Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

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Japo schreef op 28 november 2017 11:02:

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nu is de bied 3 x hoger en de koers zakt, snap het gewoon niet

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KarenT schreef op 28 november 2017 11:07:

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Bekijk de eerste 4 regeltjes van bied, en de eerste 4 van de laat. Dan zit je een stuk dichter bij.

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KarenT schreef op 28 november 2017 11:07:

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Bekijk de eerste 4 regeltjes van bied, en de eerste 4 van de laat. Dan zit je een stuk dichter bij.

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Maxima22 schreef op 28 november 2017 11:06:

www.fda.gov/ForPatients/Approvals/Fas...
Als de nood hoog is kan de fda binnen 2 maanden een besluit nemen over toestaan van medicatie voor een bepaald doel.
Als ik de info juist interpreteer dan zal dat dus ook gebeuren binnen 60 dagen.

De nood is hoog, de druk vanuit patiënten, artsen en verzekeraars op de fda is groot.
Bovendien heeft dit medicijn al eerder de fast track status gekregen:
www.pharming.com/pharming-and-santaru...

Hier de tekst van de site van de fda:
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy

Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

Ability to address emerging or anticipated public health need

A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

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Maxima22 schreef op 28 november 2017 11:06:

www.fda.gov/ForPatients/Approvals/Fas...
Als de nood hoog is kan de fda binnen 2 maanden een besluit nemen over toestaan van medicatie voor een bepaald doel.
Als ik de info juist interpreteer dan zal dat dus ook gebeuren binnen 60 dagen.

De nood is hoog, de druk vanuit patiënten, artsen en verzekeraars op de fda is groot.
Bovendien heeft dit medicijn al eerder de fast track status gekregen:
www.pharming.com/pharming-and-santaru...

Hier de tekst van de site van de fda:
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy

Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

Ability to address emerging or anticipated public health need

A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

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KarenT schreef op 28 november 2017 10:38:

Te weinig volume voor goede daghandel vandaag helaas. Heb ze er maar met wat verlies uit gedaan en nog even elders kijken.
Succes allen!

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Japo schreef op 28 november 2017 11:18:

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Als ik op deze print screen de eerste 4 regels bekijk heb je er toch veel meer in de bied, maar de koers stijgt toch niet

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KarenT schreef op 28 november 2017 11:19:

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Als niemand meer bied dan de eerste verkoper gaat de koers inderdaad niet stijgen nee...

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Boytje-D schreef op 28 november 2017 11:19:

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Theoretisch kan het er dan al eind januari zijn!

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Raarrr! schreef op 28 november 2017 11:19:

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Goedemorgen KarenT,het volume is idd teleurstellend,even als het koersverloop van de afgelopen dagen voor wie later (vanaf 1,28/1,29) is ingestapt (zoals ik). Ook de nieuwsupdate van gisteren had nauwelijks effect.

Was van plan long te gaan, maar ben het helemaal eens met uw visie dat het koersverloop nog wel een tijdje door zal kabbelen bij gebrek aan nieuwe input, vandaar dat ik waarschijnlijk op een andere strategie overschakel, daghandel dus. Mag ik vragen met hoeveel stuks u gemiddeld handelt per dag in Pharming?
Met een vriendelijke groet.

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Raarrr! schreef op 28 november 2017 11:19:

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Goedemorgen KarenT,het volume is idd teleurstellend,even als het koersverloop van de afgelopen dagen voor wie later (vanaf 1,28/1,29) is ingestapt (zoals ik). Ook de nieuwsupdate van gisteren had nauwelijks effect.

Was van plan long te gaan, maar ben het helemaal eens met uw visie dat het koersverloop nog wel een tijdje door zal kabbelen bij gebrek aan nieuwe input, vandaar dat ik waarschijnlijk op een andere strategie overschakel, daghandel dus. Mag ik vragen met hoeveel stuks u gemiddeld handelt per dag in Pharming?
Met een vriendelijke groet.

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CJX schreef op 28 november 2017 11:26:

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Correct, we gaan eerst een daling naar 1,22 ~ 1,23 meemaken. Daarna vol long!

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beeldscherm schreef op 28 november 2017 11:19:

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Max, ik heb dat ook al eens eerder hier aangehaald, en ja ik ga daar ook van uit en zeg nog steeds met Pharming knallend het jaar uit.. want er staat letterlijk "BINNEN" 60dgn...kan 1 week zijn 2 wkn name it. van Ruconest is bij de FDA alles bekend een Stempel erop zetten is infeite alles wat ze moeten doen !!!get it!!

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€ schreef op 28 november 2017 11:06:

Bestens aan/verkopen staan niet in het orderboekje, daardoor een wat vertekend beeld.