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Insmed Incorporated Message Board

rehdvm2004 55 posts  |  Last Activity: 12 hours ago Member since: Oct 21, 2004
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  • posted today is for mining engineers, not investors. Shore Gold has done themselves a great disservice unless they republish this report in non-BS English, French and/or other languages. I wonder how they think they are going to get the start-up funds to proceed to open pit mining? SGF Management is out of options if they cannot publish a better report than this garbage.

    Sentiment: Hold

  • Reply to

    Regulatory response and production . . .

    by rehdvm2004 Aug 29, 2015 8:23 AM
    rehdvm2004 rehdvm2004 Aug 31, 2015 8:20 PM Flag

    I did not speculate on the potential size of the market, which was part of the question. One of the biggest veterinary products was Ivermectin (widely used parasite treatment), which was a $50 million per year market back in 1990. It is now generic which means the world market is probably twice that amount. But the use of MCNA cuts across the entire veterinary vaccine market. A quick check indicates the 2015 veterinary vaccine market to be $5.5 billion with an estimated $7.5 billion in 2020. The wholesale cost of one dose of vaccine might be $2-3 ($2.50 average). So if they add $0.25 worth of adjuvant to the vaccine to get a better T-cell response that is a 10% increase, which means the added value of the adjuvant is $550 million. Of course each vaccine would have to be tested using the adjuvant system, but that would be worth it for some of the bigger veterinary vaccine companies. That is why the Australian company wanted the rights to market IMHO.

    I did not finish the discussion on the use of Complete Freund's Adjuvant. While it give the best immunization response (it has been demonstrated to cause a slow rise in antibody level for six months) it renders the person or animal TB positive and causes a nasty scar at the point of injection (subcutaneous, intradermal of intramuscular). Both of these outcome make the use of CFA unacceptable for either human use (TB and scaring) or use in animals that have to be TB tested for shipping, or annually (zoo animals, dairy cattle, breeding cattle for meat industry, etc.).

    So if MCNA is an immunogenic/immune modulator preparation, and dose not cause either at TB false positive or a scar, it has use as an adjuvant for veterinary vaccines and/or human vaccines. The human vaccine use, however, is being slowly cornered by the biopharma groups that are developing the interleukin drugs (IL-12, and others) that are the immune system signal molecules to attract T-cells to the site of vaccination. However, these are $$$

    Sentiment: Strong Buy

  • Reply to

    Regulatory response and production . . .

    by rehdvm2004 Aug 29, 2015 8:23 AM
    rehdvm2004 rehdvm2004 Aug 31, 2015 5:01 PM Flag

    Veterinary markets are variably modest compared to human markets. First, the performance of the MCNA would have to be established. If it is a "immune modulator" (i.e., increases the immune response) it could be worth a fortune IF it does not cause a TB positive reaction. MCNA is a purified molecule of Mycobacterium phlei (Mp, spelling?) cell wall. It rarely causes disease and is treatable with antibiotics. The two other very pathogenic Mycobacterium cause tuberculosis and leprosy. The former is diagnosed by a skin test where BCG tuberculin is injected into the skin and if a "wheel reaction" occurs in 48 or 72 hours, the person or animal is deemed "TB positive" for the rest of their lives. I used the term "animals" because domestic livestock are TB tested to allow shipment over a state line. Also animals such as milking cows are tested annually so that TB is not spread by milk. So, if the MCNA is an immune modulator and causes an elevated immune response . . . guess what . . . MCNA becomes a candidate to be used as an adjuvant for any veterinary vaccine. UNLESS it causes a "false positive TB test." Just to be clear, the leading adjuvant for research production of antibodies in animals is Complete Freund's Adjuvant . . . which is a non-infectious, purified extract of Mycobacterium tuberculosis. This is why CFA can only be used in research animals (mostly antiserum rabbits) and not other research animals like goats, calves, sheep, NHPs, etc. which are tested to send them over state lines between research facilities. So let's say MCNA does not cause a false positive TB reaction . . . it might be used in not just vaccines for livestock, but any veterinary vaccine. That is why the (Australian company?) bought the rights to MCNA for veterinary use. I think the contract was for $63 million?!? It is a risk, of course, but if they get a BLA for the human use as an agent for bladder cancer . . . they will get the approval for use as a veterinary adjuvant. IMHO

    Sentiment: Strong Buy

  • Reply to

    next stop 1$

    by biotechsarehot Aug 28, 2015 2:35 PM
    rehdvm2004 rehdvm2004 Aug 29, 2015 8:27 AM Flag

    If the purified MCNA is an immunomodulator (i.e., attracts T-cells), it can be used in multiple modality therapy with other immunogenic cancer and vaccines. If the substance causes an immune modulated response but does not give a positive TB response to BCG tuberculosis, it will become a major adjuvant in veterinary medicine. I have asked and done scientific searches to find out if it give a positive TB test, but no response and no papers. This could be the reason some veterinary company bought the rights for $63 million in milestone payments.

