Frankie62

3 Reasons Not to Predict FDA Action: Matrixx, Savient, Dendreon

In addition DNDN has a similar treatment for breast cancer - Neuvenge which is in trials. The "packet" technology could have other applications as well. Manufacturing facilities are being prepared in NJ and GA as well as the Seattle location. Final BLA to be filed in Q4.

Stock Watch: TTNP, VNDA, DNDN, AGEN, ONTY

It's hard to imagine FDA refusing to approve Provenge since it met the goals set out by FDA. What a joke it was when the FDA panel voted almost unanimously to approve Provenge, then Dr. Scher etal sabbotaged the approval with their letter writing campaign. The fact that they were biased by their chemo and radiation connections (read $$) was never disclosed. FDA needs major restructuring. Lately they can't seem to approve anything and seem to be going after nit-picking details. Where is Scott Gottlieb when we need him?

Dendreon Investors Learn a Hard Lesson in Stop-Loss Orders

That fiasco was possibly criminal - just because you can do something doesn't make it moral. I was one who saw my portfolio significantly impacted by that one minute period. But you left out what happened the next day - DNDN closed at 22.94 a share. We only had to wait. Over and over on the IV message board experienced investors have screamed not to buy DNDN on margin and not to use stop losses. Besides the "phantom" shares problem which causes margin shares to be lent out, a stop loss can cause what happened the day before. Expensive lessons for some DNDN investors.

DNDN's Provenge will change the standard of care for cancer - it is being tested on breast cancer and other tumors as well as for earlier stage prostate cancer. Side effects are very mild, i.e. slight fever, unlike devastating chemotherapy and radiation - and the patient lives longer.

Dendreon 2007 Annual Report and How Provenge Will Propel Company

sdbanks left out that the primary opponent of Provenge wrote letters urging FDA NOT to approve Provenge for prostate cancer, in spite of the panel vote. There have been lawsuits filed. The same opponent has sources of revenue from the current "accepted" treatment - radiation and chemotherapy (which have devastating side effects), major conflicts of interest. The victims in final stages of PC have been begging for access to Provenge - it not only extends life, but there are virtually no side effects. DNDN's Provenge and Neuvenge are immunotherapies which are customized for each patient, using their individual blood.

Johnson & Johnson Is the Latest FDA Casualty

I agree with cyclingscholar. Allow the patients to decide, with the advice of their doctors. A new life-extending treatment should be allowed, especially when the FDA committee recognized it is effective and safe. FDA is becoming a cya organization - not just for patient risk, but for "consultant" doctor's risk to their bottom line ($$). Many in the FDA have true conflicts of interest - with ties to pharmaceutical companies payments. How could FDA have refused approval to Provenge, when it clearly was shown to extend life and have virtually no side affects? What terminal cancer patient would not choose a treatment with no side affects which may extend his life a few months, or years? Or would they choose to have devastating chemotherapy and be terribly ill for their remaining days? Let the patients decide for themselves - it's their life or death. Whatever happened to "First do no harm"?

Johnson & Johnson Is the Latest FDA Casualty

You may be right, cyclingscholor. FDA seems to have a cya attitude - not just for risk but also for the "consultant" doctors' piece of their pie. Many of them truly have conflicts of interest. Why would they approve a new drug or new treatment (see Provenge) which has virtually no side affects and extends life - their pharmaceutical company "consultant" ties might be negatively affected. But what patient in their right mind would choose miserable chemotherapy treatments if another less devastating immunotherapy is more effective. Let the patients decide, with their doctor's advice. And for goodness sake, separate the evaluation of headache treatments from the cancer and other life-saving treatments.

Frankie
On Nov 27 10:25 AM cyclingscholar wrote:

> How about an announcement like this:
>
> The FDA is fundamentally a flawed organization, attempting to balance
> risk and reward for drugs when this is best left to doctors, patients,
> and their families.
>
> Thus, from this point on FDA is to strictly an advisory agency. If
> they feel a drug is dangerous or ineffective, the sum total of their
> power shall be to issue the following proclamation:
>
> "WE BEAN COUNTERS AND STATISTICIANS AT FDA HAVE TESTED THIS DRUG
> AND FOUND IT INEFFECTIVE AND POTENTIALLY DANGEROUS. USE IT AT YOUR
> OWN RISK, AFTER CONSULTATION WITH YOUR MEDICAL PROFESSIONAL." <br/>
>
> cyclingscholar

Are Dendreon's "Naked Shorts" Running For Cover?

Well, finally the powers that be have decided naked shorting is a problem needing addressing. One of the most interesting "new" requirements is that the "borrowed" shares must actually be delivered by the end of the 3rd day - hmmm isn't that what the requirements were originally? Apparently the rules have not been enforced?! DUH! Too bad it took a financial market crash to remove the scales from their eyes.

As a DNDN stockholder I am definitely interested in this development, but I'm even more concerned with what this week has done to my overall retirement portfolio, even though I am not invested in the financial markets.

Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts

Jose, I'm sorry but I agree with the previous writer who replied to you. Pray you don't get prostate cancer. Those men who have been diagnosed know that they have few choices - remove the prostate if they are lucky enough to have caught it early as my husband did, burn it out with xrays either by external means or by the "seed" technique and/or chemo"therapy". All of those choices for "treatment" make the cure as bad as the disease. No man wants that, so many go without treatment and accept impending death. If the Provenge immunological treatment consists of having blood withdrawn, treated, then reinfused 2-3 times, with virtually no side affects, the choice is a no-brainer. It is morally reprehensible to bar those grown men from that choice if there is even a slight chance it could work. Give them the information and let them make the choice. The FDA panel ruled that it was effective and safe. If it is you, your brother, your uncle, your dad, your grandfather or your son, what choice would you make?

Dendreon: The Provenge Approval Scandal, One Year Later

This story is still amazing to me. What is the point of having an FDA Panel if FDA is not going to pay any attention to it? The safety and efficacy numbers from the Panel analysis show that they believed Provenge is safe and effective. FDA should have at least approved Provenge conditionally,if not outright. Instead, the panelists in the minority (and in the back pocket of big pharma) wrote scathing letters claiming the Panel was wrong in its analysis. What stupidity.