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Dendreon Corp. Message Board

  • jp11576 jp11576 May 9, 2007 3:03 PM Flag

    FDA Questions??? Please advise

    Debdreons website makes it seem like they just need to get FDA some simple data yet they also say they need clarification on what the FDA wants. Shouldnt they have this info. Do they need to wait till third trial completed in 2010? Am i reading this correctly. Why hasnt the dam CEO said somthing. Also, please dont bash me. i have respected shorts the entire time. i invested a lot of money and concede i went over board with my investment. Honest answers please as i have always tried to do....

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Well, at least you didn't go as "overboard" as you would have had you heard that the UBS call was a hoax in time!

      I can't believe you are as shameless as to nonchalantly post today.

    • They knew it wasn't going to be approved, Its not like they are new to this shi...t.
      They pumped it up and allowed us to bit then over night while everybody was sleeping they cut our heads off.
      Laugh it up scum bags your day is coming!!!!!

    • Anybody else curious about the TIMING of this FDA request? How long does it take a TEAM of allegedly highly skilled, highly experienced, experts to figure out they need more information?

      Also, did anybody else post the Forbes' take on Dendreon's PR
      http://www.forbes.com/2007/05/09/dendreon-provenge-fda-biz-sci_cx_mh_0509dendreon.html?partner=msn

      I missed that part in the notice that said "... the U.S. Food and Drug Administration rejected the company's main product, Provenge. ..."

      Could be the reason why every talking head is yelling, "Get out, now!" Or, maybe there are other reasons ....


      Still LONG and Still Buying

      • 2 Replies to grace45
      • edwardsdesigns@verizon.net edwardsdesigns May 9, 2007 5:46 PM Flag

        I was up big, now I am down big. I was using trading money for now. I almost wish it would go to 3.50 again so I could double down. I am disappointed with both sides on the approval. As a shareholder I deserve to know exactly what transpired. Because of the gap down, I will not be selling now. I will stay away from this message board. AOL and MSN are much more civil. The nonsense that goes on here is a shame. Professional athletes and business men and women do not act in this manor. Like I said 1 month ago- act like you have been there before.

    • Why are you calling me names like a child. I have a good position here and am betting on my statement.

      If I lose i can write off todays loss vs my capital gains from my initial purchase.

      Regards

    • This story reminds me with Erbitux. FDA declined to approve the stock was hammered from $70 to single digit. Few months later the drug was approved and the stock recovered. The vaccine is much easier on patients than chemotherapy. If it is not inferior to chemo it will be approved. You have to have the data to get the FDA support.

      • 2 Replies to asoltan
      • Not even close to Erbitux. Erbitux doesn't take three years to get results from a trial. I believe the median survival data for Erbitux was 10 months.

      • JP - It does not seem to be simple ---

        this is what was posted (see below) on the DNDN website. The very first sentence is for additional clinical data - Mostly they may seek interim data - mid 2008??. Hard to agree that they are seeking additional pieces of the exisiting data. We will know when the company clarifies with FDA.

        "The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The Company is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA, which the Company believes it can supply to the FDA in a timely manner."

    • This is standard in this situation. The company will meet with the FDA in the coming weeks to get more elaboration on what is needed. Only after that will we know what is needed and how long it should take. Personally, I think they'll want to see the results of the ongoing trial that are due in 2010, given the failure of the prior Phase 3 trials to meet their goals as well as their poor design. I would be surprised if this was just a need for a little more currently existing information.

    • the letter from the FDA to DNDN stinks. From my experience the FDA should be following a special protocol to approve new meds for the terminally ill. The request from DNDN is for a med for the terminally ill prostrate cancer patient, not the mainstream patient. The basic sequence for approval is a double blind phase 3 clinical, results that indicate the med is safe, results that indicate limited side effects, and results that support improved quality of life and life extension. Where did DNDN miss? I believe it did not miss and that the FDA needs alittle more clarification. Mean while, the shorts have a picnic and DNDN is approved in a few weeks or months. Yes this stinks. JMO.

    • personally I think data request to get 2b totally enrolled prior to market release. Although it is possible the ongoing study will have to be finished prior to approval.

      • 1 Reply to cqd77
      • JP....IMO silence is a good thing. Gold is greedy (good and bad) but you have to know he had offers to buy-out after the advisary meeting. He knows he is NOT in this for the long haul and IMO he will take an offer that still makes $ from here BUT much less than the 30+ that everyone here was calling for.

        My prediction....low to mid teen buyout within 30 days

        Good luck

 
DNDN
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