchell used inappropriate “panel-approved drug” to make his case stronger, knowing that Panels don’t do “approvals”.

So was the Panel’s 2nd question a result of a conspiracy or FDA politics or an innocent screw-up. I don’t think we will ever know. FDA likes to compete with CIA in keeping their internal processes secret from the public they serve.

Those that want to improve FDA should push for changes in regulations, for greater transparency, for minimizing conflicts of interest, etc… This anti-conspiracy crusade is just a distraction.

The links between FDA politics and Wall Street shenanigans if any, are most likely not a conspiracy but elements of COI.

= = =
Note_1, for those not familiar with Dendreon-Provenge story.
The 2007 Panel’s question-2 is now subject of the “conspiracy” theory, or an example of FDA politicking of the worst kind. It is not material any more to Provenge approval, which stands mostly on the strength of its newly completed in 2009 Impact trial.

Note_2. This perhaps should be posted on the IV Dendreon board. But IV board owner arbitrary censors posts. DeepCapture is so far remarkably patient with critics, as well as with some of it’s supporter’s gutter language and “subtle” idiotic threats to me.

= = = = = =
FDA examples:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf
Data submitted to the FDA was insufficient to establish efficacy in any childhood malignancy.

http://www.fda.gov/ohrms/dockets/ac/96/questions/3198q1.pdf
Do the results of the open-label, historically controlled studies conducted in France establish the efficacy of this regimen for use in the United States?

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm070430.htm
“For phase 3 studies, the sample size is often determined by the number required to establish efficacy of the new vaccine, which may be in the thousands or tens of thousands of subjects. ”

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm072130.htm
Guidance for Industry: Safety, Efficacy, and
“Phase 3 clinical trials conducted to establish efficacy and safety. ”

http://www.fda.gov/NewsEvents/Testimony/ucm114741.htm
Potential Merits of Cannabinoids for Medical Uses
“These studies establish efficacy for a particular indication, examine additional uses, may provide further safety data …”