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NPS Pharmaceuticals - NPSP

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  1. [verwijderd] 8 maart 2006 21:05
    NPS Pharmaceuticals - RT $14.04
    finance.yahoo.com/q?s=npsp

    NPSP…1 dag voordat de FDA, naar het zich laat aanzien, PREOS (PREOS ® is our brand name for recombinant, full-length human parathyroid hormone which we are developing as a potential treatment for post-menopausal osteoporosis. ) voor de Amerikaanse markt goed zal keuren.
    Inmiddels heeft de CHMP op 22 februari al de Europese goedkeuring gegeven!

    (..)In May 2005, we filed a New Drug Application or NDA, with the FDA seeking approval to market PREOS ® in the U.S. The PDUFA date for the PREOS ® NDA is March 10, 2006. “PDUFA date” refers to the date that the FDA is expected to notify a drug sponsor about the approval status of an NDA. We have granted to Nycomed Danmark ApS, or Nycomed, the exclusive right to market and sell PREOS ® in Europe. Nycomed also assumed responsibility to file all necessary regulatory filings to obtain marketing approval for PREOS ® in Europe. Nycomed filed its European marketing authorization application, or MAA, with the European Medicines Evaluation Authority, or EMEA, in March 2005. The Committee for Medicinal Products for Human Use of the EMEA, or the CHMP, has adopted a positive opinion recommending authorization for Nycomed to market PREOS ® in Europe. The CHMP recommendation is generally the last step prior to receipt of marketing authorization by the EMEA. If marketing approval from the EMEA is granted, Nycomed intends to market PREOS ® in Europe under the brand name PREOTACT ® and expects to be ready to launch PREOTACT ® in Europe during the second half of 2006.
    tinyurl.com/gtfue

    De markt alleen voor PREOS wordt geschat op zo’n: $ 18 billion
    (…)The consequences of osteoporotic fractures can be devastating, potentially resulting in pain, disfigurement, disability and death. Additionally, the costs associated with osteoporosis and osteoporosis related fractures are significant. In the United States alone, expenditures for osteoporosis and related fractures in 2002 were estimated at $18.0 billion, and rising.(…)

    Van de 41 mio uitstaande aandelen zijn er 91.8% (!!!!) ondergebracht bij IB’ers en 4.8% bij insiders! Dat betekent dus dat er een zeer kleine float aandelen zijn, te weten 1.4 mio aandelen, thans vrij verhandelbaar op de markt (3.4%) !!!
    tinyurl.com/krsq3

    Vind meer info in het gedegen analisten rapport van November door Jeffries :
    www.knobias.com/research.pdf?id=2156

    Aantrekkelijke pipeline en aantrekkelijke partners:
    www.npsp.com/drug_development/pipelin...

    Vandaag aangekocht op $14,30. Natuurlijk bestaat de kans dat de FDA het niet goed keurt, maar met de CHMP in de broekzak, additionele FDA-vragen beantwoord, lijkt mij die kans bijzonder klein. Heb in ieder geval het ‘risico’ genomen.

    Geluk, F.

    PS ...En gepost voor de FDA - Approval, zo kan eenieder zelf uitmaken hoe risicovol hij/zij wil handelen!
  2. [verwijderd] 8 maart 2006 22:29
    RT: 14.25 Up 0.18 (1.28%

    quote:

    Stimpy1126 schreef:

    wat zou koerspotentieel zijn voor daytrade? enig idee? MVG
    ...Salt Lake City-based NPS has an experimental drug called Preos that builds bone strength and could achieve $1 billion in sales in five years, Isaly says.
    "We expect this to be the market leader," he adds, "not only in the United States but worldwide."
    NPS has a long way to go before that. Preos isn't likely to win Food and Drug Administration approval until late 2005, Isaly notes. But he predicts that Preos can surpass Eli Lilly's Forteo, a rival treatment with a couple of years' head start.
    If Preos lives up to its promise, NPS Pharmaceuticals could build stronger bones itself.

