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Insmed Incorporated Message Board

checksurshorts 41 posts  |  Last Activity: Aug 19, 2014 10:18 AM Member since: Dec 1, 2006
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  • checksurshorts by checksurshorts May 26, 2014 11:23 AM Flag

    This is from a NTM forum and I believe speaks to the compliance issue:

    "Have pseudomonas and need to inhale tobramycin twice a day It's taking a really long time with the nebulizer I have. Anyone have a fast nebulizer that they recommend? I love, love loved the one I got to use as part of the Arikayce trial, but had to give that one back -- super fast, quiet, battery or plug-in. The nebulizer I'm using is taking 40 minutes twice a day plugged in to the wall...going mad!!! Any recommendations would be great -- both the model and manufacturer and any information about insurance coverage.

    Thanks!"

    Sentiment: Strong Buy

  • checksurshorts checksurshorts Jul 27, 2014 4:17 PM Flag

    Thanks!

    "The Phase II and III clinical trials for aerosolized liposomal amikacin or ciprofloxacin for the treatment of P. aeruginosa lung infections in CF and non-CF bronchiectasis patients are evidence that demonstrate that in the next few years the liposome-based antibiotic-delivery systems will prove to be remarkable treatment alternatives for infectious diseases. For P. aeruginosa lung infections, the inhalational route of administration of liposomal antibiotic formula- tions has the potential to increase patient compliance, reduce the duration of the antibiotic treatment and possibly decrease the likelihood of bacterial resistance. The unique properties of liposomes will provide many opportunities to develop a wide range of liposomes to offer a clinically proven, biocompatible versatile plat- form for the enhancement of pharmacological efficacy of antibiotics. It is anticipated that in the next few years, liposomes may be used to deliver a combination of anti- biotic agents (i.e., aminoglycoside and β-lactam) or an antibacterial agent and an inhibitor of a major resistance mechanism (i.e., β-lactam and β-lactamase inhibitor). Also, liposomes that specifically target bacterial cells may be engineered by attaching amino acid fragments, such as antibodies or proteins or appropriate fragments that target specific sites in bacteria. It is envisioned that the future of liposomal antibiotic development is bright with a number of these lipid-based products proving to be remarkable treatment alternatives in the treatment of P. aeruginosa lung infections. "

    Sentiment: Strong Buy

  • Reply to

    Slowly . . .

    by rehdvm2004 Aug 9, 2014 4:59 PM
    checksurshorts checksurshorts Aug 10, 2014 1:25 PM Flag

    Great, you can disappear for 9.5 years or so.

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Aug 5, 2014 12:04 PM Flag

    Will this be a very, very short trial that ends up being halted due to positive results? Duplicating positive results under a primary endpoint of culture conversion will prevent the FDA from having to set a precedent (Heaven forbid). Maybe that is all they are looking for? The conversion was occurring at a rapid rate. The full NTM population trial would then just run its course for future label expansion. IMHO

    "The Company also plans to initiate a second Phase 3 study which will be designed to confirm, in as short a timeframe as possible, the positive culture conversion results seen in the Phase 2 study. This confirmatory study will primarily investigate ARIKAYCE for use in the treatment refractory population with mycobacterium avium complex (MAC) NTM lung infections. This subgroup of the Phase 2 trial’s patients responded particularly strongly to the treatment."

    Sentiment: Strong Buy

  • And the bashers come alive again.

    Sentiment: Strong Buy

  • Reply to

    From NTM Forum

    by checksurshorts Aug 19, 2014 9:58 AM
    checksurshorts checksurshorts Aug 19, 2014 10:10 AM Flag

    "Arikace was awesome. Have you heard much about it? For the phase 2 trial I was on, I think something like 25% of the (treatment refractory) participants were culture negative at the end of the trial. I think if I could have stayed on it longer, I would have gotten there too. Now all I can do is pray that it gets FDA approval soon! The FDA did designate it as a "breakthrough therapy" after the trial results came out, but I don't really know what that will mean in terms of FDA approval. If they need to go through a phase 3 trial, I think we'll still be at least a few years away from it being readily available."

    "Yeah I heard a bit about it, very promising results! I am off meds & culture negative and hope to stay that way forever, but I've seen so many reports on this forum about people who relapsed that it is a comforting thought that new treatments are being developed. I hope FDA approval comes soon for people like you & others who need it."

    Sentiment: Strong Buy

  • Reply to

    Will New Trial be Halted Early?

    by checksurshorts Aug 5, 2014 12:04 PM
    checksurshorts checksurshorts Aug 5, 2014 12:10 PM Flag

    BTW...isn't there a little girl out there that is still alive and with a new set of lungs only because public outcry forced the FDA to bend a little and set precedent?

    Sentiment: Strong Buy

  • Reply to

    Wow...two posts removed fast

    by checksurshorts Jun 6, 2014 11:51 AM
    checksurshorts checksurshorts Jun 6, 2014 12:09 PM Flag

    I posted at the other board

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Aug 19, 2014 9:58 AM Flag

    "Hi all,

    After a glorious one-year drug holiday, I am about to re-start therapy for M. Abscessus. One of the drugs my docs are going to try this time is Clofazimine. Has anyone on here ever taken it? I know it's a longshot, but I'm hoping someone has, and can perhaps share his/her experience.

    I'm well aware that it causes skin discoloration, and I also know that some people develop gastrointestinal issues. But, I'm trying to understand what this really means for patients who have taken it. I totally trust my doctors, though I know they want me to take it, so I wouldn't be too surprised (and also wouldn't blame them) if they've downplayed the side effects a bit. And of course, if you google it, you can find all sorts of ridiculously terrible results. So, I'm seeking some real-life experience."

