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Insmed Incorporated Message Board

jad9000 347 posts  |  Last Activity: 14 minutes ago Member since: Nov 3, 2004
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  • Reply to

    New Bill In Congress To Expedite FDA Approval

    by jad9000 Aug 8, 2015 9:35 AM
    jad9000 jad9000 Aug 8, 2015 11:55 AM Flag

    Repost. It is also great that this is a bipartisan bill that will force the FDA to speed it up, especially when the trials are using the same parameters.

    This is from March of this year. This Bill requires the FDA to review and approve within 90 days. If the Bill is voted into law, our timetable may be sped up dramatically. And, as we know, our rules mandate use. So, all of our 55,000 to 70,000 afflicted will get treatment.

    "New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe.

    The bill, the Speeding Access to Already Approved Pharmaceutical Act, is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014.

    The bill targets something known in the pharmaceutical industry as "drug lag"—the difference between when one product is approved and marketed in one country and when it is finally approved and marketed in subsequent countries."

    Sentiment: Strong Buy

  • jad9000 jad9000 Jun 16, 2015 7:53 AM Flag

    It's 4:40 am on the west coast and Terry, the resident liar who claims to be living these, is up posting. Sure.....Doesn't everyone get up at 4:40 in the am and hit the Yahoo message boards? Right. What a freak show this clown is. Surfs down.

    Sentiment: Strong Buy

  • This is from March of this year. This Bill requires the FDA to review and approve within 90 days. If the Bill is voted into law, our timetable may be sped up dramatically. And, as we know, our rules mandate use. So, all of our 55,000 to 70,000 afflicted will get treatment.

    "New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe.

    The bill, the Speeding Access to Already Approved Pharmaceutical Act, is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014.

    The bill targets something known in the pharmaceutical industry as "drug lag"—the difference between when one product is approved and marketed in one country and when it is finally approved and marketed in subsequent countries."

    Sentiment: Strong Buy

  • Reply to

    OT - NOBODY Cares!

    by terry_insmed Jun 25, 2015 9:58 AM
    jad9000 jad9000 Jun 25, 2015 10:15 AM Flag

    Apparently you do. So, here's how I quit calling you out. Quit doing the following: quit posting your always correct claims of trades that Goldman Sachs couldn't pull off; quit calling posters like biowatchdog liars; quit accusing everyone but yourself of using fake ids (very few - besides you and your 34 + fakes); quit calling people Cathy (who the heck is Cathy and why do we care); quit claiming you live at the beach in California while you post at 3:00 am, 4:00 am California time; quit saying surfs up - It makes you look like a moron.; quit reposting the same nonsense over and over while deleting the prior posts; make your points but quit salting them with weird stuff; talk in complete sentences for once; and use proper grammar. Do all of this and we have a nice board with intelligent comments again. These are the terms and conditions of the armistice.

    Sentiment: Strong Buy

  • Reply to

    RMP

    by biowatchdog Jun 11, 2015 12:55 PM
    jad9000 jad9000 Jun 15, 2015 8:45 PM Flag

    They indicated they were going to apply for it in Great Britain so I assume they applied for it across all the markets but I don't remember them specifically stating it. It seems to be moving through quickly though. My question is how quickly? Could they vote to approve on the 22nd or do they have to have a formal meeting to approve? I have a hard time believing everything grinds to a halt because they all go on holiday in August but it is Europe. I guess we'll find out soon enough.

    Sentiment: Strong Buy

  • Reply to

    Another large block of shares traded this morning

    by justarook04 Jun 15, 2015 11:07 AM
    jad9000 jad9000 Jun 15, 2015 6:46 PM Flag

    At least it seems as though the big block trades are over. I'm guessing, as are you, that the index funds rebalancing had something to do with the action this past week.

    Sentiment: Strong Buy

  • jad9000 jad9000 Jul 13, 2015 7:17 PM Flag

    If everyone just reports abuse on every post Terry and his clown squad make Yahoo will eventually cut hime off. He,she,it is incredibly weird and clearly homophobic. I will guarantee you that if the message board police see him ,her, it as a homophobe they will shut him, her, it down.

    Sentiment: Strong Buy

  • Reply to

    Let's Review Terry

    by jad9000 Aug 7, 2015 10:12 AM
    jad9000 jad9000 Aug 8, 2015 10:17 AM Flag

    Along this same line institutional investors added around 350 thousand shares last quarter and are now close to 88% of total ownership. Add to this the 6% of shares in the option pool and the 2% owned by insiders and strategics and close 96% of shares are locked up. Quite a vote of confidence.

    Sentiment: Strong Buy

  • Reply to

    Let's Review Terry

    by jad9000 Aug 7, 2015 10:12 AM
    jad9000 jad9000 Aug 8, 2015 9:23 AM Flag

    I'm hoping that the 30,000 in the EU plus annual 12% increases (to about 42,000) are mostly in the program and the 55,000 to 70,000 in the US (plus our own 12% annual increases) will also also have a good chunk of people being treated. At a minimum, I expect about $2 billion in 2018 revenues. At $2 billion the company would have a valuation of around $21 billion, or $300 per share. That would put the NPV by year end at close to $150 per share. At the $1.2 billion level, the year end NPV would still be around $90 per share. Either way we will be doing well. Cross your fingers.