    The drug could make the company profitable and lure investors to the stock, Isaly says. Riding the Preos wave, NPS's market value, now at about $660 million, could grow to $5 billion by the end of the decade, he adds.
    tinyurl.com/oxfmb

    ...En nu 46 mio aandelen uitstaande...simpele rekensom leert ons dan dat de verwachtingswaarde van't aandeel erg hoog kan worden, te weten...
    $1 billion / 46 mio = $ 21.75 revenue / share
    Bio - Multiplicator op revenue is ongeveer 3.5 (conservatief) levert je dus een te verwachten PPS op van $76,00 (in 5 jaar).
    ...Wat dit nu precies zal doen voor een daytrade na FDA-approval...Ik heb geen idee. Wel weet ik dat de markt groeiende is; vergrijzing!

    Geluk, F.

    PS..$1 Billion pakken op'n markt van $18 Billion vind ik erg conservatief=> dus veilig!
  3. [verwijderd] 8 maart 2006 23:26
    After Hours (RT-ECN): $15.00 Up 0.75 (5.26%)

    NPS Pharma May Reach Profitability By 2009
    David Ng, 02.17.06, 9:15 AM ET

    NPS Pharmaceutical could swing to profitability by 2009, assuming that its costs come under control by 2007.

    That's the view of Standard & Poor's Equity Research analyst Frank DiLorenzo, who reiterated a "hold" rating and $17 target price on the drug company.

    The analyst expects NPS (nasdaq: NPSP - news - people ) to receive approval for its osteoporosis treatment Preos from the U.S. Food and Drug Administration some time in March, but warned of a slow launch due to competition from Forteo from Eli Lilly (nyse: LLY - news - people ).

    "We think peak annual Preos sales could reach $250 million in the U.S. by 2012," the analyst wrote in a recent investor note.

    Yesterday, NPS posted a fourth-quarter loss per share of 96 cents, which was a nickel narrower than the analyst's estimate. In the year-ago period, the drug maker reported a loss of $1.34 per share.
    tinyurl.com/qphu6

    ...De nummers hier zijn conservatiever dan in voorgaande artikelen!
    ...Op basis van de hier genoemde nummers zou je op een verwachtingswaarde PPS komen van ($250 mio / 46 mio) * 3.5 = $19.02. Alleen met Preos gerekend!

    Geluk, F.

    PS...De FDA blijft natuurlijk het laatste woord hebben, hoewel de schijnbare zekerheid van deze analyst, vrolijk stemt!

  4. [verwijderd] 10 maart 2006 10:40
    ...Nog even ter herinnering, vandaag gaat immers bekend worden of PREOS (markt geschat op $18 billion; NPSP-share geschat tussen $250 mio-$1 billion), FDA-approval krijgt! Inmiddels hebben ze al CHMP goedkeuring gekregen op 22 Februari.
    ...Vind onderstaand links die holdings weergeven; op het aantal uitstaande aandelen van 46 mio is 'slechts' 5% vrij verhandelbaar op de markt. Rest in handen van insiders & institutionals!!

    tinyurl.com/krsq3
    tinyurl.com/mqb76
    tinyurl.com/rz5mw

    ...De koers is blijven schommelen rond $14....Nog geen additionele nieuwsfeiten bekend!
    finance.yahoo.com/q?s=npsp

    Op'n mooie dag!

    Geluk, F.

    PS Bij niet goedkeuring wordt er waarschijnlijk terug gevallen naar de $8-$10 range; er is immers nog altijd een mooie pipeline & goedkeuring voor Europa!!.
  5. [verwijderd] 10 maart 2006 16:27
    RT $14.34 Up 0.30 (2.1%)

    Dank Gigant voor beide grafieken!

    ...Nog geen nieuws van't FDA - front! Wel een interessant artikel in the Motley Fool over NPSP, de groeiende markt en haar directe concurenten!
    tinyurl.com/afvek

    (...)NPS shareholders, looking forward to Preos revenues in the first half of 2006, have long been waiting for this event. The filing had been delayed for several months as NPS worked through some technical issue with the voluminous application package, but management now says all its ducks are in a row.

    If approved, Preos will compete directly with Eli Lilly's (NYSE: LLY) Forteo, a closely related PTH fragment that brought in sales of $239 million in 2004, its second year on the market. Is now a good time to consider an investment in NPS -- or, for that matter, one of several other companies working on new osteoporosis drugs?

    The large osteoporosis treatment market is growing, and as the population ages, it will likely continue to expand for years to come. By 2010, the market for osteoporosis drugs is expected to grow to around $10 billion. Some studies suggest there could be even larger growth potential because the disease often goes undiagnosed(...)

