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1. [verwijderd] 21 december 2006 16:03

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   Dan zal mij het benieuwen hoe de statistics van 2004> 2006 zijn imo.??
   
   RB
   
2. [verwijderd] 21 december 2006 16:04

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   quote:

   snor13854 schreef:

   Dan zal mij het benieuwen hoe de statistics van 2004> 2006 zijn imo.??
   
   RB
   
   

   mij benieuwd vooral of de 4$ het houdt
   technisch oversold
   shorts groot nog aanwezig met 11-12mln aandelen short
   
   daling eerder deze week ging gelijk met spike in call opties, dus dat waren gecoverde shorts om verkopen uit te lokken
   
   ik denk als het ze deze week niet lukt om de 4$ te breken dat de kans groot is dat ie erop bounced..
   daarna tot 9 jan ivm bericht priority review
   
   en hopelijk herstel uptrend, want dan loopt de klok!! en wel vanaf definitieve filing BLA in nov is het dan max 6 maanden naar begin mei
3. [verwijderd] 21 december 2006 16:36

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   Daarmee zeg je het al gecoverde shorts om verkoop uit te lokken,en dat zal heus wel een beetje lukken,maar time is short,elk moment vanaf nu kan de priority review er komen,dus er staat een ommekeer voor de deur,die vervolgens een verwachtings upswing gaat maken,zo de aanloop naar eind januari zie ik een pos. opgaande koers komen,en by good news,tja,een rekensom,waarvan alreeds wat geexperimenteerd is,maar....ja $10 lijkt mij dan haalbaar.
   Kijk lokken om te verkopen,vereist bijna om bij te kopen!
   
   RB
4. [verwijderd] 21 december 2006 16:58

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   quote:

   SkySpam1 schreef:

   [quote=connect]
   
   ps: succes met gtcb, nog geen 10 euro zoals door jouw voorspeld voor dit jaar maar t scheelt niet veel.
   dwz een nul scheelt t.
   
   als je nog meer tips hebt hoor ik t graag.
   
   mvg,
   [/quote]
   
   het zit je blijkbaar wel allemaal wel erg hoog,
   om steeds iemand anders de schuld te geven
   en ja hoor, want die ander heeft hieraan steeds de schuld
   makkelijk toch, om deze steeds met de vinger te wijzen
   had het positief geweest, was je er zeker nietop teruggekomen
   je wijst merendeel alleen op de nega-kant
   
   achteraf praat het allemaal zoveel makkelijker !!
   

   nou zeg, het aardige van een forum is juist dat je terug kunt kijken, en je zo een waardeoordeel kunt vormen omtrent posters.
   
   het valt op dat iemand hier fanatiek post en met krankzinnige koersdoelen argeloze lezertjes zelfs t geld in de pocket doet duizelen, en plotsklaps is de persoon verdwenen.of valt jou dat niet op.
   
   dit is bij meerdere fondsen gebeurt. meer dan noemenswaardig lijkt mij.
   
   wat betreft complimenten, toevallig heb ik ronson op het qurius forum vandaag nog gecomplimenteerd.
   ere wie ere toekomt, simple as that, maar ook de keerzijde van de medaille niet verwaarlozen.
   houd menigeen scherp.
   
   als jij om een compliment verlegen zit sky, lees maar eens terug op het gtcb forum, ook daar deel ik complimenten uit oa aan jouw.
   
   lekker fris geheugen heb je.
   
   mvg,
5. [verwijderd] 21 december 2006 16:59

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   zonder die dilutie hadden we nu op 6$ gestaan
   stevige uptrend intact en 5,50
   
   dus tja connect , zo kan je alles wel beschouwen als negatief
6. [verwijderd] 21 december 2006 18:17

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   Inmiddels onder vier,vanaf nu gestaffeld bijkopen,simpel,goedkeuring,ach....duurd 4 weken,intussen gaan de koperertjes jagers aan de gang,ga je gang maar tot what ever,het product zal zeer binnenkort toch de omwenteling laten zien in de koers.
   
