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Insmed Incorporated Message Board

rehdvm2004 143 posts  |  Last Activity: Dec 24, 2014 9:32 AM Member since: Oct 21, 2004
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  • Reply to

    Arikayce in own manufacturing facility?!

    by liv4ucf Dec 10, 2014 11:11 AM
    rehdvm2004 rehdvm2004 Dec 11, 2014 4:10 PM Flag

    This is just a natural progression from a CMO to their own space. It proves that INSM has a 5 year plan and beyond. They will just transfer the equipment and cGMP processes from the CMO. They want to have their own liposome manufacturing facility to develop more inhalational drugs.

    Sentiment: Buy

  • Reply to

    FDA Timeframe

    by tx.farmer Dec 10, 2014 10:01 PM
    rehdvm2004 rehdvm2004 Dec 11, 2014 9:18 AM Flag

    Phase IIa is escalating dose safety. Phase IIb is an efficacy study of (usually) the maximum dose that showed safety from the Phase IIa. The Phase IIb is called Phase III enabling. Usually it is a small group 50 - 100 patients that can be enrolled in the Phase III, or in some conditions where there is no currently effective treatment, patients who have no alternative can be rolled over into a Phase III. Usually the patients who are chronically affected by a condition are very sick and the safety criteria from the Phase IIa are really tested.

    All the definitions are over at ClinicalTrialsDOTgov in the glossary of terms.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Sale of CBST to Merck

    by rtcpl35 Dec 8, 2014 8:57 AM
    rehdvm2004 rehdvm2004 Dec 10, 2014 6:21 PM Flag

    There is more to patents than the letter of the patent. There is proprietary knowledge of "how to" actually achieve the endpoint that is usually secret to the original patent. Patents are a scientific point in time that lead to the next (slightly different) point in time and patent. I have 7 patents BTW which were valuable until they were bypassed.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Dec 10, 2014 6:18 PM Flag

    I have a standing "Buy" order with ARDM to purchase shares at $7.?? and have picked up 337 shares in the last 10 days. Pick your limit and gain little by little.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Conference call

    by mlbull34 Dec 10, 2014 9:35 AM
    rehdvm2004 rehdvm2004 Dec 10, 2014 11:55 AM Flag

    The regulatory requirements are as follows:

    1. Hutchinson has to have a Human Investigation Research (Clinical) Protocol approved by their IRB (Investigative Research Board) which is required to approve any clinical activities before one human is injected. The basis of this would be the already approved Merck drug coupled with the ONCS drug. This is a Public Health Service Policy requirement. This information is public record based upon informed consent to any patients who would undergo this therapy.

    2. The protocol has to have been negotiated with the FDA in order for it to be listed as a Phase IIb (Phase III enabling). This is in confidence, but will probably appear on ClinicalTrialsDOTgov sometime soon.

    3. Any negotiated criteria between Merck and ONCS is private to both parties (and probably Hutchinson administration because they have to handle the $$$ from any patient subsidy), but it is not an SEC requirement for a research collaboration. As the person in this thread suggested, it would be important for people commenting to understand the differences between a collaboration, contract and subcontract, plus throw in an understanding for an MTA (Materials Transfer Agreement).

    But the types who blurt out junk on this MB are just trying to get investors to rise or dive for the bait!

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Why are the LOW LIFES here??

    by irishmick8299 Dec 9, 2014 3:12 PM
    rehdvm2004 rehdvm2004 Dec 10, 2014 9:28 AM Flag

    Do the math. With 1 million shares traded per day and $0.40 fluxuation, that is $400,000 in short money. That is why this situation is occurring. So it is about $$$ on a daily trade basis, not the science or medicine, which takes years to prove. But if you believe in this company, you have to be Long or play the shorting game up and until the regulatory milestone is announced. There are no third alternatives.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Dec 10, 2014 8:35 AM Flag

    I see this thread is drawing flies!

