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Insmed Incorporated Message Board

blasedp31 47 posts  |  Last Activity: 1 hour 45 minutes ago Member since: Jan 16, 2013
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  • Reply to

    Primary Evaluation Phase of EMA - Day 80

    by blasedp31 Apr 23, 2015 10:54 AM
    blasedp31 blasedp31 1 hour 45 minutes ago 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 22 hours ago 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 11:55 AM Flag

    Vision. As Will Lewis had stated in a conference call or analyst presentation previously, the EMA recommended that Insmed apply for both NTM and CF indications at the same time:

    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 23, 2015 2:34 PM Flag

    Makes you wonder since the secondary close that there have not been many analysts coverage remarks, if the Institutions are silent for a defensive reason. Do they need enough time to pass before they can reasonably comment on Insmed without looking too exploitive should the news be favorable. Should the news be positive in the very near future, the question will be asked again if it was necessary to offer another secondary offering at a lower share price that could have been higher in the future with less dilution. Retail shareholders just don't have the access to upper management since they are not in the position of putting together partnerships, or offering to sell and buy companies or product lines, and need to do due diligence before negotiations take place. Not exactly fair to retail shareholders, but that's the way Wall Street works!

  • Insmed will receive a copy of the Co-Rappoteurs Initial Assessment Report that is delivered to the CHMP on the 80th day after Validation begins. If validation was Feb 1, the 80th day was April 21, If Feb. 15, the 80th day is May 5, If Feb 28, the 80th day is May 18. On Day 100, the CHMP has Comments, but don't know if that is Public information or not.

    Essentially, Insmed will at least have knowledge of what's in the Initial report somewhere between yesterday and May 18. I don't think they will let retail shareholders know what's in it, but you wonder if the institutional holders will be privy to anything. Does anyone know if any of the information is public? If so, we might know something by late May or late June on the CHMP comments from Day 100.

  • Reply to

    Shareholders Annual Meeting......

    by insmhistorian Apr 15, 2015 7:23 PM
    blasedp31 blasedp31 Apr 15, 2015 9:00 PM Flag

    I wonder what the clarification of 5,000,000 shares for the new 2015 Employee Incentive Plan entails. Are these brand new dilutive shares? Or something that's being amended.

  • Reply to

    Yet Another Revenue Projection...

    by risingedge77 Apr 14, 2015 5:10 PM
    blasedp31 blasedp31 Apr 15, 2015 1:08 PM Flag

    Nice clone job, Terry!! Loser!!

  • Reply to

    April Presentation......

    by insmhistorian Apr 13, 2015 3:55 PM
    blasedp31 blasedp31 Apr 13, 2015 4:54 PM Flag

    I checked on Friday, and it was not on Insmed's website.

  • Reply to

    The latest fake ID list from the schizo

    by jad9000 Apr 7, 2015 12:01 PM
    blasedp31 blasedp31 Apr 11, 2015 1:29 PM Flag

    Nice clone job, Terry!!

  • Reply to

    T. Rowe Price.....

    by insmhistorian Apr 10, 2015 4:16 PM
    blasedp31 blasedp31 Apr 10, 2015 4:33 PM Flag

    There was a post earlier. Their Health Science Fund purchased the stock. They owned about 377,000 shares at end of last year. I think they own about 13% of the stock now. They must like something about Insmed!!

  • Reply to

    You are not going to like this

    by yogiberraofbadnews Apr 7, 2015 11:28 AM
    blasedp31 blasedp31 Apr 8, 2015 3:57 PM Flag

    And what type of drug is it?

  • Reply to

    Unreal-----Thanks a bunch Lewis----------

    by blueyedcatch Mar 30, 2015 4:29 PM
    blasedp31 blasedp31 Mar 30, 2015 8:52 PM Flag

    Zake. Good points. The following was in market watch today:

    If Monday’s deal-making in the pharmaceutical world is any indication, there will be no slowing of merger activity from last year’s $212 billion record for the sector.