   RB
7. [verwijderd] 21 december 2006 23:22

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   quote:

   crackedtooth schreef:

   zonder die dilutie hadden we nu op 6$ gestaan
   stevige uptrend intact en 5,50
   
   dus tja connect , zo kan je alles wel beschouwen als negatief
   

   ja hallo, zo ken ik er nog wel een paar.
   
   als er maar 1 miljoen aandelen hadden uitgestaan deed de koers vandaag 290 dollar.
   
   maar er staan geen miljoen aandelen uit, en ja er zijn extra aandelen uitgegeven.
8. [verwijderd] 22 december 2006 16:47

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   quote:

   connect schreef:

   [quote=crackedtooth]
   zonder die dilutie hadden we nu op 6$ gestaan
   stevige uptrend intact en 5,50
   
   dus tja connect , zo kan je alles wel beschouwen als negatief
   [/quote]
   
   ja hallo, zo ken ik er nog wel een paar.
   
   als er maar 1 miljoen aandelen hadden uitgestaan deed de koers vandaag 290 dollar.
   
   maar er staan geen miljoen aandelen uit, en ja er zijn extra aandelen uitgegeven.
   

   je eerste opmerking was nog onzinniger
   wou je even laten zien dat ik dat ook kan
   
   tsk
   
   bij biotech gaat het nog altijd om timing..
   en goed/afkeuring
   
   en bij goedkeuring dndn dan maakt het geen klap uit of je op 4$.4,50 5$ of 8$ hebt gekocht
   
   en eerdere data was vertraagd.. dus daardoor timetable anders
   
   
9. [verwijderd] 22 december 2006 20:04

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   zo, goede bounce off the 4$
10. [verwijderd] 22 december 2006 22:28

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    Zo is dat $4.29.
12. [verwijderd] 26 december 2006 23:57

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    Msg: 23609 of 23614 12/26/2006 5:23:29 PM Recs: 5 Sentiment: Not Disclosed
    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 23581 by ocyan
    
    Re: A few comments on CD54 and Provenge
    Ocyan:
    
    1. Good summary. I also suggest that anyone interested take a look at the following three studies/presentations, the last of which is a Video Webcast by the author of the first of your citations, Professor Uli von Andrian of Harvard..
    
    2, Costimulation of naive human CD4+ T cells through intercellular adhesion molecule-1 promotes differentiation to a memory phenotype that is not strictly the result of multiple rounds of cell division Volume 118 Issue 4 Page 549 - August 2006 doi:10.1111/j.1365-2567.2006.02396.x www.blackwell-synergy.com/doi/abs/10....
    
    3. Central memory self/tumor-reactive CD8+ T cells confer superior antitumor immunity compared with effector memory T cells Published online before print June 24, 2005, 10.1073/pnas.0503726102 PNAS | July 5, 2005 | vol. 102 | no. 27 | 9571-9576 www.pnas.org/cgi/content/full/102/27/...
    
    4. NIH Video Presentation at: Migratory Properties and Immunological Consequences of Dendritic Cell MigrationMigration
    Wednesday, October 25, 2006 Uli Von Andrian videocast.nih.gov/PastEvents.asp?c=28
    
    5. The von Andrian presentation seems to suggest that the source of the matured antigen presenting cells, in both the case of his presentation, as well as in the ex vivo maturation in Provenge, from progenitor peripheral blood monocytes (PBMC), may be of comparable significance to Provenge’s expression of ICAM-1/CD54. von Andrian seems to suggest that T cells primed by dendritic cells in large part take up residence in bone marrow where they become a significant source of highly proliferative memory T cells. ICAM-1 is also associated in the other studies with the preferential creation of a memory T cell pool. The T cell proliferation data released in the P11 ADPC study of 93 prior to a Provenge booster that raised it to over 200 would seem to confirm an extremely robust memory T cell response.
    