    The announcement about the resurrection of the head and neck study at UCSF is important because this sounds like a compassionate IND approach. With the statistic of 500,000 new cases (it does not say that, but that is how NCI reports data) and 300,000 deaths per year (higher than Ebola mortality) that is why ONCS is going after this cancer in collaboration with UCSF. If they can even make a dent in that cancer and find other additive or synergistic drugs to develop a multiple modality approach, they may start improving the prognosis (listed by NCI as poor, BTW) by lowering that death rate. Anyway, it is a rekindling of an approach to an almost impossible cancer.

    But with 20 patients plus 11 being the goal, it will still be about a year to accrue most of those patients. We shall see.

    GLTAL

    Anyone hear from Melanoma Man? I hope he is among the patients that is out at least a couple of years. Nice gentleman.

    Sentiment: Strong Buy

  • Reply to

    SP is fluxuating up . . .

    by rehdvm2004 Dec 9, 2014 3:05 PM
    rehdvm2004 rehdvm2004 Dec 10, 2014 8:23 AM Flag

    You should really try to do some Internet research before you start doing cost analysis. Go to the "infomine" (info mine) website an look at cost models. The cost per ton for operating an open pit mine is $1900 and change per ton. Yes they need equipment, access roads and power, but those commodities are for rent. With an estimated $50 billion in the ground, with most of the active open pit mines being in Canada, how difficult do you think it is going to be to get a group with equipment to partner!?! The point is there is an estimated valuable resource in the kimberlite tubes in northern Canada, SGF has the rights and they are on the cusp of approval. EOS.

    I would agree that the current administration has been slow to come up with a plan, but the regulatory environment is intense. I have written two Environmental Impact Statements for the FDA in the US. One for producing Limulus Amebocyte Lysate from horseshoe crabs for a diagnostitest and one for a blood substitute that is made from cows blood at a slaughter house (Oxyglobin). But these EIS documents were buried in a BLA and NDA, respectively. Actually the BLA took no time at all for approval.

    So what specific points in the EIS that SGF submitted do you disagree with? I read the document. It seems very thorough and had to go through various environmental groups commenting, Native American groups commenting, etc. So what is your point other than you do not like the slowness of the process or some of the people. I would not imagine that the remaining (few) leaders of SGF were very astute at regulatory affairs. Or smart enough to have a group like "infomine" write the documents for them. They were operating on a shoestring the last few years.

    So again, do you have any constructive comments or facts that you would care to relate?

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Dec 9, 2014 6:00 PM Flag

    That study was doomed to failure because those cancers occur in a (relatively massive tissue site) in the middle of a tonsil that is 2 cm in diameter when it gets inflamed and the incited T-cell response does not know which cells to attack. Tonsillar tumors are "debulked" and then treated to establish clean margins.

    So the science and medical side of the new, intracutaneous Rx for SCC is the equivalent of the protocol for MM. It (hopefully) has the same prospects for success.

    GLTAL

    Sentiment: Strong Buy

  • First of all no one in their right mind is going to invest in a "no product/mid stage product development" biopharma who is not going to wait at least 3-5 years for the first product to get regulatory approval. It just is not the sector for that type of investment. Even the biopharma that get designated "breakthrough product" (no currently approved competitive product) take 27-28 months for approval. There have been three products out of 100s to achieve that right of passage. Go to the FDA website and look up the "expedited regulatory review" products that took less than 36 months.

    Secondly, the MM progress is reasonable. It now depends upon whether that 500 microgram per electroporation dose is what appears in Phase III and the collaborative Phase IIb with the Hutchinson doctors. Keep your fingers crossed.

    But my real interest was in the squamous cell carcinoma clinical trial for two reasons:

    1. Unlike MM (which I have had twice in situ and once invading that had to be caught by Mohs surgery), squamous cell carcinoma can grow up nerves into the cranium. I had one of these little devils over my left eye orbit. The biopsy was "hot" and the thing doubled in size within one week after the biopsy. The surgeon who took out the primary thought he got it all on one surgery. The frozen sections were negative. But the stained sections showed "fingers of swirling carcinoma cells beyond the margins." Over the eye, there is not much room between the skin and the bone. Hence back in they went and scraped the bone. They got it all. But the surgeon, radiologist and internist who worked up my case at BIDMC said, "You know this type of tumor grows up peripheral nerves and can get into your brain." That was news. So anything that makes a dent in SCC is good news of any kind.

