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Insmed Incorporated Message Board

rehdvm2004 40 posts  |  Last Activity: May 3, 2016 4:12 PM Member since: Oct 21, 2004
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  • Reply to

    Obeticholic acid

    by rehdvm2004 Apr 1, 2016 6:21 PM
    rehdvm2004 rehdvm2004 Apr 8, 2016 10:29 AM Flag

    FDA just recommended accelerated approval. Not all suggestions about other companies on MBs are junk. This is how I came to Inovio three years ago. You have to follow up and do the DD.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Inovio- Perfect Buyout candidate - $12-15

    by nikgats Apr 8, 2016 9:59 AM
    rehdvm2004 rehdvm2004 Apr 8, 2016 10:23 AM Flag

    Inovio is not a buyout candidate. Their collaboration contracts alone are going to carry them forward until they have multiple product launches in the coming years. One big hit with Ebola, Zika or cancer target plus IL stimulant and they become a multi$billion overnight. All you "fire sale" bashers can go somewhere else to pump other stocks and try to cause panic.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Late Breaking Abstract at AACR

    by awalkinthejungle Apr 6, 2016 10:08 AM
    rehdvm2004 rehdvm2004 Apr 6, 2016 12:49 PM Flag

    I have been a cancer patient advocate since the mid 1980s. I have been involved with cases associated with personal friends and family ranging from prostatic hypertrophy to metastatic prostate cancer during that time. Since the mid 1990s when MM had surgery at Brigham and Women's where they unzipped him from his belly button to his pubis to the last three done with minimally invasive, which includes the robotic surgery method at MGH, the side effects have gone down by multiples of 10% every five years. The statistics used to be (sic) "approximately 50% of men are going to have side effects and 50% of those (25% net) will fully recover with time. Of the 25% who never recover sexual activity (mediated through the pudendal nerve which runs on either side of the prostate), most are older and are disinterested in sex anyway." The two primary aids to sexual recovery are "pumps and surgical inserts" but who knows what additional adjuncts have been devised. The last surgical patient HF who went through minimally invasive robotic surgery at MGH had "horrible side effects" . . . he was walking without assistance in two days and had incontinence for two weeks. Holy smoke!?! The sky is falling. But he is a hypochondriac anyway . . . so go figure.

    Having been a collaborating scientist with physicians at Dana Farber for 22 years (1980 to 2002) I have seen the advent of may new therapies for cancer. While true progress is measured in years because of the need to establish safety of new treatments, as well as efficacy, progress is accelerating because of companies like Inovio turning on the immune system against cancer. But that does not mean that they are the most advanced in immunotherapy of prostate cancer. Go to CTDOTgov and see for yourself. The question that started this thread was what might the abstract represent. I placed the content of the presentation in context of the Roche decision.

    The surgical part of PC is totally correct. The latter is ???

    Sentiment: Strong Buy

  • Reply to

    Late Breaking Abstract at AACR

    by awalkinthejungle Apr 6, 2016 10:08 AM
    rehdvm2004 rehdvm2004 Apr 6, 2016 10:44 AM Flag

    The elevation of PSA followed by multiple biopsies has changed the whole approach to treating prostate cancer. The other thing is that "minimally invasive surgery" (coupled with Da Vinci robotic surgery devices) allows the surgeon to get the prostate out without damaging the pudendal nerve and have the patient walking again in two days. Tremendous progress. Metastatic prostate disease had, accordingly dropped substantially. Men are getting "fixed up" before metastases occur. If you look at the Cancer Treatment Centers of America, they portray 150-something metastatic prostate cancer patients with a 96% survival at 6 months to 31 of 150-something survival at 5 years. That is with metastatic prostate cancer not diagnosed or treated by surgery before it starts to spread. Metastatic prostate cancer used to be a "death sentence" at 6 months. My sense is the treatment success rate (for metastatic prostate cancer) will not show remarkable improvement over the CTCA data. Just a notion, but there is a reason why Roche backed out.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Apr 6, 2016 10:20 AM Flag

    Genengnews May 21, 2013:

    "Grifols Taking Aradigm Stake in Up To $116M Licensing Deal

    Grifols will take a $26-million, roughly one-third stake in Aradigm under an exclusive, worldwide up-to-$116 million-plus license to develop and commercialize the latter’s inhaled ciprofloxacin formulations (Pulmaquin™ and Lipoquin™) for severe respiratory diseases that include non-cystic fibrosis bronchiectasis (BE), the companies said today.

    Under their deal, the companies will advance Aradigm’s inhaled ciprofloxacin formulations into Phase III clinical trials in BE. Aradigm has completed Phase IIb clinical trials in BE patients with both Pulmaquin and Lipoquin. Aradigm holds an orphan drug designation for BE in the U.S. granted by FDA, with no drug now approved for treating the disorder.