    ...In afwachting, stijgt de koers nu beetje bij beetje! (overigens wordt ook hier weer een $billionen markt gecalculeerd)

    Geluk, F.
  6. [verwijderd] 10 maart 2006 20:36
    NPS Receives Approvable Letter for PREOS NDA

    SALT LAKE CITY, March 10, 2006 /PRNewswire-FirstCall via COMTEX/ -- NPS Pharmaceuticals, Inc. (NPSP : NPS Pharmaceuticals Inc
    News , chart, profile, more
    Last: 14.26+0.22+1.57%

    NPSP14.26, +0.22, +1.6%) announced today that the U.S. Food and Drug Administration (FDA) has determined that the company's new drug application (NDA) for PREOS(R) (parathyroid hormone [rDNA origin] for injection) is approvable. The FDA indicated that the company's pivotal study with PREOS demonstrated significant fracture risk reductions in postmenopausal women with osteoporosis, but noted the higher incidence of hypercalcemia with PREOS compared to placebo. The agency expressed concern regarding hypercalcemia associated with the proposed daily dose of PREOS and has requested additional clinical information. The agency also requested additional information regarding the reliability and use of the injection device for delivery of the drug.
    NPS has requested a meeting with the FDA to address these issues and to determine whether existing data are sufficient to respond to the agency's concerns or whether additional studies will be required. Subsequent to these discussions, NPS will be better able to project the timing for approval and launch of PREOS. tinyurl.com/nawgn

    ...Handel is stilgelegd! Ik verwacht dat deze pas weer maandag zal aanvangen!

    Geluk, F.
  7. [verwijderd] 10 maart 2006 21:08
    ...Handel toch voortgezet om 15:00.

    ...Approvable leter niet goed ontvangen! Markt reageert heftig -$4.5. Prijs nu rond $9.50.
    ...Ben benieuwd of er enige rationaliteit in de koers is gekropen op maandag! Vandaag zal dit niet meer gebeuren!

    Geluk, F.
    tinyurl.com/nta46
    NPS says US FDA deems osteoporosis drug approvable
    Fri Mar 10, 2006 2:50 PM ET

    NEW YORK, March 10 (Reuters) - NPS Pharmaceuticals Inc. (NPSP.O: Quote, Profile, Research) on Friday said U.S. regulators deemed its osteoporosis drug approvable, pending the company providing more clinical data and information regarding the reliability and use of the product's injection device.

    NPS said it has requested a meeting with the Food and Drug Administration to address the issues with its Preos drug, and to determine whether additional studies will be required in order to gain marketing approval for the product.
  8. [verwijderd] 10 maart 2006 21:13
    Koers gevallen naar 9 usd; opleving naar 10. Zal volgende week weer verder zakken naar 9. Zelfde patroon zoals we dat ook GTCB telkens zien.

    print.chartnet.nl/Show.cgi?Img=11D5C3...

    Triest he !

    Lessons learned:
    Koers stijgt op de fantasie en vlak vóór goedkeuring er (even) uit. Daarna alle warrants laten executeren en dan er weer in.
  9. [verwijderd] 13 maart 2006 17:13
    RT $9.10 Up $0.33 (3.76%)

    ...Wonden likkend en langzaam opkrabbelend! Inmiddels hebben 4 Institutionals hun mening ook gegeven; 'Oversold' is de algemene reactie op deze approvable letter.

    March 13, 2006
    08:09 EDT NPSP theflyonthewall.com: NPS Pharma-NPSP weakness overdone on Preos, reit Buy@SBSH
    The firm believes NPSP has enough clinical data to address FDA concerns for Preos. :theflyonthewall.com

    07:37 EDT NPSP theflyonthewall.com: NPS Pharma-NPSP weakness on Preos delay overdone, reit Overweight@LEHM
    The firm remains confident in Preos' therapeutic profile and ultimate approvability. Target to $14 from $17. :theflyonthewall.com

    07:22 EDT NPSP theflyonthewall.com: NPS Pharma-NPSP 38% sell-off is an overreaction, reit Buy@JEFF
    While Jefferies considers the Preos approvable letter disappointing they consider the 38% sell-off an overreaction. :theflyonthewall.com

    Susquehanna believes there is a 60% probability of outright approval, with stock then increasing to approx $17.50; 30% probability of an approvable letter, with stock then decreasing to approx $12.50; and a 10% probability of outright rejection, with stock then decreasing to approx $7.