    Sentiment: Strong Buy

  • Reply to

    Let's Review Terry

    by jad9000 Aug 7, 2015 10:12 AM
    jad9000 jad9000 Aug 8, 2015 11:50 AM Flag

    Just as we know Terry has deleted all his morning posts and reposted them after getting lots of thumbs down. He is nothing if not predictably idiotic. Bash, insult, praise himself, delete posts, repost, bash, insult, praise himself,, delete posts, repost, bash, insult, praise himself, delete posts, repost, bash, insult, praise himself, delete posts, repost, bash, insult, praise himself, delete posts, repost, bash, insult , praise himself - and on, and on, and on.......... What a complete freak this clown is.

    Sentiment: Strong Buy

  • jad9000 jad9000 Aug 9, 2015 10:18 AM Flag

    They have developed an awful lot of capacity very early. Why? What's the point? Clearly they believe they will need it sooner than later. We may all be off on how soon and how much revenue they might be looking at. As an example if the get Q1 MA approval and we know, per their deck, there will be 10,000 patients waiting for Arikace by the end of 2016 in Germany and France, how quickly will they capture this group for sales?

    Sentiment: Strong Buy

  • Reply to

    False Hope and the spam- Iplex reality

    by terry_insm Jun 21, 2015 5:14 PM
    jad9000 jad9000 Jun 21, 2015 7:50 PM Flag

    Don't try to confuse the idiot with facts. He's just a liar plain and simple. Don't ever expect rationality or truth from him or his 34 fake ids.

    Sentiment: Strong Buy

  • jad9000 jad9000 Jul 21, 2015 3:01 PM Flag

    Insmed will also own the MAC market and the CF market for patients who also have MAC and/or NTM.

    Sentiment: Strong Buy

  • Reply to

    Note revised one year estimate.....$33.

    by theiceman666911 Aug 7, 2015 3:21 PM
    jad9000 jad9000 Aug 8, 2015 8:59 AM Flag

    I actually didn't understand the Convert label used for the study. Is this an indication of hospitals that will begin treating patients on a case-by-case paid basis like the French hospital - before official marketing authorization is issued? So, are they setting up sales and distribution initially through these facilities before they go mass market? If, and I do mean if, this is the case even a few patients per facility equates to $65,000 x 300, or $20 million in revenues. Any insights into this?

    Sentiment: Strong Buy

  • jad9000 jad9000 Aug 9, 2015 1:50 PM Flag

    And now, per Biowatchdog's comments, they anticipate front loading a substantial number of patients into the projected populations by a more sophisticated identification process. This would mean the 85,000 to 100,000 identified patients in the EU and US would increase pretty dramatically by the time we begin marketing. I thought the current number was pretty big but now it is much bigger. At $60,000 to $65,000 per year per patient (depending upon currency translations) it's a whole lot of money. All good.

    Sentiment: Strong Buy

  • Reply to

    NLY going to 8

    by dragon.slipper Jun 3, 2015 11:02 AM
    jad9000 jad9000 Jun 3, 2015 1:32 PM Flag

    Which is you - a sucker or a fool?

    Sentiment: Strong Buy

  • Reply to

    Terry/kvmncdd, the intellectual giant - not

    by jad9000 Jun 6, 2015 9:54 PM
    jad9000 jad9000 Jun 7, 2015 9:21 PM Flag

    Repost - Terry/kvmncdd really is an illiterate moron.

    Sentiment: Strong Buy

  • jad9000 jad9000 Jun 22, 2015 2:52 PM Flag

    Here's the schedule:
    "The RMS prepares a Draft Assessment Report on day 120 and may close the procedure if a consensus has been reached between the CMS(s) and the RMS. Otherwise,the CMS(s) has 90 more days to approve the Draft Assessment Report, and other documents. Competent authorities of the RMS and the CMS(s) adopt a decision within 30 days after acknowledgement of their agreement to the Assessment Report and other documents. At the end of the Decentralized Procedure with a positive agreement, a national marketing
    authorization will be issued in the RMS and each of the CMS(s)."

    So, it appears approval no later than October but can be sooner.

    Sentiment: Strong Buy

  • Reply to

    German Website!!

    by blank2thisone Jun 24, 2015 2:24 PM
    jad9000 jad9000 Jun 24, 2015 2:42 PM Flag

    The minute they get the go ahead from the EMA every doctor with NTM patients will already be aware that Arikace is effective and available - for over 9,000 patients in Germany and France. As the only approved therapy they have a clear path for NTM. The question is how many doctors prescribe Arikace for CF as well. It will be a slower rollout but they should start making inroads soon thereafter.

    Sentiment: Strong Buy

  • jad9000 jad9000 Jul 23, 2015 9:05 AM Flag

    The EMA is pushing Arikace thru as fast as possible. They should. Life saving product, no existing approved products. great trial results, strong need, etc. They need to add MAC to the list of approved indications. Then we have a hat trick - CF, NTM, MAC. Add all of them together and the total unduplicated patient population in the EU is close to 45,000 - at $30,000 to $60,000 annual revenue per patient, depending on the treatment duration. That equates to a potential annual revenue stream of around $1.5 billion in the EU alone by the time they fully roll out. And, the EU is less than 30% of the global market. Add to this over 15 years of remaining patent protection and we should get lift off this year.

    Sentiment: Strong Buy

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