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INSM - Insmed - Deel 16

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  5. [verwijderd] 10 maart 2009 16:21

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    quote:

    Rieltijm schreef:

    [quote=Rieltijm]
    He goes weer lekker !

    +5% op .945 (wel weinig volume)

    Riel T
    [/quote]

    .98 en 8,8% plus
    en de 1 dollar (11% plussen)
  6. [verwijderd] 10 maart 2009 16:23

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    quote:

    Rieltijm schreef:

    [quote=Rieltijm]
    [quote=Rieltijm]
    He goes weer lekker !

    +5% op .945 (wel weinig volume)

    Riel T
    [/quote]

    .98 en 8,8% plus
    [/quote]

    en de 1 dollar (11% plussen)
    Nu stop ik ermee hoor... 1.03 en 14,4%

    Ga maar ff achterover leunen en genieten....
  8. [verwijderd] 10 maart 2009 16:23

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    quote:

    crackedtooth schreef:

    paar daagjes er tussenuit
    dus alleen traag gsm internet
    maar blijf heel erg bullish mbt insmed

    Pats boem, die gaat goed. 1$ gepasseerd!
    Crack weg, de koers omhoog, even doorzetten, mooie verrassing bij Cracks terugkomst!
  10. [verwijderd] 10 maart 2009 16:32

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    Mensen

    Dit aandeel gaat vele malen hoger de komende jaren .
    4 - 6 $ makkelijk mogelijk

    Momenteel wordt alleen nog maar de cash per aandeel gewaardeerd .

    Ken je nagaan als de positieve resultaten van de produktenportifolio ook gaan binnen rollen .

    Dit jaar ook sterk winstgevend . Voor de 1 ste keer in het bestaan en in de moeilijkste periode van de wereld economie .

    gefeliciteerd voor de volhouders

  14. [verwijderd] 10 maart 2009 16:40

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    Ik heb een vooruitziende blik geloof ik

    BIG NEWS:

    FDA Position on Allowing Patients with ALS Access to Iplex under an IND

    www.fda.gov/cder/drug/infopage/mecase...

    Mensen

    Dit aandeel gaat vele malen hoger de komende jaren .
    4 - 6 $ makkelijk mogelijk

    Momenteel wordt alleen nog maar de cash per aandeel gewaardeerd .

    Ken je nagaan als de positieve resultaten van de produktenportifolio ook gaan binnen rollen .

    Dit jaar ook sterk winstgevend . Voor de 1 ste keer in het bestaan en in de moeilijkste periode van de wereld economie .

    gefeliciteerd voor de volhouders
  15. [verwijderd] 10 maart 2009 16:42

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    FDA Position on Allowing Patients with ALS Access to Iplex under an IND



    Today, the Food and Drug Administration is sharing with the public its decision to allow patients with Amyotrophic Lateral Sclerosis, a fatal neurodegenerative disease also known as Lou Gehrig’s Disease, or ALS, to have access to a drug called Iplex under an Investigational New Drug (IND) application. Iplex (mecasermin rinfabate [rDNA origin] injection), is a combination of two substances: human insulin-like growth factor 1 (IGF-1) and human insulin-like growth factor-binding protein-3 (rhIGFBP-3). Iplex is approved by the FDA only for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. The drug is currently not marketed because of a court order related to patent infringement. Iplex is made by Insmed, a biologics company headquartered in Richmond, Virginia.

    FDA’s Decision

    The FDA and Insmed have agreed that access to Iplex for investigational use in patients with ALS will occur in two ways under Investigational New Drug applications (INDs):

    Single-patient INDs requesting “compassionate use” of Iplex for treatment of named patients with ALS, received and date-stamped by FDA’s document room by close of business on March 6,
    2009, will be allowed to proceed, and Insmed has agreed to supply Iplex to those patients; and

    The remaining supply of Iplex, which is very limited, will be used by Insmed to conduct a clinical trial under an IND in which other patients with ALS who are interested in receiving Iplex treatment will be randomly assigned to receive drug through a lottery system.
    All patients who receive Iplex under either a single-patient IND or in the Insmed clinical trial must be adequately informed by their treating physician of the possible benefits and risks of the treatment. To facilitate the informed consent process, FDA is making available other documents, as described below, to ensure that healthcare providers and patients have access to more complete information related to the potential risks and benefits of Iplex treatment.

    FDA has agreed to allow Insmed to submit a request for cost recovery under existing IND regulations to offset the costs associated with conducting the planned clinical trial. The physicians who submitted the single-patient INDs for “compassionate use” of Iplex will be asked to participate in the data collection for the Insmed clinical trial in order to maximize the collection of data from the very limited supply of drug.

    For further details regarding the Insmed clinical trial, including the process for enrollment into the lottery, contact Insmed at (804) 565-3083 or iplex_als@insmed.com.

    Rationale for FDA’s Decision

    The FDA’s decision comes after serious consideration of the needs of patients with ALS and the practical limitations posed by the extremely limited supply of the drug. The agency has carefully reviewed all available studies and data on the potential benefits and risks to patients with ALS, as well as the need to have as fair a plan as possible for allocating the limited supply of the drug among the patients who want to receive it.

    FDA has received a number of single-patient IND requests from physicians to allow “compassionate use” of Iplex for named patients with ALS. In reaching its decision on permitting investigational use of Iplex in patients with ALS, FDA recognized that solely granting access to the drug under single-patient INDs would rapidly deplete the limited supply of Iplex and make it virtually impossible to conduct a controlled clinical trial. This is critical, because without adequate controlled clinical trials, it is not be possible to determine whether Iplex is effective, or harmful, in patients with ALS.