    [SNIP]

    "I don't really keep in touch with anyone else who has Abscessus, so I don't know how others are doing. Though I've been on and off drugs since I was diagnosed in 2007, I've done pretty well. I've been smear positive much of the time, but am still pretty healthy and have maintained my lung function. I've taken a mix of IV and oral drugs during that time, though the thing that made the most difference for me was taking part in the Arikace clinical trial. I was actually smear negative (though still culture positive) for about six months after the trial, which was a minor miracle for me."

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jun 6, 2014 11:51 AM Flag

    Less than 10 minutes. NTM info....Insmed is supporting NTM info and ATS meeting

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jul 11, 2014 5:07 PM Flag

    On July 8, 2014, Insmed Incorporated (the “Company”) entered into a Commercialization Agreement (the “Agreement”) with PARI Pharma GmbH (“PARI”) for the manufacture and supply of eFlow nebulizer systems and related accessories (the “Device”) as optimized for use with the Company’s proprietary liposomal amikacin for inhalation. The Agreement has an initial term of fifteen (15) years from the first commercial sale of the Device (the “Initial Term”). The term of the Agreement may be extended by the Company for an additional five (5) years by providing written notice to PARI at the least one (1) year prior to the expiration of the Initial Term. Notwithstanding the foregoing, the parties have certain rights and obligations under the Agreement prior to the commencement of the Initial Term. The Agreement allows for termination by either party upon the occurrence of certain events, including (i) the material breach by the other party of any provision of the Agreement, (ii) the default or bankruptcy of the other party, or (iii) upon termination by the Company of the License Agreement between the parties.

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jul 15, 2014 12:18 AM Flag

    Insmed has been rising, and one investor is squeezing income from the move.

    optionMONSTER's tracking programs detected the sale of 2,000 July 19 puts for $1.07 and the purchase of 2,000 July 16 puts for $0.22. Volume was below open interest at the lower strike, which suggests an existing short position was closed and rolled up.

    Selling puts lets investors earn income in return for insuring other traders against a drop. If the stock remains above the strike price, they'll keep the premium and the contracts they sold short will expire worthless. But they're at risk of potentially big losses if shares decline. (See our Education section)

    INSM is up 0.16 percent to $19.04 in midday trading and has risen 50 percent in the last month. Most of that move came after the Food and Drug Administration designated its Arikayce lung drug a breakthrough therapy, which opens the door to potentially quicker approval.

    Today's option trader apparently sold the July 16 puts when the stock was lower and has now made money on the bet. Rolling up to the 19 let him or her collect an additional $0.85 and raises the level at which they must get long by $3.

    More than 4,800 contracts have traded so far in the session, more than triple INSM's daily average for the last month.

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jul 22, 2014 11:54 PM Flag

    "NTM Info & Research has joined the European Organization for Rare Diseases (EURORDIs) as an associate member organization.

    A non-governmental patient-driven alliance of organizations and individuals active in the field of rare diseases in Europe, EURORDIS supports the creation and development of rare disease national alliances and disease-specific European federations and networks. It represents over 600 rare disease patient organizations in more than 50 countries, covering more than 4000 rare diseases, and is the voice of 30 million people affected by rare diseases throughout Europe.

    EURORDIS actively participates in the development and implementation of policies to bring real solutions to people living with rare diseases in the areas of prevention, diagnostics, care, research, medicines development, social services, information, education, and more. The organization was founded in 1997. "

    Sentiment: Strong Buy

  • Reply to

    NTMir Joins NORD

    by checksurshorts Jul 23, 2014 5:56 PM
    checksurshorts checksurshorts Jul 24, 2014 12:26 AM Flag

    If the NTM trial "failed" why do you think the FDA awarded breakthrough status based upon same trial? TIA

    Sentiment: Strong Buy

  • Reply to

    Pricing for 6 months of NTM treatment

    by risingedge77 Jun 24, 2014 3:27 PM
    checksurshorts checksurshorts Jun 24, 2014 10:53 PM Flag

    I don't expect you to understand that the main reason the primary endpoint was not reached was a participant ended up (and not due to Arikayce) in the same state as your brain -- dead. And please keep your calculator fetish to yourself.

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jul 23, 2014 12:04 AM Flag

    From NTMir. Insmed will be there...Shire will be there.

    "A Rare Patient Advocacy Summit is being held in Huntington Beach, CA on September 11th & 12th. It is recommended for patients, caregivers, family members, patient advocates and rare disease organizations.

    The Summit is organized by The Global Gene Project, one of the leading rare disease patient advocacy organizations in the world with over 500 global organizations. Patients can attend the summit or register for the webcast. "

    Sentiment: Strong Buy

  • Reply to

    From NTM Forum

    by checksurshorts Aug 19, 2014 9:58 AM
    checksurshorts checksurshorts Aug 19, 2014 10:18 AM Flag

    From what I understand, Abscessus is a really tough bug to eradicate.

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jul 31, 2014 4:58 PM Flag

    Steven Cohen billionaire hedge fund guy appears to be in. Haven't fully read yet.

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jun 19, 2014 2:38 PM Flag

    "Thought leaders bullish on Insmed data for Arikayce, says Leerink
    Following a call with two key opinion leaders in the Non-Tuberculous Mycobacteria space, Leerink said both specialists' view Insmed 's Arikayce data as "terrific" and were encouraged by yesterday’s breakthrough designation news, though they were hesitant to predict if the FDA will approve the drug on the available data. Leerink reiterates its Outperform rating and $30 price target on Insmed."

    Sentiment: Strong Buy

  • checksurshorts checksurshorts Jun 19, 2014 1:22 AM Flag

    Sigma -

    This is truly a great post. Thank you

    Sentiment: Strong Buy

INSM
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