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Mooi instap moment Dendreon

1. jip banaan! 12 december 2006 21:19

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   Vanmiddag een order ingezet op 4.39 Kom net thuis en zie dat ik ze binnen heb. Ben benieuwd wat dat word in januari.
2. [verwijderd] 12 december 2006 21:21

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   quote:

   jip banaan! schreef:

   Vanmiddag een order ingezet op 4.39 Kom net thuis en zie dat ik ze binnen heb. Ben benieuwd wat dat word in januari.
   

   echte resistance rond 5,56
   uptrend intact, echter ook veel shorts/washtrades
   
   priority review nieuws verwacht ik toch voor half januari ivm dodelijke ziekte
   
   4,10 steun
   4,28 ook
   
   4,50 resistance en dan nog een paar.. met grote rond 5,56 dus
3. [verwijderd] 13 december 2006 15:38

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   Ook maar ééns de gok wagen met DNDN zie niet in waarom de FDA een middel met zeer milde bijwerkingen zou onthouden aan de velen die aan prostaatkanker lijden
4. [verwijderd] 13 december 2006 18:15

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   quote:

   delkev schreef:

   Ook maar ééns de gok wagen met DNDN zie niet in waarom de FDA een middel met zeer milde bijwerkingen zou onthouden aan de velen die aan prostaatkanker lijden
   

   Ik zou de goedkeuring van Provenge toch maar niet als vanzelfsprekend beschouwen, er zijn een aantal redenen waarom de FDA een approvable letter zou kunnen afleveren. Er zijn inderdaad argumenten pro onmiddellijke goedkeuring, maar er zijn ook een aantal heel plausibele argumenten pro approvable letter. Het feit dat de koers laag blijft, wijst er IMHO duidelijk op dat de markt niet direct rekent op een goedkeuring zonder meer.
5. [verwijderd] 13 december 2006 18:17

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   quote:

   scholle schreef:

   [quote=delkev]
   Ook maar ééns de gok wagen met DNDN zie niet in waarom de FDA een middel met zeer milde bijwerkingen zou onthouden aan de velen die aan prostaatkanker lijden
   [/quote]
   
   Ik zou de goedkeuring van Provenge toch maar niet als vanzelfsprekend beschouwen, er zijn een aantal redenen waarom de FDA een approvable letter zou kunnen afleveren. Er zijn inderdaad argumenten pro onmiddellijke goedkeuring, maar er zijn ook een aantal heel plausibele argumenten pro approvable letter. Het feit dat de koers laag blijft, wijst er IMHO duidelijk op dat de markt niet direct rekent op een goedkeuring zonder meer.
   

   is systemtiach neergeslagen..
   veel shorts daarom laag
   idd risico's
   maar grote kans priority review
   en stijging richting FDA datum sowieso
6. [verwijderd] 13 december 2006 19:24

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   motley fool
   
   www.fool.com/news/commentary/2006/com...
7. [verwijderd] 13 december 2006 20:53

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   Volgende link biedt m.i. een mooi overzicht van de argumenten contra onmiddellijke goedkeuring:
   
   www.investorshub.com/boards/read_msg....
8. [verwijderd] 13 december 2006 20:55

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   quote:

   scholle schreef:

   Volgende link biedt m.i. een mooi overzicht van de argumenten contra onmiddellijke goedkeuring:
   
   www.investorshub.com/boards/read_msg....
   

   even bij vermelden dat Dew veel short op biotech!!!!!
   
   maar zoals gezegd even los van FDA ruling zal er sowieso een stijging zijn naar nieuws toe
   emissie recent van 9,9mln aandelen zijn ook niet gek
9. [verwijderd] 14 december 2006 11:09

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   quote:

   crackedtooth schreef:

   [quote=scholle]
   Volgende link biedt m.i. een mooi overzicht van de argumenten contra onmiddellijke goedkeuring:
   
   www.investorshub.com/boards/read_msg....
   [/quote]
   
   even bij vermelden dat Dew veel short op biotech!!!!!
   
   maar zoals gezegd even los van FDA ruling zal er sowieso een stijging zijn naar nieuws toe
   emissie recent van 9,9mln aandelen zijn ook niet gek
   

   Crack ik mag aannemen dat je een grote believer bent het blijft natuurlijk een gok alles ligt in handen van FDA
10. [verwijderd] 14 december 2006 13:13

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    Nee, Dew is alleen mbt tot dendreon te negatief tov de risico's
    en heeft in verleden toegegeven meeste te verdienen toen met shorten..
    
    en ik vind data goed ja, maar los daarvan zal je sowieso net als met bv ency een stijging naar evt FDA datum zien
    
    en 1e nieuws zal zijn priority review
    zie niet in hoe dat niet kan aangezien het om prostaatkanker gaat
12. [verwijderd] 15 december 2006 09:05

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    nieuwe CFO die van een 1.8bln company komt
    
    SEATTLE, Dec. 14 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that Gregory T. Schiffman has joined the company as senior vice president and chief financial officer (CFO).
    
