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Insmed Incorporated Message Board

blasedp31 29 posts  |  Last Activity: Jun 23, 2015 3:29 PM Member since: Jan 16, 2013
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  • blasedp31 blasedp31 Jun 23, 2015 3:29 PM Flag

    Check tonight or tomorrow morning.

  • blasedp31 blasedp31 Jun 20, 2015 11:51 AM Flag

    Policy
    Aetna considers mecasermin (Increlex) and mecasermin rinfabate (Iplex)* medically necessary for the treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency (IGFD) who meet all of the following selection criteria.

    Basal insulin-like growth factor-1 (IGF-1) standard deviation score less than or equal to -3.0 for age and sex (see Appendix); and
    Height standard deviation score less than or equal to -3.0 for age and sex (see Appendix); and
    Normal or elevated growth hormone (GH) (defined as stimulated serum GH level (peak level) of greater than 10 nanograms per milliliter (ng/ml) or basal (unstimulated) serum GH level greater than 5 ng/ml).

    * Mecasermin rinfabate (Iplex) is currently not marketed because of a court order related to patent infringement.

    It will be when the patent infringement court order is over.

    Try again, Terry

  • blasedp31 blasedp31 Jun 18, 2015 1:35 PM Flag

    Terry. you loser! I guess imitation is the sincerest form of flattery. Nice clone job!

  • blasedp31 blasedp31 Jun 18, 2015 9:48 AM Flag

    The fabrication is your phony ID Terry! Plus, all the other BS you post!

  • blasedp31 blasedp31 Jun 16, 2015 5:13 PM Flag

    Maybe Insmed could use its new found stock proceeds to buyout the court restrictions on Insmed. to move up the date. Something's better than nothing for Tercica/Genetech's purchaser especially in 2 years

  • Reply to

    Random thoughts and questions about iPlex

    by insmhistorian Jun 16, 2015 1:20 PM
    blasedp31 blasedp31 Jun 16, 2015 1:51 PM Flag

    Ok Terry. Since you feel there is no need to discuss further the Iplex equation, why don't you just butt out when someone else wants to discuss it. But you are such a FOS Loser, you won't be able to, nor will you ever be able to prove that Iplex has no value. No one here is blinded by "wanting to believe" on Iplex. They know the scenario, and it's only a possibility. The only one blinded by a "wanting to believe" is you. You are wanting to believe you and your BS ideas can make a difference!!

  • blasedp31 blasedp31 Jun 16, 2015 10:19 AM Flag

    Hey Numbnuts. Can you prove that Iplex is worthless? You wish it was worthless to prove your point. It has a value to some entity in 2017-18. It seems like proper business sense to wait until prior to the court settlement date to begin the process of selling the rights to the patent, partnering with another entity, or moving forward on it your self. I guess we will have to wait till then to see if you are right, or just full of BS as usual. My guess is you can't prove it is worth zero.

  • Reply to

    RMP

    by biowatchdog Jun 11, 2015 12:55 PM
    blasedp31 blasedp31 Jun 15, 2015 6:38 PM Flag

    Jad. Under the Accelerated Procedure, CHMP has to give an opinion at 150 days, or about 2 months earlier.Is there anyway of knowing if Insmed applied for the Accelerated Procedure?

  • Reply to

    Out on a limb AGAIN

    by justarook04 Jun 11, 2015 9:29 AM
    blasedp31 blasedp31 Jun 11, 2015 4:00 PM Flag

    One of the good things about Terry always letting us know that he is UP XXX%, is that he can never prove it. So it's like everything else he says. All BS.

  • It's quite possible we are within 2 weeks of the first 120 days of the Primary Evaluation, where there is a CHMP overview, provisional Recommendation, and a Consolidated list of Questions. The Clock stops then, and will start up after they receive their answers to questions. At Day 170, CHMP will have comments. Don't know if those are public comments. Maybe by end of August or beginning of September there might be some public information, but I don't know for sure.

  • Reply to

    WOW Amazing

    by surestockholmes Jun 2, 2015 11:45 AM
    blasedp31 blasedp31 Jun 3, 2015 9:55 AM Flag

    Teetertotterterry44. I bet you can't give us a financial analysis breakdown as to how you determined your Buyout price.

  • Reply to

    SI Requested

    by biowatchdog May 27, 2015 11:34 AM
    blasedp31 blasedp31 May 27, 2015 4:00 PM Flag

    Do you think there's any chance that when Terry refers to "Surfs Up" he's actually referring to his toilet overflowing in the basement because of too much BS from him?

  • blasedp31 blasedp31 May 21, 2015 11:03 AM Flag

    That's true. The Shelby is much more of a classic than the "Pony"!!

  • blasedp31 blasedp31 May 21, 2015 10:14 AM Flag

    Some people forget that the patent is an asset, and that patent has value to some bio entity. I could own a '67 ford mustang, or a '70 corvette. To some its just a car, but to others it has value as a classic. Iplex is an asset whose value should become larger as we approach 2018. We just can't pin a value on it as easy as we can a car.

