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Insmed Incorporated Message Board

insm_truth_teller 45 posts  |  Last Activity: Jul 23, 2014 2:29 PM Member since: Jul 19, 2012
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  • insm_truth_teller insm_truth_teller Jul 23, 2014 2:29 PM Flag

    A Generic thread . . .by rehdvm2004
    Baloney! TOBI is being replaced by TIP anyway. TIP is Novartis. Approved. Decreased sales of TOBI are not necessarily generic. Same old limited understanding of the medicine and what is going on with CF. Baloney on both ends.
    Same for Premiplex/Iplex threads. INSM is out of any type of involvement with Premiplex/Iplex . . . thrice removed via Premacure . . . Shire . . . Abbie(?). But the same old harpies that were blathering in 2009 are still on this MB. They have bought and sold 10,000s of shares because they were the day traders, MMs, wanabees that duped retail investors. NAME RECOGNITION!!! But they were FOS then, and FOS now.

    The seat of medical knowledge with ROP and Premacure was . . . and continue to be Hellstrom and Smith. They are the doctors that formulated the theory and algorithm for treating premies and (through Premacure) approached INSM as the optimum source of the IGF-1/rBP-3 treatment modality. Good for them.
    Facts: INSM is out of the recombinant technology business. They sold all their interests and all the people who knew anything about that business are gonzo. Including the guy they hired from Amagen, Steve Glover. Gonzo.
    So GLTAL and place your chips on the Arikayce square. The NTM market will be the key to the future. Disregard the piano tuner thread because it is Horse Pucky!

  • Reply to

    Premiplex

    by jsblvbjb Jul 18, 2014 2:32 PM
    insm_truth_teller insm_truth_teller Jul 23, 2014 8:49 AM Flag

    thiis thread for idiots. * INSM is out of the recombinant technology business. They sold all their interests and all the people who knew anything about that business are gonzo. Including the guy they hired

  • Reply to

    Interesting tidbit

    by fmjtfb Jul 3, 2014 7:08 PM
    insm_truth_teller insm_truth_teller Jul 23, 2014 8:43 AM Flag

    Reply to NTM revenue = $3.5 billion (110,000 cases * $35,000) by blank2thisone •Jun 29, 2014 4:15 PM
    gertrude_theduck • Jul 16, 2014 10:23 PM Flag
    nonsense.\ I suggest this poster{if real} watch the symposium.\ the 110000 cases you cite are all cases,but only a few thousand will be critical enough and the treatment decision to be considered

  • insm_truth_teller insm_truth_teller Jul 23, 2014 8:41 AM Flag

    Spam but true.

  • Reply to

    Drug efficacy and side effects datas

    by tanweikate Jun 22, 2014 8:21 AM
    insm_truth_teller insm_truth_teller Jul 21, 2014 11:24 AM Flag

    Reply to NTM revenue = $3.5 billion (110,000 cases * $35,000) by blank2thisone •Jun 29, 2014 4:15 PM
    gertrude_theduck • Jul 16, 2014 10:23 PM Flag
    nonsense.\ I suggest this poster{if real} watch the symposium.\ the 110000 cases you cite are all cases,but only a few thousand will be critical enough and the treatment decision to be considered.

  • Reply to

    Premiplex

    by jsblvbjb Jul 18, 2014 2:32 PM
    insm_truth_teller insm_truth_teller Jul 21, 2014 10:33 AM Flag

    I know you have been here for a long time and should know better to post misleading information like this.
    Insmed will receive zero on anything regarding premiplex selling all rights to this last year.all rights.

  • Reply to

    Premiplex

    by jsblvbjb Jul 18, 2014 2:32 PM
    insm_truth_teller insm_truth_teller Jul 21, 2014 10:32 AM Flag

    gertrude_theduck • 22 hours ago Flag
    3users liked this postsusers disliked this posts3Reply
    5 year old product trial
    The iplex production story is a fabrication. No future comments.

  • insm_truth_teller insm_truth_teller Jul 21, 2014 10:24 AM Flag

    ,nonsense.\ I suggest this poster{if real} watch the symposium.\ the 110000 cases you cite are all case

  • insm_truth_teller insm_truth_teller Apr 5, 2014 11:53 AM Flag

    Insmed setback as lead therapy flunks&.Insmed is once again hustling to put the best spin possible on a clinical study of its only therapy. By John Carroll
    Insmed is once again hustling to put the best spin possible on a clinical study of its only therapy.