    ADVERTISEMENT
    Schiffman joins Dendreon from Affymetrix Inc., where he served as CFO and executive vice president for the last five years. In that position, Schiffman was responsible for finance, tax, treasury, investor relations and information technology. At times, during his tenure at Affymetrix, he has been responsible for procurement, manufacturing, human resources and facilities.
    
    "With over 20 years of operations and management experience, Greg has created and implemented successful financial, compliance and capital market strategies for a range of companies, most recently at Affymetrix," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "His comprehensive experience will be invaluable to us as we progress toward becoming a fully integrated commercial organization."
    
    Prior to Affymetrix, Schiffman was vice president and controller for Applied Biosystems where he managed a 200-person global finance team spanning more than 20 countries. Prior to entering the biotechnology field, he served for over 10 years in various domestic and international divisions of Hewlett Packard, ultimately serving as a divisional manufacturing manager and controller. Prior to Hewlett Packard, Schiffman also held positions at IBM. He currently serves on the board of directors of Nanomix and Venus Medical Technologies.
    
13. [verwijderd] 15 december 2006 18:40

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    binnen 60 dagen na filing BLA beslissing over priority review of niet
    
    dus verwacht dat voor 15jan
    
    option expiratie op 19 jan.. 5,48 is opties minste verlies voor call/put schrijvers
    
14. [verwijderd] 15 december 2006 20:37

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    quote:

    scholle schreef:

    [quote=delkev]
    Ook maar ééns de gok wagen met DNDN zie niet in waarom de FDA een middel met zeer milde bijwerkingen zou onthouden aan de velen die aan prostaatkanker lijden
    [/quote]
    ..... Het feit dat de koers laag blijft, wijst er IMHO duidelijk op dat de markt niet direct rekent op een goedkeuring zonder meer.
    

    In dit geval volg ik de visie van Soros dan maar: de markt zit altijd fout.
15. [verwijderd] 15 december 2006 23:32

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    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 21594 by rdh19869
    
    Re: A quick? look at Provenge's Clinical Trial History
    1. Phase 2 Immune Monitoring and Cell Count: “The T cell proliferation to the fusion protein were maximal after either two or three infusions of Provenge. For the cohort of 12 patients , the response was significantly higher at week 4 compared with week 0 (p<.01), and at week 8 compared to week 4 (p<.05), but not at week 12 compared with week 8. The dose of Provenge infused did not correlate with the magnitude of T cell response.” at p 3898. “The relationship between the development of a T cell or B cell immune response to PAP (seminal fluid derived) and the time to disease progression was evaluated (Fig. 5). The median time to disease progression was 34 weeks for patients who developed an immune response (n=20) compared to 13 weeks for patients who did not (n=11) (p<0.027).” “The relationship between the time to diseases progression and the average dose of dendritic cells received by each patient was also examined. Inspection of the data revealed that all patients who experienced disease progression more than 24 weeks after registration received average cell doses above 100 x 10 to the sixth cells/infusion. The median time to disease progression was 31.7 weeks for patients who received more than 100 x 10 to the sixth cells/infusion, compared with 12.1 weeks for patients who received fewer cells. (Fig. 6). The difference between the two groups was statistically significant (p=0.013).” at p3899. Provenge Phase 2 Clinical Trial Report: Immunotherapy of Hormone-Refractory Prostate Cancer With Antigen-Loaded Dendritic Cells By Eric J. Small, Paige Fratesi, David M. Reese, George Strang, Reiner Laus, Madhusudan V. Peshwa, Frank H. Valone Journal of Clinical Oncology, Vol 18, Issue 23 (December), 2000: 3894-3903 www.jco.org/cgi/content/full/18/23/3894
    
