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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 74344  
Subject: Another letter... From Hussain this time Date: 4/26/2007 1:11 PM
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http://www.forbes.com/2007/04/26/dendreon-provenge-prostate-biz-cx_mh_0426dendreon.html?partner=yahootix
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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30748 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 1:28 PM
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This is getting a little old. I am highly suspicious that these letters are made known to certain institutions before they are released. After all, it doesnt violate any law, and all a hedge fund has to do is talk to Hussain and ask if she is writing one. That would explain the continued high short interest. When you know a bomb like this is coming... again... its pretty safe to be short.

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Author: cheung62 One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30749 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 1:32 PM
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Fire the Scher salvo; wait, unleash Hussain salvo. Are we going to get letters from the other 2 nay votes as well, or do they not have the necessary credentials?

Man, this battle royale is one for the ages -this time, it *IS* different!

Otter, are you still worried about the general public joining the "herd mentality" on this board?


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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30753 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 1:50 PM
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<<<One big problem for the FDA, Hussain alludes to in her letter, is that the large study that Dendreon is conducting might become impossible to do if Provenge is approved. This 500-patient study is comparing Provenge to a placebo version of the treatments. Ethical considerations might require switching those patients on placebo to the drug, if Provenge is approved. Even if they don't, patients may drop out of this study instead of risking not getting the medicine.>>>

The logical conclusion here is contradictory. If approved then ethically the placebo group needs to be given Provenge. But that is only if Provenge is likely to be effective.

If Provenge is likely to be effective, then is it not unethical to disallow access to this safe drug to the 10s of thousands of additional patients who are not in the clinical trial? Yes, yes it would be.

One thing is clear: The drug is safe, at least in comparison to all other cancer drugs, and there is substantial evidence of efficacy in any objective evaluation. What it does not have is the usual ODEC signature of approval.

Sorry, does not hold water.

Btw/the vote was 13-4. Wonder why they are not citing comments from those who voted for Provenge's efficacy? There were many voices there who were quite excited by Provenge. Instead they quote just 2 persons for those who voted against. Both of whom that will have nothing to do with the final FDA decision. Much like the JP interview with specific thought leaders oncologists. Funny, if you went to Berkeley and talked with thought leaders there you probably would have thought that there was no way John Kerry could lose the 2004 election either.

How do we know that these two people will not have any influence on this decision? If they were having any influence they would not have wrote a letter and had it published. They would have gone straight to the source, those people making the decision. You go outside the decision making hierarchy only when you need to try to channel outside resources to get a bureacracy to your way of thinking.

I'm going to take a nap so I can get some real work done.

Tinker



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Author: franksmartin Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30769 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 3:07 PM
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Thanks Hussain I got more at 15.1

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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30773 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 3:25 PM
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Tinker,

I think you dismiss Hussain's argument to easily. I actually think this is an argument with credibility that requires looking into how confirmatory trials are conducted, specifically re: Iressa.

Hussain is saying that she does not believe Provenge has established its efficacy, however likely it is. This is given some credence by the statements of the panel members all of whom suggested they'd like to see 9902B. The seeming middle ground of approving and following up with a confirmatory trial, she suggests, is not feasible. If the FDA approves Provenge then it is endorsing Provenge, and it is hypocritical to ask patients to possibly receive placebo or to expect them to accept the possibility of receiving placebo. Since everyone wants to see 9902B, and since 9902B is infeasible by the above if Provenge is approved, then Provenge should not be approved until 9902B is complete or we will never know for certain it works. I don't see anything logically inconsistent at all.

Potential responses:
(1) The great likelihood that Provenge works means it should be made available anyway.
(2) Have these problems actually held true with other confirmatory trials?
(2) Are there other ways of testing Provenge's efficacy than with 9902B as it stands?

-Devon

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30775 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 3:33 PM
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Devon,

No I don't buy the arguments. If the drug is substantially like to work with no material side effect then it is as unethical to withhold it now as it would be to withhold it from the placebo group, except more so.

As for the confirmatory trial, there has been a call for quite some time now to use more modern methods of clinical testing. With prostate cancer you have nomograms that rather accurately predict mortality. If a group of 500 men are taking provenge, and then following up with taxotere, and a 1/3 of them are living 3 years or longer, that ain't just whistling placebo effect. Or if they are living 14 months longer than expected, that ain't just whistling placebo effect. One could argue 2, 3, even 4 months may be placebo effect, but not the type of results seen in 9901. The trial can be run without a control arm given statistically what is well known and understood about the progress of this disease.

I have no reason to think this doctors opinion is not legitimate and genuine. However, it does not hold up outside of laboratory conditions. Yes, if you were treating mice then the doctor has a point. We are not treating mice, and we are not in the laboratory. We are in the real world with sick and horribly dying men.

This also is not Iressa.

Finally, I don't think the doctor's opinion means a hill of beans in the final decision. 13-4 was the vote. ODEC is not making this decision. Case closed. Nothing is new here. This doctor already voted against Provenge.

Take 5 random opinions from the 13 who voted thumbs up. You will probably find 5 opinions for approval that are more persuasive than the 2 against. Dr. Scher, his opinion is not necessarily consistent with th data or other statements he has made. This doctor, I have no reason to have a beef with the motivation. However, to release the document publically? That is a sign that the doctors opinion was not being paid attention inside the institution.