    ...PPS zal, afgaande op bovenstaande, snel herstellen naar een range van $12.5-$15. Wanneer dit zal zijn, zal sterk beinvloed worden door de 'meeting' die NPSP-management heeft met de FDA. Alleen al de bekendmaking van de datum van deze meeting zal de PPS weer verder doen stijgen!
    ...'t Blijft even afwachten...helaas!

    Toch...

    Geluk, F.
  10. [verwijderd] 13 maart 2006 18:30
    RT $9.47 Up $0.70 (8.0%)

    ...Inmiddels is de weg omhoog teruggevonden en worden adviezen van analisten gretig ter hand genomen! Volume is inmiddels over 4 mio en institutional trading is meer dan 21% (bijna geen MM's).
    tinyurl.com/nwzey

    ...Zou't herstel zich dan toch al vandaag aanmelden?

    Geluk, F.

  11. [verwijderd] 30 maart 2006 13:17
    RT: On Mar 29: $8.79

    ...NPSP geeft openheid van zaken naar aanleiding van 'approvable letter'; zal PPS vandaag even een vluvht geven!
    ...Geplande afspraak met FDA op 1 Mei. Voorbeurs goed in de gaten houden! Kan makkelijk 10% stijgen bij deze lage koers (die overigens sinds approvable letter zo rond de $8.75 - $9 schommelt)

    NPS Updates Status of PREOS(R) NDA
    Wednesday March 29, 7:26 pm ET

    SALT LAKE CITY, March 29 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) today provided the following update regarding the status of its new drug application (NDA) for PREOS® (parathyroid hormone [rDNA origin] for injection).

    Since receiving an approvable letter from the U.S. Food and Drug Administration (FDA) for the PREOS NDA on March 9, 2006, NPS has been in communication with the FDA by telephone and in writing regarding the issues raised in the approvable letter.(...)

    (...)NPS believes that the analyses it is supplying to the FDA should form the basis for a Class 1 resubmission, which under the Prescription Drug User Fee Act would be considered a minor re-analysis and clarification of existing data and would commit the FDA to a two-month review period upon receipt of the completed resubmission. However, the company emphasizes that the FDA will determine whether the information NPS provides in response to the approvable letter will qualify as a Class 1 resubmission. The agency might also require a resubmission which would involve significant new data, including a new clinical trial, which would constitute a Class 2 resubmission.
    tinyurl.com/lfhyu

    Geluk, F.
  12. [verwijderd] 3 mei 2006 20:46
    NPS Pharmaceuticals (NPSP : NPS Pharmaceuticals Inc
    News , chart, profile, more
    Last: 5.22-2.99-36.42%

    2:29pm 05/03/2006

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    NPSP5.22, -2.99, -36.4%) sank 32% to $5.57. In its quarterly earnings report late Tuesday, the company said that the FDA is seeking additional clinical information for its bone drug candidate Preos, which received an approvable letter from the agency on March 9. The company said it is negotiating with the FDA on alternative ways to obtain that information without running an additional clinical trial.

    www.marketwatch.com/News/
  13. [verwijderd] 31 mei 2006 11:49
    WASHINGTON, May 30 (Reuters) - Soros Fund Management LLC said on Tuesday it now owns 6.8 percent of NPS Pharmaceuticals Inc. (NPSP.O: Quote, Profile, Research), according to a filing with the U.S. Securities and Exchange Commission

    The fund, controlled by billionaire investor George Soros, acquired more than 3.1 million shares over the past 60 days for a total of about $8.9 million, according the filing

    The Soros group is "concerned about...the past and current decision making and operations," of the company and "may suggest strategic changes," the filing said.

    NPS' stock is trading at $5.93 a share in after hours trading after closing at $5.44 on the Nasdaq.

    tinyurl.com/nmbac
  14. [verwijderd] 12 juni 2006 18:18
    Handel stopgezet na aankodiging van grrot reorganisatieplan.