    2. Phase 3 Immune Monitoring and Cell Count:”Adequate sample collection for immunology testing was avaiable for 49 patients; 18 treated with placebo(40% of total), 31 treated with sipuleucel-T (38% of total). The PA2024 T-cell stimulation index is a measure of specific T cell responsiveness against the target antigen. This exploratory analysis was performed for a subset of patients for whom cells could be processed within 24 hours of collection, thus precluding the need to freeze the cells before analysis. All analyses were performed before study unblinding. The median ratio of the T-cell index at 8 weeks vs. baseline (pre-infusion) was approximately eightfold higher in sipuleucel-T versus placebo treated patients(16.91 Wilcoxon vs. 1.99; Wilcoxon rank sum P<0.001)” at p.3092. “For each of the sipuleucel-T infusions, the number of cells infused was the maximum number of cells that could be prepared from the leukapherisis product; the median number of nucleated cells per infusion was 3.65 x 10 to the ninth and the median number of CD54+ bright cells per infusion was 7.45 x 10 to the eigth.” At p. 3090 Results of a Placebo-Controlled Phase III Trial of Immunotherapy with APC8015for Patients with Hormone Refractory Prostate Cancer (HRPC) E. J. Small, P. F. Schellhammer, C. S. Higano, J. Neumanaitis, F. Valone, R. Hershberg www.asco.org/portal/site/ASCO/menuite...
    61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=34&abstractID=31910
    
    3. Thus, the Ph1/2 T cell proliferation sampling set three as the initial optimal dosing. The potency of Phase 3 Provenge as measured by cell count was far higher than Phase 2, so the Phase 2 data indicated that the TTP endpoint should have been easily statistically significant. The Cumulative CD54 upregulation Provenge potency measure comparing those treated patients above median with those below has now been found to be statistically significant for increased survival. Dr. Provost’s 2/9/06 presentation to the FDA CBER Advisory panel has been updated by the Dendreon Potency Assays Presentation of Poching Liu: www.celltherapysociety.org/files/PDF/...
    
    4. It is ironic that, quoting Dr. Petrylak: "The results of this analysis suggest that the use of PROVENGE as a first-line treatment followed by the chemotherapy docetaxel upon disease progression may provide patients with a substantially prolonged survival benefit." The 9901 and 9902a data suggests that this benefit is far greater than that for either Taxotere or Provenge alone. biz.yahoo.com/prnews/061110/sff019.ht...
    
    5. It is becoming clear that until better adjuvants come along, the unpleasant side effects of chemo have not been dispatched as of yet. One indication of this is that Dr. Elizabeth Jaffee of John Hopkins, the author of a well regarded review of using chemos with vaccines (See: Review Articles Leveraging the Activity of Tumor Vaccines with Cytotoxic Chemotherapy Leisha A. Emens1 and Elizabeth M. Jaffee1,2,3,4 Departments of 1 Oncology, 2 Immunology, 3 Pathology, and 4 Pharmacology, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland Cancer Research 65, 8059-8064, September 15, 2005 cancerres.aacrjournals.org/cgi/conten... ) has been asked to make presentations at both the February FDA/NCI workshop (https://cms.palladianpartners.com/cms/1156354418/home.htm#) and at a Session 1 presentation in a January Immunotherapy Conference prior to Session 2, a series of presentations being moderated by Dr. James Mule’, the Chairman of the FDA CBER Cellular, Gene Therapy and Tisuue Advisory Committee, the panel, which DNDN has indicated will review Provenge in March. See: www.moffitt.org/Site.aspx?spid=621529...
    
    6. The accumulating weight of evidence in immunology is that in spite of the tremendous progress being made with therapeutic cancer vaccines, these therapies still need help in overcoming regulatory T cells and other immunosuppressive effects. Many in the immunology community are urging the FDA to ease the normal oncology eficacy requirements for cancer vaccines given their low side effect profile. See: www.pnas.org/cgi/content/full/103/39/...
    
