Ontvang nu dagelijks onze kooptips!

word abonnee
IEX 25 jaar desktop iconMarkt Monitor

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,770   +0,000   (+0,07%) Dagrange 0,769 - 0,793 3.496.790   Gem. (3M) 5M

Pharming het aandeel van 2017

50.750 Posts
Pagina: «« 1 ... 1876 1877 1878 1879 1880 ... 2538 »» | Laatste | Omlaag ↓
  1. [verwijderd] 5 oktober 2017 17:03
    quote:

    Biotech-kenner schreef op 5 oktober 2017 16:50:

    From HAEA President Tony Castaldo
    Cinryze Shipments Resume

    The HAEA has confirmed that Shire will be shipping CINRYZE to specialty pharmacies over the next few days.

    Today, patients and physicians will receive letters from Shire with information on the Cinryze “lots” being shipped. The company reports that the water system associated with the manufacturing of these lots was not working properly and created a “possible risk” that small metal particles may be present in the product.

    Before deciding to release this medicine, Shire worked closely with the FDA and conducted an extensive investigation that included visual inspection and opening a sample of vials for specific testing. While the inspection and testing did not reveal the presence of metal fragments, out of an abundance of caution, Shire advises that patients using these “lots” of medicine use an additional filter prior to each administration to. “…mitigate the possible risk of small metal particles being administered.” The filter, along with instructions, will be included in materials that are shipped with the medication.

    The HAEA advises that Cinryze patients discuss this information with their prescribing physician.

    The manufacturing problem has been fixed and production of Cinryze has resumed.

    We are in touch with Shire and will provide additional information to the patient community as it becomes available.
    Dus Shire gaat de lot die geproduceerd is releasen, met mogelijke contaminatie met metalen deeltjes. Dat betekend:
    Er is nog geen nieuwe batch geproduceerd, anders zou men hiertoe niet besluiten
    -dat men een groot risico wel moet nemen, nood breekt wet, de vraag is of de patienten dit risico wensen te nemen.
    -dat de kwaliteit van de medicati, en de reputatie van cinryze, niet al te best is. Wat is het volgende wat er mis is...De kwaliteitscontrole laat op zijn best gezegd serieus te wensen over.

  2. [verwijderd] 5 oktober 2017 17:05
    quote:

    moneymaker_BX schreef op 5 oktober 2017 17:00:

    Moet de FDA Cinryze in het zadel houden of zo
    Jeetje stap allemaal over op Ruconest en geeft een aanbeveling richting Pharming
    Gaan we over de hoofden van patienten nog spelen met eigenbelangen
    Denk dat de mannen van de FDA hun aandelen nog moeten verkopen alvorens ze Cinryze af kunnen schrijven
  3. [verwijderd] 5 oktober 2017 17:12
    quote:

    Madebeliefje schreef op 5 oktober 2017 17:03:

    [...]

    Dus Shire gaat de lot die geproduceerd is releasen, met mogelijke contaminatie met metalen deeltjes. Dat betekend:
    Er is nog geen nieuwe batch geproduceerd, anders zou men hiertoe niet besluiten
    -dat men een groot risico wel moet nemen, nood breekt wet, de vraag is of de patienten dit risico wensen te nemen.
    -dat de kwaliteit van de medicati, en de reputatie van cinryze, niet al te best is. Wat is het volgende wat er mis is...De kwaliteitscontrole laat op zijn best gezegd serieus te wensen over.

    Als dat waar is , zou dat heel erg dom zijn. Wat een risico Cyrinze het uitstervend medicijn niet alleen in productie, maar maakt je ziek ipv beter..... lastig dit!
  4. [verwijderd] 5 oktober 2017 17:12
    quote:

    Biotech-kenner schreef op 5 oktober 2017 16:50:

    From HAEA President Tony Castaldo
    Cinryze Shipments Resume

    The HAEA has confirmed that Shire will be shipping CINRYZE to specialty pharmacies over the next few days.

    Today, patients and physicians will receive letters from Shire with information on the Cinryze “lots” being shipped. The company reports that the water system associated with the manufacturing of these lots was not working properly and created a “possible risk” that small metal particles may be present in the product.

    Before deciding to release this medicine, Shire worked closely with the FDA and conducted an extensive investigation that included visual inspection and opening a sample of vials for specific testing. While the inspection and testing did not reveal the presence of metal fragments, out of an abundance of caution, Shire advises that patients using these “lots” of medicine use an additional filter prior to each administration to. “…mitigate the possible risk of small metal particles being administered.” The filter, along with instructions, will be included in materials that are shipped with the medication.

    The HAEA advises that Cinryze patients discuss this information with their prescribing physician.

    The manufacturing problem has been fixed and production of Cinryze has resumed.

    We are in touch with Shire and will provide additional information to the patient community as it becomes available.
    Een goede response voor de slapers hier - AB
  5. [verwijderd] 5 oktober 2017 17:13
    quote:

    moneymaker_BX schreef op 5 oktober 2017 17:06:

    Prutswerk van Shire
    Waarom niet gewoon een veilig RUCONEST zonder metaaltjes en zonder kans op
    besmet bloed
    Wat een overloos gelul en waarom komt die FDA niet gewoon OVER DXE BRUG met aanbeveling Ruconest
    Niemand kan er meer om heen
    Van de zotte dit
    Dit geeft aan hoeveel betekenis Pharming heeft voor de FDA.
    Geen ene kloten, dus mensen, dumpen die handel :-)

    Koop ik ze wel !
    Hahaha

    Mensen, wat een verschrikkelijk dom gelul hier zeg....
  6. [verwijderd] 5 oktober 2017 17:21
    quote:

    tKanVriezenEnDooien schreef op 5 oktober 2017 16:55:

    [...]