    The world’s drug makers continue to fret over the so-called patent cliff that many companies are sliding over, and many are struggling to find new blockbuster products.

    The patent cliff, in which the exclusive rights to top-selling drugs expires, has been a theme bedeviling the industry for several years. While a handful of drug makers are inventing new products that will sustain them, others are buying their way to a more stable future.

    “Big Pharma is running low on innovation,” said Heather Behanna, analyst for Wedbush Securities.

    But there is a silver lining in that, she said.

    “Interest rates being so low makes it easy for larger companies to get money for acquisitions,” she said. “And some innovative small companies out there are about to embark on a transition to commercialization. Therefore, an acquirer can leverage its own infrastructure and basically reap the rewards of the novel products coming from the smaller companies.”

    I think Lewis is working on several options. You have to spend money to make money. The more options he has for Insmed's benefit will be worth something. If you can get 10, 12, 15 or 20x future earnings in today's market, why wouldn't you?

  • Reply to

    Unreal-----Thanks a bunch Lewis----------

    by blueyedcatch Mar 30, 2015 4:29 PM
    blasedp31 blasedp31 Mar 30, 2015 4:52 PM Flag

    It was a guess on my part based upon the day's close. I could be off.

  • Reply to

    Unreal-----Thanks a bunch Lewis----------

    by blueyedcatch Mar 30, 2015 4:29 PM
    blasedp31 blasedp31 Mar 30, 2015 4:34 PM Flag

    With $200 million you could certainly buy another company, restart production of Iplex, or partner with a number of firms for new or existing therapies. I wonder when they will announce one or all of them.

  • BRIDGEWATER, N.J. --(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq:INSM) announced today that it has commenced an underwritten public offering of 10.0 million shares of its common stock. All of the shares of common stock in the offering are to be sold by Insmed

  • blasedp31 blasedp31 Mar 25, 2015 12:03 PM Flag

    No problem. Terry is entitled to his opinion, but to me Iplex is still an unknown valued asset. He may be correct that Insmed thinks its dead or won't resurrect it due to cost, but to me it's like a good professional ball player coming off the Disabled List. He hasn't been productive, but when his time is ready, he'll be worth his salary. It's just a waiting game. Some entity will want the rights to Iplex when it comes off the October 2017 timeline.

  • blasedp31 blasedp31 Mar 25, 2015 11:41 AM Flag

    My best guess would be for Iplex since they have already utilized the drug in research and application for the drug as a therapy. It might be on the shelf for now, but it doesn't mean it's dead. It is still an asset of unknown value. With October 2017 about 30 months away, another entity or Insmed would probably want a 12 - 15 month running start to get the drug up and available for use by late 2017 or 2018, which is only good business sense.

  • Reply to

    Is Yahoo having problems this Am?

    by blueyedcatch Mar 23, 2015 10:07 AM
    blasedp31 blasedp31 Mar 23, 2015 4:33 PM Flag

    From past experience, that is good sound advice. Just because he has a TV show, and a charitable trust, doesn't make him an honorable advisor. Read Aaron Task interview with Jim when they discuss market manipulation.

  • Reply to

    timeline: this week

    by brogers_1 Mar 21, 2015 4:06 PM
    blasedp31 blasedp31 Mar 21, 2015 5:56 PM Flag

    Brogers. I'm not sure if your dates are correct on the EMA CHMP meeting , but the following timeline came from the EMA, and sort of gives an explanation of the the Evaluation process once the application was validated. I made an assumption on the Validation date, since I'm not sure if an exact date was ever announced.

    Let's assume that Feb 1, 2015 is when Insmed's Application was validated by the EMA, thus starting the clock. 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.

  • What do you suppose is Will Lewis' intention at the Analyst Day? Will they be presenting any clinical updates, or is it a meet and greet with the typical updated information we hear at Investor Conferences?

INSM
23.25-0.21(-0.90%)Apr 24 4:00 PMEDT