    7. IMHO, FDA Commissioner Dr. von Eschenbach may use his speech at the February FDA/NCI workshop to reaffirm the importance of using statistically significant measures of clinical benefit, in particular, increased survival, to receive FDA approval of new therapeutic cancer vaccines, potentially citing Dr. Rosenberg’s work at the NCI in melanoma and DNDN’s Provenge’s clinical trial results to show that it can be done, even if presently FDA approved chemos/adjuvants are still required, and with several new ones rapidly progressing through clinical trials to be of future benefit. FDA acceptance of other immunology markers will await additional research and future prospective clinical trials. Most early cancer vaccines may require the use with chemos or other adjuvants to achieve statistical significance in clinical trials until the technology is further improved. All of which, IMHO, simply reaffirms that FDA approval of Provenge, version 1, will set the bar, and will only be the coming attraction for many acts to follow. Sorry for the length, but IMHO, a logical and accurate historical picture
16. [verwijderd] 16 december 2006 12:11

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    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 21699 by dtw1947
    
    Re: A quick? look at Provenge's Clinical Trial History
    dtw1947:
    
    1. So long as clinicians with the stature of Drs. Small and Petrylak. who have examined the underlying data and trial balance speak in support of FDA approval of Provenge, IMHO, there should be no major issues that hold up outright FDA regular approval.
    
    2. The vast majority of clinical immunologists would not expect a cancer vaccine to achieve statistical significance for a near term TTP endpoint, even though the Ph2 Provenge data indicated that that was probable, and, in fact 9901 just missed. The near miss in 9901's TTP should be a non issue.
    
    2. The relatively small 9901 trial size could be raised as an issue, but given the high % of placebos crossing over to Provenge upon TTP, and the availability of a large 1103 Halabi nomogram placebo equivalent data base against which to verify efficacy, that should also be a non issue. The FDA approved Mitoxantrone in 1996 as a palliative in HRPC without any survival benefit on the basis of a small 160 patient Phase 3 trial. In any event, the FDA will require, and DNDN will assure, that 9902b will be fully enrolled for a post marketing Ph4 study to confirm Provenge efficacy using a Cox regression analysis.
    
    3. Valid questions have been raised on this MB about the relative contribution of Provenge and Taxotere as to greatly extended median survival in HRPC, much in excess of the efficacy of either therapy taken alone. As my previous post states, IMO, that will merely add to the logic of approving Provenge alone and allowing the medical community the option of combining the two, using either alone, and/or testing additional combinations in the future. IMO, Sanofi and its Taxotere marketing reps will become big advocates of using Provenge in asymptomatic HRPC in order to position their therapy for more highly efficacious subsequent use. Dr. Small's plots of the survival of 9901 patients who have not received any docetaxel raises the issue as to whether the full 7 month course of Taxotere was required to receive synergistic survival benefits from its use after Provenge, or whether some more limited use might provide a substantial portion of the benefit.
    
    4. Advisory Committee immunologists might ask questions about (a)the impact of regulatory T cells or other immunosuppressive counters to Provenge, (b)related antigens that Provenge might attack through antigen cascade / epitope (determinant) spreading, as well as the loss of Provenge targets and diminished efficacy through antigen loss or escape mechanisms, (c) any relationships between ex vivo post processing CD54 upregulation and subsequent T cell proliferation measured using a treated patient's blood, (d) differences noted between the autologous dendritic cells matured from Peripheral Blood Monocytes ex vivo and dendritic cells recruited in the vicinity of the Ph2 injection of the fusion antigen alone, (e)the balance between effector phase and memory phase T cell priming after Provenge dosing and the ability of the resultant T cells to lyse cancer cells (a CD107a diagnostic test), and (f)the in vivo persistance of Provenge primed T cells and what immunity monitoring yardstick would suggest the need for additional dosing. Although none of these issues should be critical for FDA approval, collectively such information would greatly assist in the intelligent use of Provenge in the clinic.
    
    5. Then, of course, there are Dew's serious concerns: (a) DNDN will never file a BLA, (b)the departure of the prior DNDN CFO's and the absence of a respected DNDN CFO is the "dead canary in Dew's min(d)e, and (c) I sometimes number and sometimes do not number my closing parting wish for DNDN longs. What can one say in the face of such deep and profound analysis?
    
    Good luck to all DNDN longs. Or, 6. Good luck to all DNDN longs.
    
    
    
17. [verwijderd] 16 december 2006 23:29

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    By: walldiver Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 21809 by optimistic skeptic
    
    Re: FDA Process
    9901 overall survival is what DNDN is filing the BLA on, with 9902A being the supportive trial since it was never completed. The question is whether or not the FDA:
    (1) considers 9902A supportive enough
    (2) considers the ttp endpoint less important than the survival endpoint
    
    Provenge has its mild side effect profile going for it. Also, the less successful 9902A trial, in which the survival p value was 0.33, still showed a 3.3-month median survival benefit over the control arm and a ~50% three-year survival benefit over the control arm. The non-stat sig log rank p value in 9902A was more of a function of its smaller trial size and the fact that the pts in the treatment arm were clearly sicker overall.
    