    The Monmouth Junction, NJ-based biotech ($INSM) acknowledged that its Phase II study of the inhaled antibiotic Arikayce for nontuberculous mycobacterial (NTM) lung infections failed the primary endpoint--a reduction in bacterial density used as a measure of infection.
    Last summer the biotech's share price was hammered after it posted head-to-head Phase III results for Arikayce against Tobi, a twice-daily antibiotic from Novartis ($NVS) used to prevent lung infections in high-risk CF patients. Tobi actually did a little better than Arikayce but the experimental therapy with the easier dosing schedule was statistically noninferior. Investors blew right past the company's optimism and the stock price was battered

  • Insmed setback as lead therapy flunks&.Insmed is once again hustling to put the best spin possible on a clinical study of its only therapy. By John Carroll
    Insmed is once again hustling to put the best spin possible on a clinical study of its only therapy.

    The Monmouth Junction, NJ-based biotech ($INSM) acknowledged that its Phase II study of the inhaled antibiotic Arikayce for nontuberculous mycobacterial (NTM) lung infections failed the primary endpoint--a reduction in bacterial density used as a measure of infection.
    Last summer the biotech's share price was hammered after it posted head-to-head Phase III results for Arikayce against Tobi, a twice-daily antibiotic from Novartis ($NVS) used to prevent lung infections in high-risk CF patients. Tobi actually did a little better than Arikayce but the experimental therapy with the easier dosing schedule was statistically noninferior. Investors blew right past the company's optimism and the stock price was battered

  • insm_truth_teller insm_truth_teller Apr 5, 2014 10:41 AM Flag

    michael_coen let me help you:

    • in the Arikace arm 11 of 44 subjects culture converted by day84, many of them by day28 (% by day28 -don't know yet).

    • in the "empty liposome" arm 3 of 45 culture converted.

    What we don't know is why were the culture conversions EXCLUDED from the 7-point scale.
    ClincalTrials dot gov says: "Change in semi-quantitative mycobacterial culture results from baseline to end of treatment"
    How much more quantitative do you want than culture conversion?!
    We also don't know what was agreed with the FDA in the first place (tricky when trying to figure out who messed up) but handy (once again) that Insmed's new execs can get options at $20 rather than $40.

    also (from the ATS poster abstract):

    data each 28 days:

    • sputum for semi-quant mycobaterial culture (l o outcome)
    • smear status
    • signs and symptoms assessment
    • pulmonary exacerbation occurence
    • antimycobacterial drug rescue
    • 6-min walk distance
    • computed tomography of teh chest
    • respiratory questionnaire
    • QOL-B-NTM (non CF subjects) quality of life
    • CFRSD
    • CFQ-R (CF)
    • global rating of health
    • spirometry
    • clinical and laboratory safety

    each 28 days up to D168 +28 days off drug

    the study is on-going with 72 patients (82%) completed the double-blind phase and 41 (57.7%) completed the open-label phase (so far)

    90 started 1 died
    89 completed
    72 continued into open label
    41 of which have already finished

    72 OF 89 CONTINUED INTO OPEN LABEL..

  • insm_truth_teller insm_truth_teller Apr 5, 2014 5:36 AM Flag

    michael_coen
    Drayton Wise is the most significant hire: his 15 years at Norvatis is all pulmonary. His connections (with Novartis) won't sever either, so this hire allows a nice "back-channel" to Insmed should Norvatis be interested in retaining (and expanding) it's pulmonary product line (if you know what I mean); Wise will have truck-load of $20 options soon (handy for when price is $120). It is VERY good hire for all shareholders, assuming no more unlawful and/or immoral dilutions

