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Arena Pharma: Understanding the Market for Anti-Obesity Drugs
"I expect Medicare to reimburse for Lorqess, because they get it about what obesity is really costing them. And then there's the rest of the world"
There's a lot of wisdom behind those statements!! Thanks, Michael - for your perspective and expertise in 'ALL' of your posts on ARNA (as well as other stocks you follow). I have so much respect for your knowledge. Your comments are always very insightful and astute! I'm so glad you're there to give another expert and logical point of view - and also to clear up any misinformation that may be out there.
Sep 5, 2010. 10:03 AM
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Dendreon Is Not In Trouble!
Thank you for explaining the FACTS about what's going on with the latest 'minor' and 'common' FDA request, and also - for being so bold as to place light on the source of the latest misleading information! Obviously Brian has an agenda for wanting to throw as much negativity into 'one' headline, as he can!
The fact is - as you made clear in your article ... that MOST Pharmas with new products - at one point, will get a hand slap by the FDA, about what they say about their latest product... According to someone who has worked in many different Pharmas - The same thing happened in ALL of them!! It's 'common place'!
For these so-called reporters, bloggers, etc.. to keep harping on something that "anyone" in the Industry "KNOWs" is as little as a "yawn" - just further exposes theses types of articles as having been written by people who are either captured - or have their own agenda.
There's a law about yelling Fire in a crowded theater .. There should be one about doing basically the 'same' thing to a Stock by lying or twisting the facts !!
Aug 10, 2010. 02:27 PM
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Cancer Vaccines: Northwest Biotherapeutics vs. Dendreon
Mr. Garza ...
I first began looking into Dendreon for my father, when he became desperately ill with cancer. I asked a friend who's a brilliant biotech researcher (and in high demand as a consultant to Biotech companies) - which company offered the BEST potential of a non-toxic cancer treatment at that time... hoping I could get my Dad into a trial. My friend told me that although it wouldn't be for my father's type of cancer (at that time) - that PROVENGE is by far - the best proveen treatment out there! It was very effective, was better than the chemo and had only mild side effects, which VASTLY improves the patient's quality of life !!
Your so-called report is so full of holes, inaccuracies, TWISTED facts and lack of ANY "credible" evidence - that it would be laughable, if it wasn't so pathetic.
PROVENGE is now an FDA-Approved Vaccine, which has been 'proven' to WORK! The FDA does NOT (as I'm sure you're aware) allow cancer treatments to be approved, without extremely stringent testing and fact-checking. No one can say that the FDA has left ANY stone unturned, with respect to it's digging into every aspect of the trials - and it's final Approval of PROVENGE!! Now 'that's' a FACT !!
If you REALLY want to present the 'FACTS' - and be taken 'seriously' - go interview the huge percentage of men who have taken PROVENGE (and their families) - who have seen their lives extended "YEARS" from this unique vaccine! Go to the Care to Live organization which has a very good understanding of how and why PROVENGE works, and represents THOUSANDS of men who've been long awaiting PROVENGE's approval.
Here's an idea ... Why not go to the 'SCIENCE' people at 'Dendreon' ??? Ask 'them' to explain it all to you!
Hasn't anyone ever explained to you the statistics on how many Phase l and even Phase ll trials can come out looking like the next best thing, but FAIL MISERABLY when they do a Phase lll ?? It's True. Check the history on that !!
I'm sorry, but you've really proven to the world now that you have NO CREDIBILITY as a 'biotech' writer - and No understanding about the process and results of Biotech trials and products.
Cancer is a "devastating" disease!! Do your reputation a favor ... Get your Facts straight !!
Jul 17, 2010. 09:43 AM
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Why Dendreon's Provenge Must Be Approved
Letter from the Heart (a loving Daughter's Hope and Plea) ....
This will not be a "technically-inspired" message - but rather, thoughts and feelings from someone who has a much-loved Father who's extremely ill now, and who's desperately hoping to find a 'third' modality that will extend his life for a few more years - until another type of treatment can be brought out - before another return of his cancer !! He's suffering from head and neck cancer, which unfortunately can't be helped by the prostate cancer vaccine, PROVENGE, but logic tells me that if the FDA gives approval to it (which I'm 99% convinced it will, based on all of the evidence that CBER based it's overwhelming recommendation for approval on) - then "that" will not only extend the lives of the tens of thousands of men suffering now from UNTREATABLE cancer, but it will ALSO open NEW DOORS for development of other vaccines which will be based on HELPING the immune system to kill the cancer cells - instead of the "Chemo-theory" which is - KILL the cancer,, as well as the "PATIENT" !! I became extremely excited about PROVENGE when CBS did a news segment and played a video which interviewed both Oncologists and men who have been surviving with the help of Provenge. Dr. Berger (North Shore Hemotology), who was doing a final phase trial at the time - said "we have not seen Any Phase 3 trial in prostate cancer, showing a SURVIVAL difference - except for This one" ... and he went on to say "When the cancer cell load is low, we can Kill those cancer cells before they have a chance to spread - Unlike chemotherapy - which attacks EVERY cell in the body!! Provenge ONLY ttacks the Cancer cells !!" He said "this drug is very very low risk in terms of side effects" and that he expects the FDA to approve it. The only side-effects which a man named Charlie was experiencing, was some minimal sweats for a few days. The piece said "It helps men live longer when nothing else has worked!"