    Taxotere's successful pivotal trial results showed a 2.4-month median survival benefit for the treatment arm. Taxotere's unsuccessful pivotal trial showed virtually no survival benefit.
    
    So, for comparison purposes, Provenge's successful Phase III showed a 4.5-month median survival benefit vs the 2.4-month survival benefit in Taxotere's successful Phase III. Provenge's unsuccessful Phase III showed a 3.3-month MS benefit vs the ~0.2-month MS benefit in Taxotere's unsuccessful Phase III.
    
    Taxotere was approved.
    
    Taxotere's side effect profile is much, much more severe than Provenge's. In fact, it is so severe that 50-60% of asymptomatic AIPC pts refuse Taxotere treatment
    
    
    
18. [verwijderd] 17 december 2006 10:57

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    By: investor_don Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 21794 by bombay_67
    
    Re: FDA Process
    Approval of the manufacturing facility is thought to be an important and challenging part of the new drug approval process. In fact, our management team has made comments to that effect during quarterly conference calls. So where do we stand on the Hanover facility as of December 2006?
    
    1. References: (a) FDA 7346.832 Pre-Approval Inspections/Investigations
    (b) FDA Manual of Standard Operating Procedures and Policies SOPP 8410
    
    Ref (a) is the regulation that specifies when and how the mfg inspection is to be done and how the results will be reported. Chapter 46 is for new drugs. Please note the Ref (a) lists CDER throughout. Ref (b) says that CBER, the agency evaluating Provenge, also uses Ref (a). These can be accessed via the FDA website.
    
    2. Known facts. (a) We were told by management that the Hanover facility was completed and equipped with 12 work stations by mid 2006. (b) Thanks to some great detective work by Jerzee we know that the FDA conducted an inspection of Hanover in mid October and collected samples. This was confirmed by DNDN in the November conference call. Ref (a) spells out what samples have to collected. The company also said that the FDA "validated" the factory. This is very significant if you carefully read Ref (a) and see how it discusses validation. (c) The FDA inspection was conducted by a Field Office - most likely the Philadelphia office. (d) The Field Office inspection team must provide to FDA headquarters one of three recommendations (1) Approval - the Field Office can not give this input in writing to DNDN, (2) conditional approval - an FDA Form 483 must be provided to DNDN before the inspectors leave the facility listing the specific corrections that must be made, or (3) rejection - and the reasons must be provided to DNDN. (e) Per Ref (a) the timing of the FDA inspection at Hanover had to be "triggered" by some event and this could only have been done by the BLA filing on August 24, 2006. By statute, the timing of the inspection must also be compatible with the PDUFA date established by the FDA.
    
    3. My conclusions. If anything but minor problems were found at Hanover by the FDA in October it would have been a material event requiring an 8K notification and there was none. We also know that Hanover was certainly not rejected. As far as we know there was no Form 483 issued or if it was it has been resolved. The company has said that the factory was validated and Ref (a) does not require another inspection before approval. So I conclude that our factory is approved and no other inspections are needed.
    
    It is interesting to me that the submittal of the Clinical and Non-clinical sections of the BLA on August 24th triggered the FDA factory inspection. We submitted the CMC section of the BLA on November 9th and to have done so if there were Form 483 issues unresolved would not make any sense. This suggests that factory issues at Hanover are non-existent, and since this could be a long lead item, we may see an earlier approval date than May 9, 2007.
    
    Best of luck to all longs and Merry Christmas and Happy New Year to all.
    
    
    
19. [verwijderd] 18 december 2006 14:39

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    changewave article
    www.changewave.com/freecontent/2006/1...
20. [verwijderd] 18 december 2006 21:49

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    Shorties aan de wandel vandaag
    
    plukje erbij op 4,16
    
    nog wat cash vrij voor nog een stukje dndn
21. [verwijderd] 18 december 2006 22:14

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    Wie zei er dat er niet door short gemanipuleerd werd?
    Down vandaag.. maar verkopen wel gecovered met call options, er zit nog steeds een grote short positie in dndn
    
    die zullen de prijs laag willen houden tot nieuws priority review uiterlijk 9 januari (maar kan vanaf nu iedere dag) om daarna de nieuws spike onder de 5$ te kunnen cappen
    
    img128.imageshack.us/img128/66/dndnop...