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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Apr 9, 2014 12:24 PM Flag

    FDA discussions will include . . .

    Several points on Slide 6 in the investor's presentation including:

    "Reduction in bacterial density (numerically superior, not statistically significant)."

    Critical point of discussion with FDA. Frankly, I was totally surprised as a former investor and supporter of inhaled liposome amikacin that there was not a statistically significant reduction in at least 50% of the Arikayce patients, let alone 70% becoming negative in 30 days. There was just that much theoretical power behind WL's presentation. The slam dunk level would have been (minimally) 50% of patients would become NTM negative during the 84 day period. As it was, that got half that number (25%).

    "Culture conversions to negative in 11 out of 44 patients at Day 84 (statistically significant)."

    OK. Twenty-5% became negative after 84 days. But these data have to be explained in view of three Placebo patients that also became negative after 84 days. This is after they had received six months of currently prescribed multiple modality therapy and remained NTM culture positive. So what in the treatment regimen made these patients become negative when it did not before?

    If Longs listen to the non-scientific, non-medical interpretations of what happens event by event at INSM . . . you are tracking the wrong information. When Dr. Olivier speaks, it will be worth listening to because he is both the clinician and a scientist of record for this effort.

    My personal belief is now that the NTM data is in, amikacin may not have been the best antibiotic for Pa or NTM. There may be more efficacious antibiotics to be included in the liposome. That could also be why WL suggested INSM would be pursuing a partner. Perhaps one with a stronger in vitro therapeutic index to Pa and NTM. INSM still has a proprietary liposome, which is one-half the battle.

    We shall see, but the remaining Longs who are sane and not pumping are in the "Hold" mode again.

    Sentiment: Hold

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    • The entire point of this thread was obvious to anyone who knows the regulatory system of drugs.

      These data are already with the FDA and the Advisory Committee for this IND. That is the only way that INSM could release any data in an Investor Presentation, which is a public document. So what is new?

      INSM talking about a Phase III study for NTM and partnering. The previous discussions and CCs from WL all pointed to expedited review and "breakthrough treatment." Now the discussion is Phase III and partnering.

      While bwd validated my point that the liposome alone has some therapeutic effect, the data do not support a strong antibiotic effect from the amikacin. That is going to be a focal point of discussion for many months.

      This same group of posters kept saying Iplex would be a Phoenix from the ashes after the dismal MMD study results. Same #$%$ keep spouting blather. It took two years for the Transave merger to reposition INSM. They had three Phase III studies almost immediately. Then the two rats with precancerous lesions that could be explained away by any competent veterinary pathologist in an instant. But it took 7 months to get back on track, with the NTM study being relegated to a Phase II (feasibility study).

      This situation is going to go on for months before it gets cleared-up. I think that INSM is going to come up with a different treatment regimen for a Phase III, because expanding on these results will not get them to an NDA.


      Sentiment: Hold

      • 5 Replies to rehdvm2004
      • REH

        I would like to hear your thoughts on the following:

        At the March 26 presentation, at approximately the 11:40 mark, Dr. Gupta stated: "we continue to see culture conversions in the open label portion of the study, and that study is still continuing".

        At the 23:30 mark in yesterday's presentation, WL stated: "we even saw at least one or two patients coming out of the placebo arm who culture converted during the second 84 days".

        We have been told repeatedly that the majority of all culture conversions occur in the first month of treatment, and we have been told that a sizable percentage of control group patients opted to take Arikayce in the open label portion of the study.

        My question is very simple: Based on the 25% cure rate from the main P-2 study, shouldn't we expect a similar cure rate for the converted placebo arm patients and, if yes, are WL's comments consistent with that expectation?


      • If Insmed gets breakthrough status,all questions will be answered.If the FDA stalls or declines the drug could be in for lengthy delays

      • So, when WL made comments such as the number of culture conversions were shocking to the clinicians involved and that this was unfortunately not the primary endpoint because it wasn't considered possible, YOU ARE SAYING that he was lying - correct rehvdm?

      • INSM talking about a Phase III study for NTM and partnering. The previous discussions and CCs from WL all pointed to expedited review and "breakthrough treatment." Now the discussion is Phase III and partnering.
        While bwd validated my point that the liposome alone has some therapeutic effect, the data do not support a strong antibiotic effect from the amikacin. That is going to be a focal point of discussion for many months.