  • insm_truth_teller insm_truth_teller Apr 5, 2014 5:29 AM Flag

    by rehdvm2004
    But the Control article in the NTM clinical trial was the liposome without amikacin. That is still a pharmaceutically active moiety because it cuts the thickness of mucous . . . which allows NTM patients to clear their lungs better. There are always scientific reasons for a clinical condition. In CF patients, they do not secrete enough mucous. In infectious patients, the bacteria hide in the mucous and secrete (bacterial) excretory products that thicken the mucous. So a comparison of Arikace with non-antibiotic liposome is a comparison of amakacin-liposome with liposome. I have been saying since the merger that the liposome that envelops the amakacin has a multitude of other clinical applications for inhalational therapy. I asked WL once in a CC about that and he acknowledged same, but said (sic) we have to dance with the date that brung us! I think that is why Dr. Gupta is now leaving. She slipped up over the cancer in rats which was a no-brainer response, but LaBella and the Transave CEO fell on their swords on that one. This one belongs to Dr. G. GLTAL but the regulatory explanations are going to be challenging. They really needed to have a pathologist person closely associated with their regulatory leadership. The definition of a pathologist is a medical person who can diagnose any disease accurately and prescribe the proper treatment , , , only one day too late.
    EOS.
    Forget about TB. That mycobacterium has a totally different cell wall than NTM.

  • insm_truth_teller insm_truth_teller Apr 5, 2014 5:19 AM Flag

    ya mean there is a reason she is leaving? ....

    by terry_insm
    "As part of the organizational changes, Dr. Renu Gupta, Executive Vice President, Development and Chief Medical Officer (CMO), will move to a new role as Special Adviser to the CEO, which "will allow Dr. Gupta to smoothly and effectively transition her current responsibilities prior to departing the Co. in the Fall" to pursue other interests.
    "-------.....................Will! you get one atta boy for blcht

  • insm_truth_teller insm_truth_teller Apr 5, 2014 4:52 AM Flag

    Answer to fudfighter 2
    thisidistakenalready
    Red is by far the most substantively forthright, clinically knowledgeable, and informative poster that i can recall to have to frequented this clown board.
    You, d'oh, don't even look a gift horse in the mouth; you're too busy looking up the wrong end.

  • insm_truth_teller insm_truth_teller Apr 5, 2014 4:43 AM Flag

    ichael_coen • 20 hours ago Flag
    4users liked this postsusers disliked this posts0Reply
    let me help you:

    • in the Arikace arm 11 of 44 subjects culture converted by day84, many of them by day28 (% by day28 -don't know yet).

    • in the "empty liposome" arm 3 of 45 culture converted.

    What we don't know is why were the culture conversions EXCLUDED from the 7-point scale.
    ClincalTrials dot gov says: "Change in semi-quantitative mycobacterial culture results from baseline to end of treatment"
    How much more quantitative do you want than culture conversion?!
    We also don't know what was agreed with the FDA in the first place (tricky when trying to figure out who messed up) but handy (once again) that Insmed's new execs can get options at $20 rather than $40.

    also (from the ATS poster abstract):

    data each 28 days:

    • sputum for semi-quant mycobaterial culture (l o outcome)
    • smear status
    • signs and symptoms assessment
    • pulmonary exacerbation occurence
    • antimycobacterial drug rescue
    • 6-min walk distance
    • computed tomography of teh chest
    • respiratory questionnaire
    • QOL-B-NTM (non CF subjects) quality of life
    • CFRSD
    • CFQ-R (CF)
    • global rating of health
    • spirometry
    • clinical and laboratory safety

    each 28 days up to D168 +28 days off drug

    the study is on-going with 72 patients (82%) completed the double-blind phase and 41 (57.7%) completed the open-label phase (so far)

    90 started 1 died
    89 completed
    72 continued into open label
    41 of which have already finished

    72 OF 89 CONTINUED INTO OPEN LABEL...

  • insm_truth_teller insm_truth_teller Apr 5, 2014 4:30 AM Flag

    rehdvm2004 • 20 hours ago Flag
    1users liked this postsusers disliked this posts2Reply
    The regulatory challenge is to clarify why the placebo had such a beneficial effect in comparison with Arikace. Does that not strike you as unusual in a drug trial that is not with an existing therapy (like Arikace v. TOBI) or a comparative study between two "active agents?" It is presumptively robotic in this business to not look "outside" the basis of your own theories. It is very narrow minded and potentially catastrophic. 70% of new biopharmas fail. Why do you think that is? Too focused on MMD instead of Duchennes? God gave people brains that allow abstract thinking. Laziness only makes for ignorance and failure. But the answer is there. Staring at everyone who chooses to think.