    NPS Announces Aggressive Plan to Restructure Operations and Cut Costs
    Conference Call Scheduled for 2 pm Eastern Time Today
    12:10 PM ET Jun 12, 2006

    PARSIPPANY, N.J., June 12, 2006 /PRNewswire-FirstCall via COMTEX/ -- NPS Pharmaceuticals, Inc. (NPSP : NPS Pharmaceuticals Inc

    NPSP5.50, -0.08, -1.4%) CEO N. Anthony Coles, M.D., announced today a new initiative to maximize shareholder value by significantly reducing cash burn, reprioritizing the company's development portfolio, and leveraging its proprietary R&D assets. To support this initiative, the company is taking the following immediate actions.
    Restructuring to Decrease Cash Burn
    NPS is reducing staff at each of its facilities and discontinuing all activities related to the commercialization of PREOS(R) in the United States. Specifically, NPS is:
    * reducing staff by 53 percent;
    * closing a technical operations facility in Mississauga, Ontario,
    Canada;
    * eliminating commercial sales and related field operations;
    * terminating the company's agreement with Allergan to promote
    Restasis(R) Ophthalmic Emulsion to rheumatologists; and
    * subleasing 50 percent of its Salt Lake City facility; .

    The net effect of these changes reduces the total number of employees to 230. Additionally, the board of directors has reduced director compensation in accordance with these cost cutting measures. As a result of this restructuring, cash burn for 2006 will decrease to approximately $135 million to $145 million. The company expects to end 2006 with two years of cash, with an approximate year-end cash and cash equivalents balance between $114 million and $124 million.

    Dr. Coles stated: "We are taking these measures to reduce operating expenses and preserve cash so we can pursue projects with the highest potential returns and build a stronger and healthier company. These cost saving measures will result in an immediate and significant decrease in spending for the company. We will continue to seek productivity improvements and increased operating efficiencies as we go forward. I regret that these actions require the elimination of roles for many talented people who have made important contributions to NPS and we wish them every success as they leave us."
    Reprioritizing the Development Portfolio

    NPS will focus its clinical development activities on teduglutide, its proprietary potential first-in-class drug candidate for gastrointestinal disorders, and will work to accelerate the drug's development for Crohn's disease and other indications. Patient enrollment for the Short Bowel Syndrome (SBS) trial continues and aggressive efforts will be made to file a new drug application for this indication by 2008.

    Dr. Coles stated: "With our pharmaceutical partners GlaxoSmithKline, AstraZeneca and Janssen making excellent progress in their programs to develop calcilytics, mGluR modulators and glycine transport inhibitors, respectively, multiple NPS-discovered compounds are being advanced through the clinic with development investments by our partners. We have recently announced that the calcilytics program, led by GlaxoSmithKline, is advancing to later-stage clinical studies for the treatment of patients with osteoporosis. With the recent successful completion of a proof-of-concept trial for this compound in healthy post-menopausal women, this program has reached an important risk-reducing milestone. These orally active small molecules may represent an important efficacy and convenience opportunity in the multi-billion dollar osteoporosis market and have the potential to be the first oral anabolic agents for improving bone micro-architecture in this debilitating disease. Additionally, our partner AstraZeneca announced last week that they are conducting ongoing Phase I studies for an mGluR compound, indicating its rapid advancement in the clinic.

    "This partnership model allows us to balance our risk in the discovery and development of novel compounds with a financial contribution from our partners, while retaining valuable downstream co-promotion rights in the case of the calcilytics and mGluR programs. As these partnered compounds advance in the clinic in parallel with NPS-proprietary compounds, this risk-sharing investment model places us in an ideal position to implement an aggressive development plan for teduglutide and focus our resources and efforts on this potential first-in-class compound."
    Maximizing PREOS Value

    Because of the delay in FDA approval of PREOS and the uncertainty regarding the time and expense needed to obtain U.S. approval, NPS is revising its U.S. strategy for PREOS. The company is discontinuing all current commercialization activities for the U.S. launch of PREOS, while evaluating the most appropriate regulatory, development and investment options for bringing PREOS to the market. The company has previously disclosed that the two options it is assessing are the filing of an amendment with data from existing and ongoing studies and the initiation of a new clinical trial to collect additional data to demonstrate the benefit/risk ratio of PREOS.