    GLTAL

    Sentiment: Strong Buy

  • Couple of important items.

    Based upon the designated 6 month regulatory response date, it projects that a tentative approval/question date might occur in February 2016. That is just overlaying a 180 day clock onto the announcement date.

    The other important point is that TST.TO is planning their own production line for "after hours." I do not know the process, but it must be pretty straight forward if the company wants to meet the cGMP requirement in house. Mycobacterium are slow growing, but the batch size may be small enough (5-10 liters of fermentation) that enough MCNA can be isolated and purified that it is easily managed in a small laboratory. Also the fermenters and step down filters can be assembled into a single unit that rests on a 4' X 4' pallet pretty easily. I put one together for purifying chymopapain from papain. These units are easily disassembled, reassembled and sterilized.

    My sense of what TST is doing is gearing up for the human marketing. But the veterinary marketing will follow on to this filing.

    Has anyone looked into the veterinary marketing side of things? I am going to check with CVM at the FDA.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    FAST TRACK APPROVAL: EBOLA & MERS

    by lingr99 Aug 20, 2015 3:39 PM
    rehdvm2004 rehdvm2004 Aug 24, 2015 6:43 PM Flag

    It makes a difference after the results of a clinical trial are collated, statistically analyzed and submitted. Fast track gets a 90 day turn around of either approval or questions to be answered, which starts another 90 day clock when the additional data is submitted.

    Under "break through drug" "fast track review" the fastest any drug has reached market is 27 month. According to the FDA website.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    FAST TRACK APPROVAL: EBOLA & MERS

    by lingr99 Aug 20, 2015 3:39 PM
    rehdvm2004 rehdvm2004 Aug 24, 2015 6:40 PM Flag

    The standard for initiating a clinical trial anywhere in the world is largely described in the ICH (International Conference on Harmony) which standardized the criteria for making drugs, biologics and medical devices and established the sequence and scope of safety and efficacy testing (the latter is the methods by which clinical trials are performed). Your statement about stupid people reflects upon you, not other investors posting on this MB.

    Undocumented and mismanaged clinical trials in Africa for HIV infected individuals was rampant during the 1990s and became the subject of a movie, "The Constant Gardener." You have to submit a clinical trial protocol to a regulatory body in order to make sure the results are reliably accurate. You should look at the protocols that Inovio has online at their website to educate yourself before you make such a preposterous statement.

    GLTAL Iggy for bdfm.

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Aug 19, 2015 7:04 PM Flag

    If any Long was remotely affected by the dead mice bashers . . . you have more serious problems than an infectious disease . . . you need your head examined for brain malfunction!?!

    GLTAL

    Sentiment: Strong Buy

  • "WHO Guidelines document for Malaria Vaccines (but the testing principle applies to all vaccines)"
    "Methodological considerations: Potency tests for recombinant adjuvanted RTS,S vaccine"
    "In vivo potency tests"

    "The RTS,S adjuvanted malaria vaccine includes two antigenic determinants, S and CS, for which two quantitative in vivo potency assays are performed for characterization purposes. Both of these assays are immunogenicity assays in mice.

    A suitable quantitative potency test in mice is as follows. Groups of 10 mice, between six and eight weeks of age, are immunized two times subcutaneously with a 14-day interval with a series of dilutions of the reference and test vaccine using the vaccine reconstituted with the adjuvant system. The strain of mice used for this test must give a suitable dose-response curve with the reference and test vaccine. Terminal bleeds are taken when an adequate antibody response has developed. Individual sera are assayed for either antibodies to S or antibodies to CS using an enzyme immunoassay.

    The concentrations of vaccine administered to mice should be selected to permit the calculation of GMTs for anti-S response and of anti-CS GMTs. Then the relative potency of the test material is determined as the ratio of the GMT of the test sample to the GMT of the vaccine reference material. The relative potency should be within limits established by using a suitable statistical approach based on consistency data gathered on both clinical and commercial lots.