    2. While I have not seen the protocol on ClinicalTrialsDOTgov yet, it is an improvement over the attempted treatment for desquamating carcinoma of the tonsil which was the previous study

    Sentiment: Strong Buy

  • Reply to

    Amazing how this

    by cruizon Dec 4, 2014 9:53 PM
    rehdvm2004 rehdvm2004 Dec 9, 2014 3:10 PM Flag

    In both directions!

    But the truth is that INSM should be much higher based upon the NTM progress alone. What is going to happen is that NTM diagnosis is going to improve (someone will do a POC quick test) and then lots of people will get treated very early in the disease. NTM causes chronic lung damage from slow onset, persistence, resistance and ultimately progressive lesions that go from microscopic to focal tissue to anatomical scarring. One has to understand the disease before you can project the potential value of the clinical trial.

    Sentiment: Buy

  • Maybe Saskatoon is going to respond soon! Lets hope so.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Dec 9, 2014 2:31 PM Flag

    What you say makes no sense. It should be placebo plus ImmunoPulse versus immunotherapy plus ImmunoPulse. The way you described it the first arm would be placebo and immunotherapy administered together. ImmunoPulse is electroporation. You must be from Rhodesia.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    This MB demonstrates living truth . . .

    by rehdvm2004 Dec 8, 2014 3:21 PM
    rehdvm2004 rehdvm2004 Dec 8, 2014 3:25 PM Flag

    Like is said in March 2013 . . . I am waiting until March of 2016 to make any decision to move away from this investment. It is not a loss until Inovio gets to a significant milestone associated with a clinical trial or submission to the FDA. Partnerships are an obvious milestone because Inovio does the R&D and relies on big pharma for manufacture.

    GLTAL

    Sentiment: Strong Buy

  • that 93% of Americans are "scientifically illiterate" and that the vast majority of these individuals participate in the Inovio MB and other MBs. They should have the fortitude of their convictions to reject any post exposure or post diagnosis treatment of any condition they might develop with any Inovio treatments. Therefore . . . there would be a lot less bashers in the future! EOS.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    An interesting thought...

    by every1justgetalong Dec 7, 2014 5:26 AM
    rehdvm2004 rehdvm2004 Dec 8, 2014 7:30 AM Flag

    What Merck is doing is collaborating on the probability that multiple modality (treatment) approaches will be the best treatment for MM, just like it is for other cancers. What they will be doing is hitting MM from two different anticancer cell metabolic mechanisms. The immune system part will have minimum toxicity potential which is best in cancer patients who debilitate from treatments as well and the offending cancer.

    GLTAL

    Sentiment: Strong Buy

  • The focus on defining the extremely broad genomic basis (mutation variants) of different cancers is the most valuable and ambitious. I know of several big companies in the Boston area that are collaborating on this form of diagnosis. Specifically looking at bowel cancers. The diagnostic machine is very futuristic where a patient sample can have mutations pin pointed. This diagnostic capability will alter cancer diagnosis and therapy in the future. Hope he realizes he has to release this device in stages. If you take any cancer from anywhere and put it on a test plate and get a diagnostic answer, how many repetitions before the FDA, EMEA or other says, "OK you can diagnose any cancer." Millions.

    Then retrofitting the most optimum treatments back to those cancer mutations is very plausible and is the basis of new cancer drug research. Companies are using in vitro techniques first and then tumor bearing mice to prove these treatment methods.

    His being an advocate of targeting treatments and giving smaller doses (maybe focally when possible) is spot on also. That is the multiple modality approach.

    But his presentation on immune modulation and the demonstration of the T-cell "eviscerating" the cancer cell in vitro was spot on for Inovio investors. The methods used by Inovio are going in this direction.

    While this guy is obviously a genius and has the $$$ to pursue his ambitions, even partial successes will help cancer patients. Like he said, he wants the ability to diagnose cancer within 24 hours, determine the mutations and use the best anticancer therapies in small doses for as long as necessary.