  • insm_truth_teller insm_truth_teller Apr 5, 2014 3:00 AM Flag

    Further . . . Mycobacterium tuberculosis has a totally different acid fast cell wall. The "waxy" substances in the cell wall are different from the many strains of NTM. The difference makes them more resistant to antibiotics. The posters on this MB fail almost every time to look at the facts. The reason that NTM and TB are so difficult to kill (have a bactericidal effect upon) is that they are so slow in growing. It takes weeks for enough TB to grow in culture that any confirmatory diagnosis of the strain of TB can be completed. Same for NTM. Weeks of growth. That is why INSM chose to use a novel sputum colony count method rather than quantifying growth on a culture plate. But more importantly, look at the reason why antibiotics are efficacious. They slow reproduction of a rapidly growing bacteria to the point that the bodies immune system can catch up and overcome an infection. Same with chemo and cancer. The cancer cells are selectively more susceptible to chemo because they are replicating faster than normal cells. So how do you kill a slow growing bacteria - find the molecular kink in its armor. In this case, attack the cell wall. Amikacin does not do that. If you do the search at Clinical Trials, the results are: 83 studies found for: tuberculosis AND antibiotics | Interventional Studies | Phase 2, 3. If I was going to speculate, I would look at Linezolid as a next possible addition to the TB rotation of drugs. BTW, if you change the search keyword from "antibiotics" to "amikacin" you get one study - the Arikace bronchiectasis study that has been completed.

    TB is as far away from INSM's scope of interest as Iplex is. But it is always fun to come back and see how little some posters have learned from the events of the last 12 months.

    I sold my last shares two months ago, but this MB is still a curiosity. It is like entering a time warp. fud4!?!

  • insm_truth_teller insm_truth_teller Apr 4, 2014 8:12 PM Flag

    rehdvm2004
    But the Control article in the NTM clinical trial was the liposome without amikacin. That is still a pharmaceutically active moiety because it cuts the thickness of mucous . . . which allows NTM patients to clear their lungs better. There are always scientific reasons for a clinical condition. In CF patients, they do not secrete enough mucous. In infectious patients, the bacteria hide in the mucous and secrete (bacterial) excretory products that thicken the mucous. So a comparison of Arikace with non-antibiotic liposome is a comparison of amakacin-liposome with liposome. I have been saying since the merger that the liposome that envelops the amakacin has a multitude of other clinical applications for inhalational therapy. I asked WL once in a CC about that and he acknowledged same, but said (sic) we have to dance with the date that brung us! I think that is why Dr. Gupta is now leaving. She slipped up over the cancer in rats which was a no-brainer response, but LaBella and the Transave CEO fell on their swords on that one. This one belongs to Dr. G. GLTAL but the regulatory explanations are going to be challenging. They really needed to have a pathologist person closely associated with their regulatory leadership. The definition of a pathologist is a medical person who can diagnose any disease accurately and prescribe the proper treatment , , , only one day too late.EOS.
    =Forget about TB. That mycobacterium has a totally different cell wall than NTM

  • insm_truth_teller insm_truth_teller Apr 4, 2014 5:03 PM Flag

    How a control therapy achieved a significant level of efficacy against an infection when it contained no antibiotic. The point is, that if anyone follows cffDOTorg for the last 3 years because they were invested here, they would have seen the parallel development of other significant treatments for lung infections which did not contain antibiotics. But this MB has always been myopic and narrow minded. I have not seen the data, but the sound byte plays out as, "I guess Arikace was not that significantly better than the placebo." The REASON was the placebo had an important component of efficacy. Read the patent info. The liposome mimics natural surfactant in the lung which is the substance that makes the lung expand, contract and eliminate secretions with such ease that the lungs function by involuntary reflexes (the person's brain does not actively send signals, breath in, breath out). This is speculation until the data is actually out.

    But the reason I brought this up is that I am aware of the same type of event happening in the early 1970s at Baxter. They were trying to get a drug approved, Chymopapain Discase and did an extensive clinical trial. They chose a placebo that actually had some ability to soften and liquify a displaced spinal disk. Chymopapain turned out to be 60% effective, but the placebo was 50% effective. Less than one standard deviation difference. The FDA determined it was a "coin flip" for efficacy. Dr. Lyman Smith sued to get the drug back, ran a trial with a true placebo and demonstrated efficacy with the active ingredient and on efficacy with the placebo. His firm marketed the product under the trade name Chymodactin. Look it up.

    Experience trumps speculation every time

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