    Points which should be considered in establishing such an assay include:

     The strain and sex of mice used must give a suitable dose response to the reference and test vaccine.
     The number of mice per dilution required to meet the validity criteria of the test.
     The number of dilutions of the reconstituted adjuvanted vaccine and the appropriate selection of doses to
    be tested." (further)

    BTW, scientists are always adding "ed" or "ized" to nouns to create new verbs.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    EMA Approval Prospects

    by tycint Aug 13, 2015 7:43 PM
    rehdvm2004 rehdvm2004 Aug 16, 2015 5:29 PM Flag

    The tentative diagnosis of NTM is accomplished with pre-culture staining of acid fast cocci from a sputum sample from patients that have a dry, marginally productive cough and have a history of exposure (exposed to soils, poor quality water, other environmental factors that create soil aerosols). The acid fast staining technique takes 10-15 minutes. That creates a differential diagnosis between NTM and TB. If it is the latter, there are bigger problems and Arikayce is outside the scope of useful Rx because the cell wall lipids are different and are created differently TB from NTM. Just the facts. But TB exposure is very different. It is a people to people disease. Does not linger in the environment. Clinical history will guide the physician to initial Rx. The therapeutic fork in the road is if you get acid fast is (simply) if there is no exposure to a TB positive source, Rx for NTM. Simple. Consult the basic Dr. Kenneth Olivier papers.

    GLTAL

    Sentiment: Buy

  • Reply to

    EMA Approval Prospects

    by tycint Aug 13, 2015 7:43 PM
    rehdvm2004 rehdvm2004 Aug 16, 2015 9:47 AM Flag

    Arikayce will be approved. Questions about certain aspects of the filing are common, even with breakthrough applications. The regulators just want a question answered a certain way. 120 day clock is still pretty fast track if it is just presenting a different set of data that INSM already has, but did not present in the application or presented it in a way that was unclear. I would believe that from the data I saw and the position taken by Dr. Olivier of NIH that Arikayce for NTM will be approved by the end of the year and will be widely marketed in 2016. Just a huntch, but seems reasonable. The important aspect of Arikayce for NTM is that it will become the first choice for therapy when NTM if first isolated from a patients sputum and that with Arikayce treatment, the chronic infections and pulmonary damage from that genera of bacteria will fall way off from current levels and severity.

    GLTAL

    Sentiment: Buy

  • rehdvm2004 rehdvm2004 Aug 10, 2015 10:05 AM Flag

    Of course the scientific DD will ultimately determine the likely outcome, but the process is so complicated and slow that many investors, day traders and manipulators cannot "flash trade" and make their short $$$ quota for the day. If you go to the FDA site and look at the time to approval for a "breakthrough" filing, there are only three that go approved in less than 30 months. That is why I always apply the 3 year standard for my investments. Some sort of a clinical milestone or valuable collaborative deal has to occur to meet my projection. I bought in March 2013 and projected something would happen by March 2016. Guess what. Many things with strong beginnings have happened and Inovio is growing stronger (scientifically) and meeting milestones. My guess is there will be another two or three important steps forward by March 2016, or consolidation of a current position.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Is this a de facto merger with AZ?

    by geezerbela Aug 10, 2015 8:45 AM
    rehdvm2004 rehdvm2004 Aug 10, 2015 9:17 AM Flag

    I think there is interest both ways, but to be precise, you are correct. The INO 3112 study is their DNA vaccine against HPV with the IL-12 added to get an even stronger T-cell response. This is, in my view, the second generation of the first HPV DNA vaccine that Inovio has taken through Phase IIb. So what does this mean? Inovio has a contract with Medimmune to perform the clinical trials and manufacture INO 3112. Probably the world wide rights will follow, or are already a part of the deal. In this way, Medimmune will probably get the entire entity through regulatory and be filing for approval in three years. They will also be providing a cGMP manufacturing capability to produce millions of doses per manufacturing run and get the doses anywhere in the world the vaccine is needed. Remember, the HPV vaccine was both preventive and therapeutic. This will be the model for other preventive/therapeutic cancer preparations in the future. Inovio is not likely to be bought out over one vaccine. They will also need to make progress with their other vaccine projects with GeneOne, UPenn, etc. The focal point will be whether then next DNA vaccine really presents a "breakthrough" for some type of cancer or some type of infection.

    GLTAL Longs have outdistanced the bashers.