    His poster child is the guy with pancreatic cancer that is out two years from this type of therapy. I had a friend die from this cancer. He lived 6 weeks from the time he first urinated blood and was diagnosed.

    GLTAL

    PS - It is about live mice which would otherwise be dead that is the basis of curing cancers.

    Sentiment: Strong Buy

  • Clarification of events by experienced investors and technical types that provide useful information to other investors (usually retail) who might want to invest. Clarification might include (but not be limited to) explanations about the science or technical basis of the company, opinions on the importance of events, substantiation of milestones achieved and what they might mean in terms of ultimate success of the company, and the like. What take away messages seldom mean is whether an investor should "short" term sell (or buy a stock). Anyone who believes the biopharma industry is not a multiple year investment should invest in commodities and take the chance that something will happen within a year. Bashers, day traders and MMs want to "create the sensation that the Good Ship Lollypop" is sinking or will rise from the bottom of the ocean like a (dry) cork! If you invest in Inovio, realize they make DNA vaccines which require long excursions into reproducible science that take longer to explain to regulators, which when the accumulated evidence becomes undeniable result in an NDA, NADA, BLA, DEA or other regulatory approval that allows commercialization. Question: Why do you think the cost of these new treatments is so high? Answer. Because it takes so long to gain approval that $millions in developmental costs have to be attached to the product for years until ultimate profitability is achieved. The average cancer drug (not biological) takes 14 years to gain approval and $billions now a days. Go to the FDA site and do your own DD.

    SEC regards MBs as blogs anyway. These bashers who deny any relevance to improved science and/or medicine in order to get people to participate in a game of money changing are her for the day . . . not the long term benefit to improved medicine, the advance of human knowledge or anything akin to those meaningful accomplishments for humans.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Updates from Phase 3 ????

    by jackfromferndale Oct 9, 2014 12:53 AM
    rehdvm2004 rehdvm2004 Dec 6, 2014 10:45 AM Flag

    What Longs can hope for is that one of the clinical investigators has such success that they publish an abstract on their data (alone), or that during an interim review of data, the Study Director has several clinical investigators combine their findings and do an abstract. But in either case, the abstract would be submitted to the FDA as interim data prior to the final abstract publication at a medico-scientific meeting. If you publish data that the FDA does not see first, they get awful disagreeable. I had a young Ph.D. that did just that back around 1976 and my boss at Baxter called me in and asked why I was not mentioned as an author and why the abstract was submitted before the data had been submitted in behalf of our FDA filing. It was for a plastic solution and blood bag material called PL-146 and we did a teratology study to show that leachables from the plastic could not cause mutations in utero.

    Anyway, the good news about Pulmoquin is that it is the safest fluoroquinolone antibiotic (fewest side effects) for inhalational use.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    HNBE-01 and HNBE-02 post by dummy25

    by rehdvm2004 Dec 5, 2014 4:41 PM
    rehdvm2004 rehdvm2004 Dec 5, 2014 4:53 PM Flag

    The moral of the story is:
    1. Get diagnosed early via regular check-ups. As far as tonsilar cancer is concerned, anyone notice how the dental hygienist grabs your tongue and looks at your entire mouth in the last 10 years?
    2. If you are diagnosed with any form of cancer, shop hard for the best doctor in your area who specializes in that cancer or get a plane ticket to an Comprehensive Cancer Treatment Center.
    3. Make sure you get a medical person advocate (nurses are pretty good) who goes with you to screen the doctor and subsequently follow your case.
    4. And above all, do not be influenced by dummy stock day trader types.

    There is merit in the Phase II Clinical trial for MM because OncoSec is treating early detected MM and they are getting peripheral responses from the site that is treated. That means the antitumor effect is being carried through the blood to sites other than the primary site where the tumor occurred.

    They do not accrue patients very fast because most MMs are treated in situ (where they occur) by surgery which is 99.99% effective even if they have to do Mohs. I know this one by heart because I have had two MMs cured with one surgery and one cured with Mohs (three surgeries).

    But if you have any belief in what is being reported by scientists at OncoSec and now at Hutchinson in Seattle, stick around for a few years. Something big will happen.

    GLTAL

    Sentiment: Strong Buy

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