    The FDA believes its decision represents the fairest way possible to provide access to Iplex, first, because Insmed does not have enough drug for every patient who may request it and, second, because it is important to maximize what can be learned from the remaining supply of drug in case it does have benefit, and could be further developed for widespread use by patients with ALS.

    FDA has attempted to balance the needs of individual patients who are desperately seeking treatment options for this devastating disease with the need to learn if the drug is in fact beneficial, or harmful, in treating patients with ALS. These considerations were weighed over the last few weeks by FDA scientists and physicians, who held a series of meetings with Insmed and internal meetings to discuss the best path forward.

    Chronology

    With the intent of being transparent regarding our decision, today we are making public the available information and study findings on the use of Iplex in patients with ALS that served as the basis for our decision.

    Approximately 10 weeks ago, the FDA first received requests from physicians requesting access to Iplex for “compassionate use” treatment of named patients with ALS under single-patient INDs. After careful review and consideration, FDA initially denied those requests because the agency was not aware of any data that suggested that Iplex was beneficial in the treatment of ALS. In addition, FDA was aware of data from controlled trials for a very similar drug (IGF-1 or Myotrophin) that failed to demonstrate benefit, and in some trials suggested a worse outcome in patients treated with IGF-1 compared to patients treated with placebo (no treatment). The data for IGF-1 came from four randomized, double-blind, placebo-controlled trials as well as randomized access to IGF-1 through a Treatment IND. Reports of three of the controlled trials of IGF-1 have been published in the medical literature1; the fourth trial and the Treatment IND experience (both of which suggested harm of IGF-1) have not been published but were reported to FDA by the sponsor of the IGF-1 development program. As part of today’s web posting, FDA is making available a summary of the controlled data for the use of IGF-1 in the treatment of ALS.

    In addition, although it was not a basis for the denial of the single-patient IND requests, FDA also noted in those denials that the only way to determine if Iplex was beneficial or harmful in the treatment of ALS was to conduct a controlled clinical trial similar to those conducted for IGF-1. Given the variable natural history of ALS, it is not possible to interpret anecdotal experience that may arise from uncontrolled treatment use of the drug, such as was requested under the single-patient INDs. FDA’s regulations on access to investigational drugs for treatment use acknowledge this limitation and, in general, there is an expectation that a drug will be under development and adequate data will be available to evaluate the drug’s safety and effectiveness before single-patient access under an IND is granted. Finally, FDA was concerned that due to the devastating nature of the disease and lack of existing treatments, demand for access to Iplex under single-patient INDs might become widespread, and that such access to the drug would impair the ability to conduct a proper clinical trial to determine if the drug was beneficial or harmful in the treatment of ALS. This concern was cited in our communications to the physicians who submitted the single-patient INDs. We also made clear
  16. [verwijderd] 10 maart 2009 16:45

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    quote:

    Rieltijm schreef:

    [quote=gismo74]
    BIG NEWS:

    FDA Position on Allowing Patients with ALS Access to Iplex under an IND

    www.fda.gov/cder/drug/infopage/mecase...

    [/quote]
    Verklaart de stijging..? Raar dat er geen PR van Insmed komt...
    Waarschijnlijk vanavond met een uitbereiding in de EU!!! De komende weken richting de 3 dollar!

  17. [verwijderd] 10 maart 2009 16:52

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    FDA: Iplex Not Currently Marketed Because Of Patent Dispute

    Last update: 3/10/2009 11:46:54 AM(MORE TO FOLLOW)

    Dow Jones Newswires (201-938-5400)March 10, 2009 11:46 ET (15:46 GMT
  18. [verwijderd] 10 maart 2009 17:15

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    quote:

    Dirk R. Wijnen schreef:

    FDA: Iplex Not Currently Marketed Because Of Patent Dispute

    Last update: 3/10/2009 11:46:54 AM(MORE TO FOLLOW)

    Dow Jones Newswires (201-938-5400)March 10, 2009 11:46 ET (15:46 GMT
    Dat klopt.
    Vandaar dat Insmed het wel mag leveren (zie accoord van een paar maanden geleden met DNA en IPSEN/Tercica) maar er geen PR over uit mag sturen.

    P.
  19. [verwijderd] 10 maart 2009 17:28

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    vandaar in het bericht van de FDA de regel

    For further details regarding the Insmed clinical trial, including the process for enrollment into the lottery, contact Insmed at (804) 565-3083 or iplex_als@insmed.com.

    www.fda.gov/cder/drug/infopage/mecase...

    !!!!!!!!!! Dit is dus steengoed nieuws !!!!!!!!

    We missen nu Crack voor een verdere toelichting
  20. ludwig mack 10 maart 2009 18:33

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    wat wil je van hem dan ?
    het produkt zelf mag niet gemarketeerd worden voor groeiverstoringen, maar voor wel voor indicatie als, zij het op speciaal voorschrift (dus nog geen echte marketing) maar alleen dan voor als en niet voor iets anders, en dan alleen voor de periode dat het produkt voor als nog geen fda goedkeuring heeft ........., dus nog in testfase.
    dat staat er.
    gr
  21. ludwig mack 10 maart 2009 18:36

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    quote:

    bioscience schreef:

    vandaar in het bericht van de FDA de regel

    For further details regarding the Insmed clinical trial, including the process for enrollment into the lottery, contact Insmed at (804) 565-3083 or iplex_als@insmed.com.

    www.fda.gov/cder/drug/infopage/mecase...

    !!!!!!!!!! Dit is dus steengoed nieuws !!!!!!!!

    We missen nu Crack voor een verdere toelichting
    je doet je naam geen eer aan bio?
    ;-0
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