    Sentiment: Strong Buy

  • Reply to

    Potential valuation

    by walktheline43 Jul 31, 2015 11:03 AM
    rehdvm2004 rehdvm2004 Aug 5, 2015 9:45 AM Flag

    I think the valuation will maybe go 4X by clinical trial completion date and higher when the CF and other application clinical trials get started. INSM has been meeting most of their clinical trial milestones since 2009 and they are still in the process of completing their applications to EMEA and FDA. They are in the initial Q&A period after filing the BLA in the US, Canada and Europe. The process is tedious and protracted. No experienced investor buys into biopharma thinking the filing is "just around the corner" let alone the approval from a regulatory agency. Three years is the best you can hope for with the initiation of a Phase III.

    GLTAL

    Sentiment: Strong Buy

  • ARDM completes its study on Pulmoquin and Lipoquin in July 2016. Current status is "still recruiting." They have 255 patients to enroll. ARDM has 104 sites recruiting patients.

    By comparison, Bayer has its powdered Cipro study slated for completion in December 2016. They indicate they are trying to recruit 450 patients into their study, but they have more than 200 sites recruiting.

    This is a horse race, but the two inhaled antibiotics are different in their chemical composition. The lipid outer coat on Pulmoquin and Lipoquin makes them large enough for uptake by the fixed macrophages in the lungs which makes the antibiotic effect more prolonged. Also, many of the infections of the lung become concentrated in fixed macrophages, which are the vacuum cleaner cells of the lungs and present bacteria or foreign materials to the immune system.

    This is a horse race, but both started in April of 2014 and both are scheduled for completion in 2016.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Dengue fever DD

    by rehdvm2004 Jul 29, 2015 3:17 PM
    rehdvm2004 rehdvm2004 Jul 29, 2015 3:38 PM Flag

    Dr. Stephan Whitehead is still there and the guy working on the antibodies is Dr. Pierson. Went back and looked for references on the NIH site.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Jul 29, 2015 3:17 PM Flag

    There are two different categories of Dengue fever infectious disease - the one that causes flu/headache symptoms which is generally treated symptomatically until recovery after a week and the serious kind (1% of cases that need hospitalization and intensive therapy). If investors do their DD, they will see the value of a DNA based mAB because there are no antivirals and no vaccines for the five strains of Dengue virus. I worked at CRL years ago and we studied the five strains and antigens that Dr. Whitehead and the main guy in that NIH laboratory (I forget his name) had isolated from mosquito trappings in Asia and Central America. Dengue got to Panama in the 1990s and has been coming up the tropical coastal areas of Mexico toward the US for 20 years. This is a wide open, non-competitive therapeutic market. Watch this one carefully for the next three years.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Chembio needs to think in broader terms . . .

    by rehdvm2004 Jul 18, 2015 8:57 PM
    rehdvm2004 rehdvm2004 Jul 19, 2015 7:24 AM Flag

    The brains behind Chembio is the Dr. E who invented DPP. Worked with Chembio in 2007-2008 to get new products, one of which was a biggie. Then I sold at $4 and made $20 k which I re-invested in biopharma in Fidelity. Not a big hit, but OK. I do not short any stock. Know the regulatory path and stick it out. Usually hold for 3-5 years before any decision because of the slow regulatory path.

    As of immunotherapy for cancer, it is simple . . . many companies are going for immunomodulation and immunotherapy against cancer. The need to know what they are shooting at. Chembio has the best POC design which can be used for lots more applications than they are promoting. Infectious diseases are the old application, but you have to own the antigens and antibodies to make a killing at $4.50 per test unit. That is the overhead cost of production and if you pay a 20% royalty for the stripes on the DPP, you profit margin is down by 90 cents per unit.

    I was high on the DPP because it had more sensitivity than Luminex (a fluorescent antibody test). Did the study at CRL.

    But this is moot because Dr. Cornelia Trimble has the patent on the test reagents for HPV. Chembio should talk to her.

    GLTAL

    Name one other moniker that I use. You cannot because there are none. Iggy

    Sentiment: Buy

  • This was impossible under LS leadership. But who knows what the new scientific leadership might consider.

    An entirely new area is opening up to POC. It is the methodology associated with cancer immunotherapy. Just imagine the ability to map the therapeutic potential for a patient by a simple swab. Just like the HIV test, but for cancer. Not an infectious disease. Infectious diseases will always be recurring and changing (mutation and amplification) but cancer is being unmasked to "present to the immune system" of the patient.

    Mark my words. This is the future of therapy and POC.

    GLTAL

    Sentiment: Buy

  • Reply to

    Preview of VGX 3100 Peer Review

    by danwebs2014 Jul 18, 2015 11:07 AM
    rehdvm2004 rehdvm2004 Jul 18, 2015 4:12 PM Flag

    Forgot

    GLTAL

    Sentiment: Strong Buy

INSM
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