    6. The more confusing derivative question is how this ties into the effector phase function. For example, dendritic cells recruited at the site of an intradermal vaccination generally migrate through the lymphatic system to a draining lymph node. Evaluation of in vivo labelled dendritic cell migration in cancer patients J Transl Med. 2004; 2: 27. Published online 2004 July 30. doi: 10.1186/1479-5876-2-27 www.pubmedcentral.nih.gov/articlerend... Also: A 2003 study in mice of skin sourced mature dAPC’s found that approximately 12% of dAPC’s transfected at skin reached draining lymph nodes within 3 to 4 days, and persisted in vivo for up to 14 days, far longer than previously thought. Genetic tagging shows increased frequency and longevity of antigen-presenting, skin-derived dendritic cells in vivo Nature Immunology 4, 907 - 912 (2003) Published online: 10 August 2003; | doi:10.1038/ni962 www.nature.com/ni/journal/v4/n9/abs/n...
    This does not appear the case for T cells primed with dendritic APC’s matured from PBMC’s. Whether or not the chemokines that attract these T cells through the lymphatic system also attract T cells or actual dAPC’s from circulating blood to tumor cells near draining lymph nodes or whether some other mechanism does the same may be a good question. There is a CD107a diagnostic test that can determine whether T cells in the vicinity of cancer cells retain the ability to kill them that nay help address that question. Ex vivo identification, isolation and analysis of tumor-cytolytic T cells Valerie Rubio, Tor B Stuge, Naileshni Singh, Michael R Betts, Jeffrey S Weber, Mario Roederer, Peter P LeeNat Med. 2003 Nov;9(11):1377-82. Epub 2003 Oct 5 www.ncbi.nlm.nih.gov/entrez/query.fcg...
    
    7. The high level of regulatory T cells found generally in the microenvironment of established tumors(See: Intratumor depletion of CD4+ cells unmasks tumor immunogenicity leading t o the rejection of late-stage tumors, www.jem.org/cgi/content/full/201/5/779 ) as well as the work of Dr. Charles Drake of John Hopkins specifically relating to Tregs in prostate cancer may explain why Provenge does not generally precipitate objective tumor responses or complete remissions in AIPC/HRPC, and suggests strongly that Treg depletion strategies and the use of “checkpoint regulators” to inactivate Tregs, such as antibodies against CTLA4, PD-1 and LAG 3 may offer the potential of substantially enhancing Provenge’s effector phase results. See: Blocking the regulatory T cell molecule LAG-3 augments in vivo anti-tumor immunity in an autochthonous model of prostate cancer.
    www.asco.org/portal/site/ASCO/menuite...
    61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=40&index=y&abstractID=34920
    
    8. In any event long term memory T cells primed against and attacking PAP expressing cells, metastacizing to vital organs and unprotected by concentrations of Tregs may explain the long term survival benefits even in the absence of near term objective tumor responses or complete remissions. All JMHO.
    
    Good luck to you and to all DNDN longs.
    
    
    Email this page to a friend
    
    
    
13. [verwijderd] 27 december 2006 09:28

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    priority review - everyone knows
    www.fda.gov/cber/gdlns/reviewpdufa.pdf
    
    Every time I read this document, I am puzzled at the number 30 in parenthesis with footnote superscript #6 in the first row of the timeline column, page 11, filing review and planning table. The footnote says "The number in parentheses indicates modification of timeline for priority status reviews."
    
    In the second column, major activities are in bolded text. Set the puzzle aside for a moment, curious mind wants to know what will FDA do during Day 0-45.
    Day 0-45 (30):
    1. Request consult (doesn't sound interesting)
    2. Identify inspection actions. Imaginatively, a PET scan starts to paint orange once my visual cortex detects the following text - coordinate preapproval inspections (PAI) for BLAs, request investigations of clinical,non-clinical, and biopharmaceutics research site - Jerzee's guard story came to mind - which brings another question, what the hell is day 0? Nov 9 was when the last section of CMC was filed which completed the BLA, and should be day 0, or shouldn't it? )
    
    Day 0-45 (30)again
    3. Applicant orientation presentation (optional)
    4. Designate priority review status (priority or standard): PET scan shows visual cortex bloody red!
    5. Conduct filing review (with subheadings speaking to the effect of whether there is review issues)
    6. Convey RTF (refuse to file) issues to applicant.
    