    Ik volg de berichten van de hoogste instanties:

    www.ema.europa.eu/ema/index.jsp?curl=...

    www.fda.gov/biologicsbloodvaccines/sa...

    Maar ze zullen wel weer gaan produceren hoor. Maar niet genoeg om de markt te voorzien nu en de verder groeiende markt. Plasma problemen blijven.

    Niet alleen plasma er is ook een tekort aan bloed zoals enige dagen terug werd aangegeven. Operaties werden hierdoor uitgesteld, nee bloed heeft niet de toekomst.

  7. [verwijderd] 5 oktober 2017 17:26
    quote:

    maliqun61 schreef op 5 oktober 2017 09:43:

    [...]

    Pas bij uitbreiding van het geplaatst kapitaal van >1% (heb je mij zelf geleerd). Dus pas bij omwisseling van minimaal 5.000.000 warrants (of converteerbare obligaties/notes). Er gebeurt wel wat, maar mondjesmaat:
    Opgave door Pharming dd 10 aug 2017: shares issued 517,674,026
    AFM meldt op 30 september: van 508.073.187 via 518.158.502 naar 520.067.352.

    OTC-handel maandag en dinsdag: ca 1.000.000 stuks.

    Zie hieronder een toelichting die ik terug heb gelezen uit het annual report 2016:

    Equity
    The Company only has ordinary shares and these are classi- ed within equity upon issue. Shares transferred in relation to settlement of (convertible) debt and derivative nancial liabilities are measured at fair value with fair value based on the closing price of the shares on the trading day prior to the settlement date. Equity is recognized upon the issue of xed warrants with a xed exercise price as well as upon the recognition of share-based payment expenses; shares issued upon exercise of such warrants or options are measured at their exercise price.
    Transaction costs associated with an equity transaction are accounted for as a deduction from equity to the extent they are incremental costs directly attributable to the equity transaction that otherwise would have been avoided. Trans- action costs related to the issue of a compound nancial instrument are allocated to the liability and equity compo- nents of the instruments in proportion to the allocation of proceeds.

    verder:
    Derivative instruments presented as nancial liabilities
    Derivative instruments which are not equity instruments under IAS 32, IAS 39 and IFRS 13 and other standards, such as warrants to acquire Pharming shares which have a cashless exercise option and the conversion option for repayment of the instalments into shares, are presented as nancial liabilities.
    All Pharming warrants are essentially the commitment to is- sue a xed number of shares for a xed amount of cash, but the possibility of cashless exercise (where a holder decides to accept fewer shares so as to avoid paying the relevant amount of cash, thus resulting in a number of shares to issued which can vary downward from the original number) requires that such warrants are treated as nancial liabilities. As such, these derivative instruments are initially recognized at fair value and subsequently revalued at fair value through pro t or loss with changes in the fair value recognized in the statement of income as they arise. Such revaluations
    do not represent the actual liability to issue shares, which is unchanged, but a notional market value of the instrument as if a new instrument with the same terms were issued on the measurement date. The revaluations are not cash move- ments or capable of being realized, and any accumulated revaluation total is returned to the pro t & loss account (if a loss) or added to equity (if a gain) upon the extinction of the instrument through exercise or expiry, resulting in a net nil balance. These revaluation amounts do not represent any aspect of the performance of Pharming as a company, and are accordingly presented as a separate line under Financial Income and Expenditure.
    As at 31 December 2016, the Company has presented such derivative instruments as nancial liabilities with a carrying value of €10.0 million. The revaluation shown in the pro t & loss account represents the notional adjustment necessary to re ect the market values of similar warrant rights as if they were issued on the measurement date (31 December 2016) with the same terms and are based on models using assumptions with respect to, inter alia, the exercise of the warrants on or before maturity dates as well as (histori- cal) volatility. Actual share price developments may trigger
    exercise of these warrants at a di erent time than assumed in the model, or result in their expiry unexercised, and may also result in the issue of shares to warrant holders at a time when the Pharming share price is higher or lower than anticipated at 31 December 2016. As a result, the di erence between the open market value of shares transferred to warrant holders upon exercise and the carrying value at year-end 2016 as charged to the statement of income may be material, but will be a non-cash movement to pro t & loss or equity as described above.
    A sensitivity analysis on the possible e ects has been inclu- ded in note 30 of these consolidated nancial statements.

    Ik moet nog controleren wat er bij note 30 staat over de possible e ects......

    Conclusie tot op heden. Het zou volume van een dag kunnen verklaren maar niet de lagere koers. Effect op koers lijkt mij nihil, omdat ze reeds geregistreerd zijn tegen de uitgifte prijs bij uitgifte en naar de waarde van de aandelen bij sluit op de voorgaande dag worden geëffectueerd.

    Ik was met Voda al aan het uitdokteren van de journaalpost. Maar we gaan nog even door. Iemand met vergaande kennis van warrants?
50.750 Posts
Pagina: «« 1 ... 1876 1877 1878 1879 1880 ... 2538 »» | Laatste |Omhoog ↑