    Dr. Coles stated: "PREOS is a valuable global asset for NPS. We continue to believe it is an important, effective and well-tolerated treatment for post-menopausal women with osteoporosis. Given the clinically meaningful reduction in vertebral fracture risk demonstrated in the pivotal TOP trial, we believe PREOS deserves to be made available to patients globally as an alternative to existing therapies. Its approval by the EMEA validates its effectiveness in women who desperately need treatment choices. Our partner,

    Nycomed, began the launch of Preotact in Europe last week and will continue launching throughout the rest of the EU over the next year. We intend to support their launch efforts and the commercialization of PREOS outside the United States as we work to address the issues raised in the FDA approvable letter. We continue to anticipate that an amendment to our NDA without a new clinical trial may be sufficient, but if it becomes evident that data from a new trial is necessary for registration, we have decided not to pursue additional trials without a partner to fund that effort."
    Leveraging a Discovery Heritage

    The NPS discovery team is currently working on a series of antiepileptic compounds from which it expects to select a lead candidate for preclinical development by the end of the year. Discovery scientists are also working on earlier-stage proprietary programs in obesity and schizophrenia.
    Dr. Coles noted: "Our ability to discover novel medicines has been validated by the commercial launches of Sensipar(R) and PREOTACT. Our potential first-in-class compound, teduglutide, also provides further evidence of the innovation that has been a key part of our research effort and we look forward to advancing it in development. Additionally, the clinical advances being made with calcilytics, mGluRs and the glycine transport inhibitor program by our development partners give NPS another opportunity to leverage the productivity of our laboratories. We will continue to build on this rich heritage by ensuring that our discovery team has the technology and resources it needs to maintain this high level of productivity."
  15. [verwijderd] 12 juni 2006 18:22
    Vervolg...

    Operating Principles
    The company's guiding principles to support this new initiative will be to manage its cash prudently with a focus on operating efficiency, execution of product development plans to drive toward NDAs and the regular announcement of financial guidance. The company will also ensure that it has the necessary skills and competencies in place to manage this initiative. Consistent with this, NPS has recently announced the addition of several new senior executives with significant industry experience in the fields of regulatory affairs, corporate development, clinical research and market development.

    "This set of experiences is an important enhancement to the existing management team and I am confident that the team we are building has the right capabilities and leadership skills to take NPS to the next level of growth," stated Dr. Coles. "We have been fortunate to attract a top-quality team and now is the time for us to deliver against this initiative."

    Financial Guidance
    The restructuring initiative will reduce 2006 cash burn to between $135 million to $145 million this year. The company expects to end 2006 with two years of cash, with an approximate year-end cash and cash equivalents balance between $114 million and $124 million.
    Dr. Coles concluded: "With two products from our own laboratories already commercialized, two programs in or approaching late-stage clinical development, continued progress in partnered programs and new drug candidates emerging from discovery research, we are demonstrating our ability to bring novel medicines to patients with unmet medical needs. This remains our primary motivation and commitment, and I am very optimistic about what we can achieve in the months and years ahead."

    Upcoming Milestones
    The company plans to reach the following milestones by the end of this
    year:

    * Launch a new clinical development program for teduglutide in Crohn's
    disease
    * Advance one or more partnered products into later-stage clinical
    development
    * Announce the U.S. regulatory strategy for PREOS
    * Identify a lead compound for preclinical development as a potential
    treatment for epilepsy and other neuropsychiatric conditions
    * End the year with approximately $114 million to $124 million in cash

    Conference Call and Webcast Information

    Today's conference call will be held at 2:00 p.m. EDT. To participate, dial 1-866-700-6293 and use passcode 31582671. International callers may dial 617-213-8835 and use the same passcode. In addition, live audio of the call will be webcast and may be accessed on the Investor Relations page, Calendar of Events section of the company's website ( www.npsp.com). Callers may access the event replay by dialing 1-888-286-8010 (with passcode 13850400). A replay for international callers can be accessed with the same passcode at 617-801-6888. Both the webcast and conference call will be archived until June 19, 2006
    tinyurl.com/mtykm

    Geluk, F.
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    7. Cofinimmo Q4-cijfers
    8. Brunel Q4-cijfers
    9. Detailhandelsverkopen januari (VK)
    10. Samengestelde inkoopmanagersindex februari (Fra)
de volitaliteit verwacht indicator betekend: Market moving event/hoge(re) volatiliteit verwacht