Tinker

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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30777 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 3:36 PM
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Good point about the nomograms. I'm glad you brought it up. I wouldn't be surprised if 9902B was amended to be all Provenge with the comparison only to nomograms. True, it is not the best controlled study, but with such a large patient population there shouldn't be anything grossly irregular.

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Author: WeekendHack Three stars, 500 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30785 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 4:15 PM
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Tinker:

For an article by Hussain? I thought you said you were just going to leave the garbage to the garbage men from now on? There is nothing of any substance being put out from any of the media outlets. There just isn't.

WeekendHack

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30787 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 4:20 PM
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No, there is not. Just another topic to respond to.

The only change in news: May 15 is now another day nearer. Still, one does like to find out immediately why one's portfolio has precipitously dropped in just an hour. And so we have found the cause.

I am signing off. Wasted too much time on it. Should be getting work done, and I am taking care of the twins all by my lonesome this week. Wife had a bit of the under the knife and is out of condition for such tasks at least through the weekend. How do I do it? I shirk off my day job, that is how.

Oh well, just work tonight after the youngans are put to bed.

It was worthwhile to find out what the news was all about since the stock reacted so virulently to it. But time to detach from it. May 15 a day closer should read the headline.

Tinker

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Author: WeekendHack Three stars, 500 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30792 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 4:46 PM
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"However, it does not hold up outside of laboratory conditions. Yes, if you were treating mice then the doctor has a point. We are not treating mice, and we are not in the laboratory. We are in the real world with sick and horribly dying men."


I think this is the point that, at some point in time, just about EVERYONE does not fully realize. This is not a lab, and it isn't going to go exactly as you drew it up. There are going to be audibles. In this case the audible was an increase in survival. The scientist sees it didn't hit its primary end point, while the doctor side sees so what there was a drastic increase in survival and was SAFE. That is why you saw the panel give it's approval (although they never were to vote on approval), and why the FDA will follow that.

Put it this way, if we did not have Von E in charge I would give the bear case a lot more weight. I for one am pretty good at judging people. Body language, speech, etc. From listening and watching Von E (and understanding the story) it seals the deal. Could something crazy come up? Sure. Is it likely? NO. Could Von E be completely full of crap? Sure. Is it likely that he has been lying through his teeth when he has been spreading the "bridge not barrier" message? Not very likely at all.

The bottom line is that things do change, but they take someone to initiate that change. Most of the time you would be right to read the letters from Scher and Hussain, and think that given the way the FDA is it is not going to approve this. Different time, different regime. Without Von E at the helm this is a completely different discussion, because we all know the history of the FDA is to deny or issue approvable with further testing when it comes to drugs with numbers like Provenge. That really isn't the case now though. Some are going to be completely against the change whether they have an ulterior motive or not. The fact is 13 out of 17 saw Provenge through the "new" FDA lens or at least what Von E would like to see as the new FDA lens.

Frankly, arguments that state there is no way Provenge should be approved, given its safety profile and the label it is going after, are just old thinking. There is absolutely no way you will ever come across a cure for cancer if you can't even get the new wave of drugs on the market and let the market be the test bed. The linchpin in all of this is the safety profile. If a potentially ground breaking drug like Provenge shows that it is safe, it should approved so that the patients in the market can be the true test bed. That's not just us on this board saying that, that is essentially what the head of the FDA has been and continues to say. It has been a long time coming, and thank goodness it could finally here. Like I said, I've never lost anyone to cancer, but I sure as hell wonder a lot who will be the first one.

Okay. That was it. I am not reading anything else between now and 5/15 that had anything to do with the Cancer Letter.

WeekendHack


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Author: McTwidget One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30794 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 5:03 PM
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So in doing some quick research on the "Cancer Letter."
http://www.cancerletter.com/

One can make their own judgements about the quality of the site and information....but I'm generally not impressed.

One thing of note, the same issue of the newsletter that published the Hussain letter also had this summary:
"Dear FDA: Provenge Provokes Letters From Opponents, Advocates,
Investors. FDA Should Delay Provenge Decision Pending Definitive Trial
Results, ODAC Chairman Writes. Patients "Raise A Voice" For Provenge
Approval. Ad Hoc Internet Group Send Rebuttal To Scher's Letter. In the Cancer Centers: Trump Named President and CEO of Roswell Park;
Piantadosi Is Director At Cedars-Sinai; Ratliff To Direct Purdue."

Notice the other two articles that Forbes completely glossed over in publishing their article. Selective referencing at its very finest...thanks for providing both sides Forbes.

Good luck all
McT

PS- And for any bears...yes, I am aware that the ODAC chairman is a bigger story...but let's at least attempt to let the readers know the whole story.


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Author: mauser96 Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30810 of 74344
Subject: Re: Another letter... From Hussain this time Date: 4/26/2007 6:52 PM
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Advisors Voted For Provenge Approval Despite Fundamental Flaws In Trials. Memorial's Scher Warns FDA About Flaws In Provenge Data, Urges Not To Approve

Above from the Cancer Letter. Note the . between "Trials" and "Memorial's." The period makes the statement an editorial, whereas a comma would make it reporting. Was this just an error, or deliberate?
In any case it is just another newspaper, run by journalists, not a scientific journal.Newspaper people are the same everywhere. They have space to fill, they don't know much about the subject so they go to available outsiders, ones that will answer the telephone. The outsiders are busy people, the ones most likely to return calls are those with agendas.

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