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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Apr 3, 2014 5:45 PM Flag

    Not that the science registers with posters on this MB . . .

    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.

    Sentiment: Hold

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    • This is what the data that was summarized said:

      " However, ARIKAYCE did achieve statistical significance with regard to the clinically relevant key secondary endpoint of culture conversion, with 11 out of 44 patients treated with ARIKAYCE (added to standard of care treatment) demonstrating negative cultures by day 84 of the study as compared to 3 out of 45 patients treated with placebo (added to standard of care treatment) (p=0.01). "

      But a salient point is that 3 of 45 patients on Placebo achieved negative NTM cultures in 84 days with no antibiotics. These are patient that after six months of "standard Rx" including antibiotics still had detectable NTM in their sputum and were placed in the Arikace study. Anyone care to guess what the p value would be if those 3 cases still had detectable NTM after 84 days? That would be 11cures/remissions versus 0 cures/remissions. The p value would have been in the third decimal place probably around p= 0.001.

      This continued name calling non-debate demonstrates how ignorant, barren, bereft of reason pumpers and shorts have become on this MB.

      GLTASL. INSM will get approval and go further, but the reasons will never be discussed on this MB.

      Sentiment: Hold

    • Arikace v. TOBI demonstrated non-inferiority. About the same statistical expectation for a therapeutic effect for either. Both preparations were therapeutic.

      Arikace v. Placebo (Arikace liposome without amikacin). Slight superiority for Arikace, but not a huge statistical difference. Placebos are generally inert vehicles that carry the active ingredient (amikacin) which, in turn, provides efficacy. INSM has to ask themselves why Arikace was not two or three statistically significant, standard deviations (or standard error) superior. The answer that has to be taken into account is the liposome, by itself, has therapeutic potential. Even if it is only to loosen the biofilm and mucous and allow the lungs to clear more easily. It will be interesting to learn whether or not the control group "cleared their lung more easily than when non-treated . . . just by receiving the placebo.

      But there is no rational explanation coming from the "stock broker tycoon wanabes" on this MB. Is there? Just insults against any form of scientific input or comment.

      As for numb n__ts comment about WL not responding to my question . . . I would offer the fact that INSM has hired scientists and interns to look into new formulations in the future. Think they are considering putting other drugs and biological inside the liposome?!? I do.

      GLTASL. (I added an "S" to clarify who I am addressing)

      Sentiment: Hold

      • 2 Replies to rehdvm2004
      • This is pure and utter nonsense. Who pays you to post this drivel? There was NO therapeutic value demonstrated by the empty liposome in the published press release. Again, to repeat what I have already posted.: in the placebo group on the semi-quantitative scale of mycobacterial density, 13 improved, 20 were unchanged, and 12 worsened. I would call that "no effect, but with significant variability in readings, probably inherent in this scale since it is semi-quantitative and involves some subjectivity" No QoL data have been published, so where do you get off assuming that's why the primary was not met? The real reason it was not met was inherent in the statistical definition of change in bacterial density. If you will read the press release, it states: "The objective of the primary endpoint was to show a reduction in the density of bacteria of at least one step along a seven point scale..." AT LEAST ONE POINT. That means if a treatment subject improved by SEVEN POINTS, it would count the same as if a placebo subject improved by ONE POINT the way this obviously pre-planned comparison was structured. And with the variability in this measure, it made it difficult to attain statistical significance in the number of subjects experiencing an improvement of at least one point, even though it was 18 to 13 in Arikayce's favor. As a supposed medical professional, I thought you would have instead focused on the cure rate and how it was statistically significant (p=0.01) in Arikayce's favor.

      • "Fear, uncertainty and doubt (FUD) is a tactic used in sales, marketing, public relations,[1][2] politics and propaganda.

        FUD is generally a strategic attempt to influence perception by disseminating negative and dubious or false information. An individual firm, for example, might use FUD to invite unfavorable opinions and speculation about a competitor's product; to increase the general estimation of switching costs among current customers; or to maintain leverage over a current business partner who could potentially become a rival."

        Sentiment: Strong Buy

    • 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.

      • 1 Reply to insm_truth_teller
      • It is amusing that you should hold up as your scientific paragon, this washed-up, long-winded, impertinent horse doctor. The public has not seen the QOL data, so no one knows if the liposome w/o amikacin helped the placebo subjects. We absolutely know it did not result in any reduction in mycobacterial density, which is the goal of the treatment, to address an INFECTION. To suggest that mere lung surfactant in the liposome would accomplish this is laughable. But, go ahead, keep repeating this post. It's like you're walking around with a big sign around your neck that says, "I'm stupid!"

    • 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

      • 1 Reply to insm_truth_teller
      • 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

    • Rehvdm,, I have been on every conference call since they began calls again after the strategic review and will never forget the call that you are refering to.... You had been posting here non stop about master files, and other gibberish that only apparently you understood. You used the call as your opportunity to ask WL about the master file regarding the liposome itself. To say that he "acknowledged same" is a bit of an "over statement." WL had absolutely no idea whatsoever what on earth you were talking about!!!! I'm glad you stopped back by though,, I had forgotten that there were once others here with incredible self esteem issues...

    • Robert - any idea why TEN people could have given me a thumbs-down rating for suggesting you may have been on the phone to the World Health Organisation ..... breaking the news to them that aminoglycoside injections - which the WHO has believed to be one of the very best antibiotics against TB ever since an aminoglycoside was unveiled as the first effective antibiotic against TB - are in fact useless against TB because of the cell wall?

    • Not that the science registers with posters on this MB . . .
      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.

    • rehdvm2004 • 16 hours ago Flag
      8users liked this postsusers disliked this posts9Reply
      Not that the science registers with posters on this MB . . .
      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

    • rehdvm2004 • 16 hours ago Flag
      8users liked this postsusers disliked this posts9Reply
      Not that the science registers with posters on this MB . . .
      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

    • In your opinion what are the " the regulatory explanations are going to be challenging."

      • 3 Replies to backwardpalm
      • 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!?!

        Sentiment: Hold

      • Notice he isn't here for weeks, even after the CC, then posts to add doubt about the results and doesn't answer with his opinion of the culture conversions or probably won't answer your question about the regulatory challenges.

      • 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.

        Sentiment: Hold

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