    By Day 45 (30)
    7. Hold filing meeting (FDA internal), and 8. make filing decision
    By Day 45 (30)
    9. Conduct planning meeting (with filing meeting where possible) to plan for and schedule the following (my interpretation - if RTF, then this wouldn't be necessary):
    Periodic team progress check-ins
    Mid-cycle review meeting
    Team or subgroup interaction on particular issues
    Primary review completion
    Secondary (team leader or branch chief) review
    Review division director, or higher level, review
    Consult review input
    Advisory committee meetings
    Internal briefings for signatory authority
    Wrap-up (integration of review, consult, and
    inspection input)
    Preapproval safety conference (CDER) CDER MAPP 6010.1, NDAs:
    Preapproval Safety Conferences
    Preapproval facility inspections (BLAs)
    Labeling negotiation
    
    By Day 60
    10. Issuance of action letter by PDUFA goal date
    11. Communicate filing determination if RTF (no wonder of today's reaction, some folks may think no news is bad news, fine, go ahead and sell, be defensive if you want)
    
    By Day 74
    12. Communicate filing review issues to Applicant (this is if, if the application is accepted for review, ie no RTF).
    
    A little light headed, must be that mixture of Moutai and Tsingtao made it through the BBB.
    
    My reading of the tea leaves, forget Jan 9, FDA knew by 12/09, DNDN probably knew by 12/09 (if that optional 45-day or shall I say 30-day presentation). Our CFO must know, he knew that there was not going to be an RTF, he knew about the PAI, knew about the priority review, and he made sure he knew and had Gold swear to him that those were true, and he joined DNDN.
    
    
    
14. [verwijderd] 28 december 2006 18:08

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    Msg: 23802 of 23904 12/27/2006 7:09:42 PM Recs: 62 Sentiment: Strong Buy
    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Provenge, Chemo, Immunotherapies and the FDA; Bringing All of it Together in 2007
    1. One of the somewhat overlooked comments by Gold in a recent CC was that there was an average 10 month period between Provenge therapy and the time those taking Taxotere commenced that therapy. As Dr. Petrylak's November presentation described, the combination of Provenge followed by Taxotere obviously synergistically increased median survival significantly more than either alone (11+ months). Given the interim period between the therapies, the Provenge impact logically was derived from circulating memory T cells primed by Provenge's dAPC's, rather than effector phase CD8 T cells (although some of these also naturally progress to a memory phase). Taxotere, a cytotoxic that preferentially attacks rapidly proliferating cells, would not be negatively impacted by regulatory T cells, and, in fact, since initially Tregs proliferate far more rapidly than effector T cells, might preferentially deplete them. In addition, inflammation caused by cell destruction releases chemokines that can attract circulating memory T cells to the inflammation site. Cancer cell destruction also releases antigens that can be taken up by local helper T cells and "immature" dendritic cells, leading to the "epitope" (aka "determinant") spreading or antigen cascade, widening the impact of the immune attack.
    
    2. The rapid autopsy program in prostate cancer found that most AIPC cells are indolent (grow slowly), which is why chemos have not been particularly effective with AIPC. That suggests a practical clinical question as to whether there is a law of diminishing returns effect with Taxotere, where, especially given its side effects and high pivotal trial dropout rate, the full 7 month course of Taxotere therapy may not be required for most of the synergy.
    
