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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,714   +0,043   (+6,33%) Dagrange 0,672 - 0,715 6.351.603   Gem. (3M) 3,2M

Pharming mei 2018

9.480 Posts
Pagina: «« 1 ... 292 293 294 295 296 ... 474 »» | Laatste | Omlaag ↓
  1. [verwijderd] 18 mei 2018 12:13
    quote:

    beeldscherm schreef op 18 mei 2018 11:26:

    FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients

    www.raps.org/news-articles/news-artic...
    ..
    According FDA, sponsors should conduct two randomized placebo-controlled Phase III superiority studies to demonstrate effectiveness if the drug they are testing isn't approved for any other indications, though the agency says that a single Phase III study in combination with other evidence study may be sufficient if the drug has already gone through trials in a closely related indication or if the results of efficacy in a single trial are "highly robust."

    FDA also says the study protocol should specify the type of donors (i.e., donation after brain death, donor after cardiac death or living donor) that will be used, as well as the type of organ recovery, storage, transport conditions and post-transplantation immunosuppressive therapy.

    In addition, FDA says that sponsors should plan on building a preapproval safety database of at least 300 patients, but says that a smaller database may be appropriate "depending on the benefit demonstrated."
    - -
    In the study, Dr. Luis Fernandez of the University of Wisconsin used a non-human primate model to evaluate the outcomes of kidney transplantation from brain dead donors. Kidneys that were treated with rhC1INH prior to transplantation had a significantly lower incidence of delayed graft function (DGF) when transplanted to the recipient animal s. Dr. Fernandez and colleagues were also able to show how rhC1INH inhibited the complement cascade to confer this benefit.

    www.drugs.com/clinical_trials/pharmin...
    Geplaatst om 11:26 bij een koers van 1,26:-)
  2. [verwijderd] 18 mei 2018 12:16
    quote:

    Cor S schreef op 18 mei 2018 12:12:

    [...]

    Lucas, dit is toch niet meer te volgen.... - wat een koers verloop...

    Lol, 't kan 1,51 worden, maar ook 1,15.

    Ik zet wel een laag koopordertje, maar als ie mooi omhoog gaat is het U allen gegeund, wel jammer dat ik net wat te laat was in de lage 1,20.

    Succes en veel wijsheid!
  3. [verwijderd] 18 mei 2018 12:19
    [Quote]

    beeldscherm schreef op 18 mei 2018 om 11:26:

    FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients

    www.raps.org/news-articles/news-artic...
    ..
    According FDA, sponsors should conduct two randomized placebo-controlled Phase III superiority studies to demonstrate effectiveness if the drug they are testing isn't approved for any other indications, though the agency says that a single Phase III study in combination with other evidence study may be sufficient if the drug has already gone through trials in a closely related indication or if the results of efficacy in a single trial are "highly robust."

    FDA also says the study protocol should specify the type of donors (i.e., donation after brain death, donor after cardiac death or living donor) that will be used, as well as the type of organ recovery, storage, transport conditions and post-transplantation immunosuppressive therapy.

    In addition, FDA says that sponsors should plan on building a preapproval safety database of at least 300 patients, but says that a smaller database may be appropriate "depending on the benefit demonstrated."
    - -
    In the study, Dr. Luis Fernandez of the University of Wisconsin used a non-human primate model to evaluate the outcomes of kidney transplantation from brain dead donors. Kidneys that were treated with rhC1INH prior to transplantation had a significantly lower incidence of delayed graft bfunction (DGF) when transplanted to the recipient animal s. Dr. Fernandez and colleagues were also able to show how rhC1INH inhibited the complement cascade to confer this benefit.

    www.drugs.com/clinical_trials/pharmin...

    [quote]

    Op 1 juni zal veel nieuws komen......
  4. forum rang 7 lucas D 18 mei 2018 12:21
    quote:

    Cor S schreef op 18 mei 2018 12:12:

    [...]

    Lucas, dit is toch niet meer te volgen.... - wat een koers verloop...

    Ja, Cor sta ook met mijn oren te klapperen, maar dat deed ik gisteren ook, ik had nooit verwacht dat op de 1e kwartaal cijfers zo raar gereageerd zou worden, wel dus. Zie dit als een herstel van het verkeerde inzicht van veel aandeelhouders.
    Dit heeft een paar jongens en meisjes een aardige duit gekost.
9.480 Posts
Pagina: «« 1 ... 292 293 294 295 296 ... 474 »» | Laatste |Omhoog ↑

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