  • Reply to

    Dark Tetrad: Machiavellianism

    by johnmatson61 May 11, 2015 2:24 AM
    blasedp31 blasedp31 May 13, 2015 1:44 PM Flag

    Omigosh, those poor sharks!!

  • Reply to

    Oh,,I didn't think about that!!

    by zake1 May 12, 2015 3:36 PM
    blasedp31 blasedp31 May 13, 2015 12:06 PM Flag

    Historian. I'm not sure all money managers & hedge funds pick a price target of 10%, 50% or 100% to get out. If in fact they have invested millions, have preformed extensive due diligence, and actually believe the company has some long term potential with large business backlogs, or long term patent protection on certain products, they might sell off some of their shares and hold the rest. Some will even buy more if they have a longer term strategy based on their due diligence and company results. Some will sell all for the short term gain. I don't think there is one strategy that fits all.

  • Reply to

    August

    by biowatchdog May 9, 2015 10:30 AM
    blasedp31 blasedp31 May 9, 2015 6:07 PM Flag

    Is there any way of knowing if Insmed applied for Fast Track Review or Approval under Exceptional Circumstances?

  • 09/01/2015
    Record number of medicines for rare diseases recommended for approval in 2014
    Number of medicines with new active substances continues to increase
    In 2014, the European Medicines Agency (EMA) recommended the highest number of orphan designated medicines for marketing authorisation in a year. Out of the 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, providing therapies for patients who often have only few or no treatment options.
    Among them is the first medicine for the treatment of Duchenne muscular dystrophy (Translarna) as well as the first treatment for erythropoietic protoporphyria, a rare genetic disease which causes intolerance to light (Scenesse).
    The past year also saw the first recommendation worldwide of a therapy based on stem cells. The orphan medicine (Holoclar) is a treatment for limbal stem cell deficiency (LSCD), a rare eye condition that can result in blindness.
    Special regulatory pathways were used for these three medicines (conditionalmarketing authorisation for Translarna and Holoclar, and approval under exceptional circumstances for Scenesse). These mechanisms are in place to potentially speed up market access for medicines that fulfill unmet medical needs but for which comprehensive data cannot be provided at the time of application for a marketing authorisation.
    Overall, the number of medicines containing new active substances continues to increase. One in two medicines, either orphan or non-orphan, recommended for approval in 2014, contains a substance that has never been used in medicines before.

  • Reply to

    Primary Evaluation Phase of EMA - Day 80

    by blasedp31 Apr 23, 2015 10:54 AM
    blasedp31 blasedp31 Apr 26, 2015 11:52 AM Flag

    This part of the Evaluation system:

    • The applicant has to submit a ‘dossier’ of scientific information on
    quality, efficacy and safety to support the application
    • The CHMP appoints two of its members to act as “Rapporteurs” who will
    do the evaluation on behalf of the Community.
    • Each Rapporteur has a team of experts in the field of Quality, Safety,
    Efficacy, so two teams will evaluate the dossier
    • The Rapporteurs’ assessment is a recommendation to CHMP and forms
    the basis of the discussion
    • Transparent procedure, the Rapporteurs’ assessment is sent to the
    applicant

    Poland and the UK were the co-rapporteurs per Will Lewis, who encouraged Insmed to apply for both NTM and CF in their application. On Day 80 of the Evaluation, the co-rapporteurs send an initial Assessment Report to the CHMP and to Insmed, and by Day 100, the CHMP (Committee on Human Medicinal Products) makes comments.

    So it appears the co-rapporteurs might have a positive assessment to recommend to the CHMP to begin the discussion since they encouraged Insmed to apply for CF and NTM. Maybe by late April or early May, Insmed might have some feedback on their application

  • Reply to

    Primary Evaluation Phase of EMA - Day 80

    by blasedp31 Apr 23, 2015 10:54 AM
    blasedp31 blasedp31 Apr 25, 2015 3:18 PM Flag

    This part of the Evaluation system:

    • The applicant has to submit a ‘dossier’ of scientific information on
    quality, efficacy and safety to support the application
    • The CHMP appoints two of its members to act as “Rapporteurs” who will
    do the evaluation on behalf of the Community.
    • Each Rapporteur has a team of experts in the field of Quality, Safety,
    Efficacy, so two teams will evaluate the dossier
    • The Rapporteurs’ assessment is a recommendation to CHMP and forms
    the basis of the discussion
    • Transparent procedure, the Rapporteurs’ assessment is sent to the
    applicant

    Poland and the UK were the co-rapporteurs per Will Lewis, who encouraged Insmed to apply for both NTM and CF in their application. On Day 80 of the Evaluation, the co-rapporteurs send an initial Assessment Report to the CHMP and to Insmed, and by Day 100, the CHMP (Committee on Human Medicinal Products) makes comments.

    So it appears the co-rapporteurs might have a positive assessment to recommend to the CHMP to begin the discussion since they encouraged Insmed to apply for CF and NTM. Maybe by late April or early May, Insmed might have some feedback on their application

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