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Aandeel Pharming Group AEX:PHARM, NL0010391025

  • 1,185 1 dec 2020 17:35
  • 0,000 (0,00%) Dagrange 1,175 - 1,222
  • 9.526.783 Gem. (3M) 7,1M

8 juli - 12 juli

187 Posts
Pagina: «« 1 2 3 4 5 6 ... 10 »» | Laatste | Omlaag ↓
  1. kammetje 9 juli 2013 20:00
    quote:

    't zal maar gebeuren schreef op 9 juli 2013 19:14:


    niet eerder opgevallen ,toch weer ruim 1 miljoen aandeeltje's erbij ,ze hebben zichzelf uiteraard ook weer wat toebedeeld.
    www.afm.nl/nl/professionals/registers...

    www.afm.nl/nl/professionals/registers...


    Komen er nog meer bij was al bekend maar hoeveel ja ??????????
  2. [verwijderd] 10 juli 2013 09:26
    About Study Results Reporting on ClinicalTrials.gov



    Study Status:
    This study has been completed.

    Study Completion Date:
    March 2013

    Primary Completion Date:
    December 2012 (Final data collection date for primary outcome measure)

    Certification or Request for Extension to Delay Results Received:
    July 2, 2013


    Wat is dit???
  3. forum rang 7 Beur 10 juli 2013 10:38
    quote:

    ~hemeneks schreef op 10 juli 2013 10:00:


    bevestiging dat alle resultaten zijn ontvangen
    Nee dus!
    Dit is een bevestiging dat door Pharming een verzoek tot verder uitstel van overlegging van de studieresultaten is ingediend.

    De redenen? Geen idee, maar ik maak me er niet niet echt druk om.
  4. forum rang 7 Beur 10 juli 2013 11:06
    quote:

    ~hemeneks schreef op 10 juli 2013 10:47:


    wat betekent or??
    certification OR request

    certification for
    or
    request for
    Aha, dan wordt het idd een beetje moeilijk voor je hoor maar "or" betekent in het Nederlands "of" :)

    Om uitstel tot overlegging van de resultaten te verkrijgen dien je OF een certificate in OF een request.

    Maar, mijnheertje Hemeneks, ik heb het even voor u opgezocht:

    www.clinicaltrials.gov/ct2/manage-rec...

    Veel leesplezier ermee heh!
  5. forum rang 7 Beur 10 juli 2013 11:11
    quote:

    RRR schreef op 10 juli 2013 11:03:


    Pharming die een verzoek tot uitstel indient?
    Waarom zou men dit doen?

    Mogelijk omdat Santarus wil pronken met de results? Bv vanavond bij die meeting?

    Een andere reden zou minder leuk zijn...
    Ik weet het ook niet maar maak me er zoals gezegd niet echt druk om.Zie hieronder.

    Delayed Submission of Results
    "A Responsible Party may delay submission of results, until the deadline described below, by submitting a certification (see note) that an Applicable Clinical Trial meets either of the following conditions:
    •The trial reached its Completion Date before the drug, biologic, or device is initially approved, licensed, or cleared by FDA for any use (referred to on ClinicalTrials.gov as "certify initial approval")?Results Deadline: Not later than 30 days after the drug or device is approved, licensed or cleared by the FDA

    •The trial studies a new use of an FDA-approved drug, biologic, or device (that is, a use not included in the labeling) for which the manufacturer of a drug, biologic, or device is the sponsor of the trial and has filed or will file within 1 year an application to FDA for approval or clearance of that use (referred to on ClinicalTrials.gov as "certify new use")?Results Deadline: (1) the earlier of the date that is 30 days after the date: ¦New use of the drug or device is approved, licensed, or cleared by FDA
    ¦FDA issues a letter for the new use of the drug or device, such as a complete response letter
    ¦The application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days;
    or (2) two years after the date a certification is submitted, if none of the events listed above has occurred.

    Note: If a Responsible Party, who is both the sponsor and manufacturer, submits a new use certification this certification must be made with respect to each Applicable Clinical Trial that is required to be submitted in an application or report for licensure, approval, or clearance of the use studied in the clinical trial.

    See the statutory provisions for Delayed Submission of Results With Certification (PDF).

    Extension Request

    The Director of the National Institutes of Health (NIH) may extend the deadline for submission of results information for an Applicable Clinical Trial if the Responsible Party submits a written request that demonstrates good cause for the extension and provides an estimate of the date on which the results information will be submitted. Pending publication is not considered good cause for an extension.

    See the statutory provision for Extensions (PDF).

    Submitting a Certification or Request for Extension for Delayed Submission of Results

    A certification or request for extension is submitted via the Protocol Registration System (PRS). A study must have a ClinicalTrials.gov Identifier (NCT Number) prior to submission of a certification or request for extension. Submission of this certification will facilitate automated identification of trials that are not yet required to submit results.
187 Posts
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