Another newer video interviewed Dr. Manuel Guerra in Florida, who said that the patients that it does work for (which is a large percentage) - it Has controlled their cancer. It triggers the immune system to attack Only the cancer cells, and Not the healthy ones!! It's So Exiting to see the birth of a New, Nontoxic form of therapy for Cancer patients - instead of the BARBARIC use of CHEMOTHERAPY, which makes the patient suffer to an Inhuman degree, and after it's virtually rendered the patient completely helpless, and in INCREDIBLE PAIN - patient FINALLY acheives painless peace - by Dying !! When the video was done, the CBS commentators commented that Provenge could control the cancer for a few more years, but that even a "few more months would be a valuable tool !! For people like me - who have loved ones - who are desperately searching to at least, extend the lives of the people whom they cherish - it would be an extraordinary Blessing to be able to spend some more months or years with their cherished-one !!
The doctors who did the trials, and now the FDA Panel, are in agreement that it's completely Safe !! I'm soooo Excited about future this brand new therapy which doesn't Ravage the Patient, and which ENHANCES their 'Quality of Life' !! Won't it be WONDERFUL when the approval of this non-toxic vaccine leads to Other vaccines for other cancers ... and leads to not only Extending life, but possibly (down the road) - actually CURING the disease !! I started reading about Dendritic Cell vaccines about 8 years ago - when my father's cancer came back for the second time, and at that time, I was hoping against hope - that I would see an approval of a vaccine like this - "Before" my father lost his life !!
Dr. von Eschenbach did a half hour interview on C-Span a couple of weeks ago, in which he made statements that seem to me to give alot of hope for Provenge to be approved. The following are some of the exerpts from the interview:
In a comment about how the FDA can review and modify their reccommendations, he stated... "We need to do that in a very 'targeted' kind of way .. we need to do that in a way that is addressing areas where we have greatest concern about potential risk or greatest areas in which we don't have all the knowledge that we need to have, so "We may be APPROVING a drug, but approving it with the realization that once it's used in a large population, we'll have to learn more about it.
We're dealing with a Risk/Benefit ... Certain diseases, like Cancer - we know we Have to have treatments that are in fact, "Life-Saving" .... and therefore the RISKS that come with that - may have to be Greater, but more acceptable ,.. We need to find BETTER Drugs !! That's the bottom line !! We need to be able to Enhance our development of drugs that are going to in fact Improve quality of life with a much lower level of Risk. And so That's why we have to keep this Pipeline really healthy in terms of getting More CHOICES ...
We have to be also very thoughtful and careful about those decisions in balancing benefits and risks, in not allowing things to go forward -that could in fact create more harm than benefit, and I think that's where the "Advisory Panel's help us - in Making those Decisions !!!
too causious ?? We WANT new drugs to come Forward, and into the market place. because people ARE suffering - whether it's from Cancer or from arthritis and they NEED solutions .. We WANT that to happen !! And we're going to continue to be effective and efficient in getting those drugs out there. So we're going to keep guardrails out there. It's a balance.
Part of My goal at the Food and Drug Admin - is to help MODERNIZE THE FDA - where we now are seeing science and technology develop these new life-saving, life-enhancing interventions.
... because people's lives are depending on it !!
I believe we'd be open to "ANY" new product coming forward."
This interview gave me such HOPE that we could FINALLY, FINALLY begin to forge a NEW path into Cancer treatments which don't Ravage the immune system, but rather - ENHANCE it !! The good doctor seems to be saying that he wants the FDA to open new doors into the future - with Safety in mind ... and the fact that the Entire FDA Panel voted that there are No Safety concerns for Provenge makes me Convinced that this drug has a very, very strong chance of being approved.
I want to say "Thank You" to this site for not only allowing the expression of thoughts and REAL FACTs from people who have the knowledge and the expertise to inform us, but which also gives people like me a forum to speak from the deepest place of the heart - to make a PLEA for a CHANGE in way we go about treating this very pervasive and insideous disease !!
With Much Thanks ....
May 4, 2007. 08:15 AM
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