    3. IMHO, there is somewhat of an evolution taking place between the recognized leaders in immunotherapy at the NCI and the chemotherapy community. The NCI's Drs. Rosenberg and Restifo focus overwhelmingly on end stage melanoma, where the "effector phase" immune attack, as opposed to the memory phase, either succeeds or the patient dies. They have recently raised long term survival rates in end stage melanoma from 7% to 15% to 35% to 50% by genetically engineering ex vivo T cells primed against a gp100 melanoma antigen to overexpress IL-2 and IL-15, thereby increasing their ability both to persist in vivo and to lyse cancer cells, and have infused large numbers of these T cells into patients, treated prior to infusion with therapies that deplete Tregs. OTOH, the NCI's lack of statistical success with the PSA targeted fowlpox vaccine jointly being developed with Therion did not infuse any mature dendritic cells, depended on in vivo recuitment of dendritic cells, and would have preferentially created effector phase T cells. PSA is apparently also a poor immogenic target; the vaccine only produced a median T cell proliferation of 3.3. An initial conclusion expressed by Dr. Rosenberg at the NCI's 9/05 Immunology Symposium was that if a vaccine doesn't show substantial evidence of tumor regression or complete remissions initially against growing cancer cells, how could it be expected to extend survival (although he then commented that he could be persuaded by a clinical trial). The "chemo camp" comes to a similar conclusion from a diametrically opposite perspective, but would agree that if you can't kill a cancer cell, the rapid growth and mutations of cancer would overwhelm any static defense. Nevertheless any oncologist would acknowledge that hmabs that use antibodies to target cancer cells for T cell destruction have been remarkably effective.
    
    4. The first of two doctors who might be condidered "agents" of this evolutionary process of changing perspectives may be Harvard's Dr. Ulrich von Andrian, whose explanation of trafficking within the immune system, backed up with remarkable visual tapes, enlightens as few others can how dendritic cells and T cells function in vivo. Migratory Properties and Immunological Consequences of Dendritic Cell MigrationWednesday, October 25, 2006 Ulrich Von Andrian videocast.nih.gov/PastEvents.asp?c=28
    He has also been invited to speak at the Keystone Symposia being organized this year by the NCI’s Dr. Restifo. www.keystonesymposia.org/Meetings/Vie...
    
    5. The second “agent” of change might include John Hopkins’ Dr Elizabeth Jaffee, one of the authors of a Review Article: Leveraging the Activity of Tumor Vaccines with Cytotoxic Chemotherapy Cancer Research 65, 8059-8064, September 15, 2005 cancerres.aacrjournals.org/cgi/conten... Dr. Jaffee has been asked to give a presentation on “Tipping the Immune System Balance in Favor of Effective Anti-Cancer Therapy” on January 25, 2007 at a conference being oranized by the Lee Moffitt Cancer Center & Research Institute, and in which Dr. J. Mulé, Ph.D. of Moffitt, will be a Chair of a discussion of Antigen Presenting Cells & Immune Suppression: Mechanisms of T-cell Non-Responsiveness. Dr. Mule’ is also the Chair of CBER’s Cellular, Tissue and Gene Therapy Advisory Committee, to which DNDN is expected to present Provenge in March. He also interned at the NCI in the late 1970's under Dr. Rosenberg and is an Editor of the Journal of Immunotherapy, where Dr, Rosenberg is Chief Editor. www.moffitt.usf.edu/Site.aspx?spid=62... Dr. Jaffee has also been invited to speak at the FDA/NCI workshop on therapeutic vaccines on 2/8/07. cms.palladianpartners.com/cms/1156354...
    The Video webcast will be through: videocast.nih.gov/FutureEvents.asp
    
    6. Putting it all into context: (a) Dr. Daniel Petrylak, an expert on Taxotere in AIPC/HRPC reported in November that prior Provenge therapy before Taxotere in AIPC dramatically increases median survival beyonf that expected of either alone; (b) DNDN also reported in November that the P-11 trial immune monitoring in ADPC showed that median T cell proliferation (Stmulation Index) results were 118.5 at 13 weeks post therapy (vs. 2. 3 in the placebo arm) (p value <0.0001), and some 21 months after Provenge therapy was an astonishing 93.7, which was increased to 221.8 with one booster infusion; (c) Dr. von Andrian explains how dendritic antigen presenting cells matured from peripheral blood monocytes ex vivo are directed to bone marrow after in vivo infusion where they prime particularly effective and durable memory T cells; (d) Dr. Jaffee has been asked to present a comprehensive overview on how chemotherapy can improve the efficacy of cancer vaccines in two venues of importance to Provenge; and (e) Dr. Small reports that the median survival for Provenge treated AIPC patients in the 9901 trial increases from 4.5 months to 5.9 months when compared to a control group of the 1103 reference AIPC patients of the Halabi nomogram study (effectively eliminating the confounding effects of 9901’s placebo crossover), and that median survival in AIPCfurther increases by 11.7 months when only AIPC related causes of death are considered. investor.dendreon.com/downloads/22568...
    