        Verses clowns that just spam. NO ONE knows the verdict but yesterday was clearly a shot across the bow....Perhaps those of us who shook our heads at the PR about Dr Gupta will instead hope for the best for NTM patients

        This article is NOT bashing.. Investors in bios should ALWAYS be cautious,not emotional

        from Brian Nichols:= it's a toss up to know how the FDA will react. Depending on the FDA, Arikayce could be the first approved treatment for nontuberculous mycobacterial (NTM) lung infections, but with failing reduce density the FDA's decision is really a toss-up for investors to predict.Insmed has announced that it will now seek a Breakthrough designation from the FDA, and if awarded, it will tell us a lot on how the FDA views the company's recent data, and perhaps whether or not it will ultimately be approved or not. It is this outcome and decision that investors should watch closely in the coming months. Because with an $800 million market cap, Insmed has a lot to lose

      • Did Insmed not hire you? Sounds that way. Smart move on their part. Now, go away and play with the other rats on this mb.

        Sentiment: Buy

    • One who owns no shares and posts drivel is a simple fool.

      Sentiment: Buy

    • "So what in the treatment regimen made these patients become negative when it did not before? "

      It's too funny that you need to ask that question of the NTM Control arm - after having seen the vast improvement of efficacy in the CF Control arm (on TOBI) of the EMA study over that seen in previous clinical trials and in everyday use.

    • So, you believe that the liposome - that is owned by Insmed - is the key asset and that it can be coupled with any number of products to produce positive results for a myriad of diseases and inflictions. Given this is true, you have just opened up hundreds of potential partnerships and billions of potential dollars with very little investment required by the company, ie. exceedingly high profits, much like licensing revenue in the tech/software business. You just made the case for a gold rush from partnerships. Thx for formulating this scenario which is far larger and more lucrative than most were thinking.

      Sentiment: Strong Buy

      • 1 Reply to jad9000
      • That was always the potential of the liposome. Read the patent. It included ALL aminoglycosides, floroquinolones, macrolides, etc., etc. But it also included antibodies, biological and drugs. Only one problem. For any other formulation and until INSM has its first approved product . . . the liposome is a Control Article under GLPs and FDA CMR 310 Clinical Trial regulations. A master file is for "carrier vehicles" that are proven safe, but do not necessarily have an efficacy of their own. But as I am sure posters on this MB remember, Transave did a preclinical safety study on the ability of the liposome to penetrate the biofilm and be taken up by the fixed macrophages in the lung. Anyway, it is moot because if Longs thought two precancerous lung lesions in rats caused a delay, the points I raised in this thread and that one death in the Arikayce group are going to be discussed for many months. INSM may be looking to partner to get some other projects started, or get a project started for just the mucolytic liposome. Many posters on this MB have fingers that go 60 miles an hour and brains that go less than 10 miles per hour. Thinking first is always best.

        Sentiment: Hold

    • rehd, you are full of it. No one believes you anymore. And you're conclusions are totally wrong about the clinical results, as well..

      Sentiment: Strong Buy

      • 1 Reply to jsblvbjb
      • The good doctor says they must explain the control arm results? Is there a benefit attributable to liposomes?

        Why do you think we are developing a liposomal delivery for antibiotics? We know…
        1) Liposomes stimulate the mononuclear phagocyte system (MPS). MPS plays a major role in the aspecific host defense against infection;
        2) Liposomes are very similar to natural membranes and can be administered safely. They degrade naturally;
        3) Liposomes are unable to leave general circulation on their own and are preferentially taken up by the MPS cells. So they stimulate the natural body defender, as well as deliver a desired agent;
        4) Liposomes size and surface can be constructed to reduce the uptake by MPS and prolong circulation;
        5) Liposomal delivery can be inhaled or intravenous;
        6) Liposomes can encapsulate any number of agents;
        7) Intravenous delivery of liposomes uptake by MPS occurs mainly in the Liver and spleen;
        8) Liposomal delivery of agents has been seen effective in malaria, histoplasmosis, cryptococcosis, leukopenia, and others.

        Regarding #8 and liposomes in general, one only needs to read Dr. Perkins’ bio to understand where Insmed is heading. I cannot provide the url here, but just google Walter Perkins and who will find an article where he mentions new work he is doing at Insmed.


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