    7. One of the widely accepted paradigms re
15. [verwijderd] 29 december 2006 22:24

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    Specifiek geschreven op wat er op het ogenblik met de koers van Dndn gebeurd, echt Hogeschool Manupilatie, prachtig beschreven in een stukje gericht aan alle retail shorts op investorvillage onder the shakespere-iaanse titel,
    
    To buy or not to buy, that is the question....
    
    quote:
    
    Pretend you are a retail short.
    
    1. If this company refuses to bankrupt on demand, kowtowing to Stevie and the big dog shorts, your retail short position is becoming unbearably questionable.
    
    2. A Priority Review announcement is coming next week (or the following one at the latest). The FDA does not function in a vacuum, and FDA leaders well understand that political pressures are being brought to bear as to almost every decision they make. If the President of the United States doesn't want a priority review to be announced early, then it probably will be held to the last rule-designated day. If the company behind the filing wants the announcement held to the last rule-required day--or possibly to some later day--then I suppose the FDA has leeway to oblige. (Delaying the announcement has no effect on the final approval date since Priority Review merely indicates that the FDA decsion date will be 6 months from the day last month that the BLA filing was completed and in FDA hands.
    
    3. Someone today said there is a precedent for it to be held for 75 days instead of the rule-prescribed 60 working days. I am inclined to assume this was delayed at the filing company's request (but there are other possible reasons not known to me which also would be conjecture). If ever it has gone 75 days, then I suppose it again could be shoved out, but, again, the announcement date is of no import--only the fact of the announcement is important.
    
    4. Tuesday is now not a working day for the stock market OR Federal employees (presumably). This effectively shoves the 60th day out another day IMO.
    
    5. So what should a good short do? Can the hedgies run it back after the announcement into the mid- or low-threes? It has been to the mid-$3s earlier this year and like an idiot you didn't cover your short position. Would you cover this time? (Yes or No?) If not, when?
    
    6. Suppose it flies on the announcement and never returns to the low $4s? Are you going to be an idiot again? Suppose the MMs suspend trading and re-open in the teens? Could they DO that? If the important shorts have been quietly building long positions on the side for the entire past year and are now ready to let such an event occur, where does that leave you? If the important shorts now hold twice as many long shares as they do short shares, then they could benefit mightily by having the price rise to a point above their highest shorted price in the mid $16s.
    
    7. How is that a benefit to the shorts, you ask? Well, they could then cover the entire short position (and run the price to $45 in the process and book huge realized losses that will offset future 2007 realized profits for tax purposes, and make huge money doing it. Imagine all that profit realized tax free(! ) as they sell a small fraction of their holding into the rally above $17 and they then can use their long position as a long-term hedge when they again sell short in earnest in the $60s and further manipulate this baby to their heart's content. As a silly retail short, how will you handle all this manipulation when it goes against you?
    
    8. Gee! Should you cover your short this afternoon while there is still time to do so advantageously?
    
    9. Naaaww...we already know you are an idiot because you didn't cover and go away like many others did when you had the chance months ago in the $3s.
    
    10. Stay the course, ol" buddy. It's the only way to go. The creditors will bankrupt DNDN sometime soon. Oh, yeah, you forgot for a minute that DNDN doesn't have any creditors--almost forgot about that (all they have is assets and money), but UBS/SAC/BigPharma et al will save your bacon. Right? Suuurre they will ol' buddy! We all know that the big lions in this pasture are vegetarians. Right? They haven't been loading up with off-shore long positions this past year in the $4s and $3s. Right?
    
    11. Right!
    
    12. To buy or not to buy (to cover), that is the question...
    
    e.o. quote
    leo s
    
16. [verwijderd] 30 december 2006 15:51

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    Wat denken jullie,komt die priority review,komende week of eind januari??
    
    RB
17. [verwijderd] 30 december 2006 18:47

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    quote:

    snor13854 schreef:

    Wat denken jullie,komt die priority review,komende week of eind januari??
    
    RB
    

    ik verwacht hem voor half jan
    normaal 60 dagen na completion filing
18. [verwijderd] 31 december 2006 18:59

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    Dat zou een mooi begin 2007 kunnen worden,evenzowel allen een voortreffelijk 2007.
    En vooral gezond.
    
    MVG RB
19. [verwijderd] 3 januari 2007 21:18

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    Hoe is het,nog iemand geinteresseerd in DNDN??
    Inkopen,of extra) worden heel interessant,met het oog op de komende Amerikaanse markt.
    Een koopje zou ik zeggen.
    
    RB
20. [verwijderd] 4 januari 2007 09:54

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    Ja hoor snor, het is nu na crucell mijn het grootste aandeel in mijn portefeuille.
    Het is fantastisch hoe er gevochten wordt met de shorts en änalisten en zal blijven. Alles valt en staat met de FDA goedkeuring, een ja of nee uiterlijk 15 mei a.s.
    Tussendoor een aantal heel belangrijke dagen waarop een idee gekregen kan worden of zelfs het al duidelijk kan worden waar het heen gaat, zijn 8 feb. als de nieuwe directeur van de FDA (zelf een prostaat kanker figuur) een rede gaat houden, 27/28 feb, of 27/28 maart, als er panel bijkomsten zijn waarbij de FDA een panel een oordeel zou kunnen laten vellen ipv het zelf te doen. Komt er geen priority review volgende week dan zou het 11 augustus kunnen worden voordat goed of afkeuring wordt bekend geemaakt. Op zich is priority review niet verschrikkelijk belangrijk, behalve dat het het tijdschema van de FDA beinvloed waarop ze duidelijkheid moeten verschaffen
    Is er geen goed keuring voor die tijd (testen niet voldoende compleet geacht) en de proeven 902b moeten worden overgedaan dan wordt het eind 2008,
    De veiligheid van het middel is ondertussen goed bevonden, de mensen leven er een stuk langer door, maar het ""genezen" is statistisch niet echt aangetoond.
    Ongeveer dezelfde tijd gaat satraplatin door de FDA molen. ( Die op platina gebaseerde pil van de duitse CGP, waarvan de koers alsmaar stijgt ). Erg spannend, vooral omdat je stuitende staaltjes van misleiding en sharedumping door hedgefunds kunt gaan verwachten.
21. [verwijderd] 5 januari 2007 16:19

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    quote:

    snor13854 schreef:

    Wat denken jullie,komt die priority review,komende week of eind januari??
    
    RB
    

    buurt van 12 januari om precies te zijn!
    
    This also will be a busy year for Dendreon, as the Food and Drug Administration begins its review of the company's experimental prostate cancer vaccine, Provenge. On or about Jan. 12, Dendreon should hear whether the Provenge application was accepted and whether it will be granted a priority (six-month) review.
    
    If so, the next big event likely will be an FDA advisory panel meeting to discuss the Provenge clinical data. You might see such a panel scheduled in March or April.
    
    Groet,
    OMG
    
    PS
    To date, investors -- and many prostate cancer doctors -- have been skeptical about Provenge's chances for FDA approval. The biggest hang-up: While efficacy data suggest that Provenge can prolong survival of men with advanced, hormone-refractory prostate cancer, the clinical data generated so far is a bit sparse. Still, there is ample room for debate over this issue, which should make the advisory panel a certain highlight for biotech investors this year