    “Pulmaquin will complement Grifols existing Prolastin-C business. There is significant overlap between bronchiectasis and Alpha1 physicians and patients,” Ramon Riera, president of Grifols’ global commercial division, said in a statement.

    In addition to the stake in Aradigm, Grifols will be responsible for all development and clinical expenses up to a maximum of $65 million for the BE indication. Grifols also must pay Aradigm up to $25 million cash tied to achieving undisclosed development milestones. In addition, Grifols will be responsible for all commercialization activities, paying Aradigm tiered royalties on worldwide sales of products that use Aradigm’s inhaled ciprofloxacin formulations."

    Please note the statement that "Grifols will be responsible for all development and clinical expenses up to a maximum of $65 million." Go back through the 10Ks and add up all the clinical expenses to date. That will give the answer as to whether ARDM has one or more milestone payments ahead in 2016.

    Then look at the institutional holdings that have slowly occurred since 2013. That is a second clue to Longs.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    The EMA approval appears imminent and certain

    by rvalenti Apr 1, 2016 9:08 AM
    rehdvm2004 rehdvm2004 Apr 5, 2016 11:29 AM Flag

    The last of the 255 enrollees to the Phase III was announced in December 2015. That puts that patient on a 335 day (have not double checked) path to completion. The next steps are unblinding and collation of data, which is completed on an institution by institution basis. If several prominent institutions which participated in the Phase III complete the unblinding and collation of data (under the supervision of ARDM and probably Grifols) they can submit an abstract, or paper that can appear in public domain at an important scientific meeting. But the Sponsors (ARDM and Grifols) have the first right of refusal because they do not want any public disclosure of info that has to be submitted in confidence to a regulatory agency. It is the (time consuming) process for license approval and marketing with regulatory approval. However, as indicated, one or more of the institutions can pool data and publish if they have statistically significant results. There is also a slim chance that if the data represents a "breakthrough therapy" the regulatory agencies can give the drug expedited review and approval pathway.

    The critical parts of the Phase III were number of patients that had significant log reduction of Pseudomonas aeruginosa, if a significant number of patients went to zero Pa, how fast they went to zero Pa and how long they were refractory to re-infection with Pa.

    I would suspect something around June will indicate some milestone in the science. Of course any time Grifols pops with some cash, that means they are looking at inside data that meets one of the regulatory milestones. We shall see.

    GLTAL

    Sentiment: Strong Buy

  • After 10 years of digging a huge open pit . . . a gold mine is now on the cusp of yielding $2 billion . . . per a recent yahoo story. Shore only has to go down through 150 feet of forest loam to get to diamonds. This is a stock for legacy to grandkids.
    GLTAL

    Sentiment: Hold

  • rehdvm2004 by rehdvm2004 Apr 1, 2016 6:21 PM Flag

    ICPT is a big deal. The created a "semi-synthetic bile acid" which inhibits certain liver disease processes. This is exactly what Inovio is doing for infectious agents and cancer. Creating synthetic vaccines to interfere with disease processes. However, the ICPT stock price is $130, not $485 per the poster on this MB.

    So Longs . . . there is great hope for a super SP for Inovio stock because their potential product scope is almost unlimited. EOS for the bashers.

    I had 10,000 shares in 2013, took the RS and worked my way back up to 8,500 plus shares. Knew I had to wait, but the wait is paying off. According to my Fidelity Account, I am up $40,000 over what I paid in to re-establish my holdings. That makes this holding a great legacy for a few special kids in the future.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Yahoo Message Boards

    by edwin116 Mar 31, 2016 3:47 PM
    rehdvm2004 rehdvm2004 Mar 31, 2016 6:35 PM Flag

    Because . . . the MB strays off the relevant issues to the success of Arikayce and does the "character assassination thing." Since before 2009, certain posters on this MB attack reasonable posts about the science or regulatory approach to INSM getting approvals for liposomal amikacin. Simple as that. I just wandered back onto this MB because I thought that the SP was far below what it should be and a "rock" head posted a question about Pa CF. Then the flood gates opened and the "Donald Trump Wanabees" got involved. Stupid, ignorant, etc., etc. But this MB will not change until honest debate is the format. I got out of INSM because WL took the program to the point of the "wait for regulatory approval" position. Unfortunately, that takes years for the EMEA or FDA to respond. Same for all the other biopharmas. I am just about at the same level as you are . . . if I sign in, half the posts are ignore.

    BTW this status reflects the situation for most of the political commentary in the US right now. Robert Kennedy Jr. said (when he was running for office in the 1980s) "Americans are the most over entertained and under informed people in the world." That is because we live in a world of our own without regard to differences. Americans hate differences . . . without recognizing the differences among us.

    GLTAL Arikayce will save many lives affected by NTM in the future. And may "backdoor" an important therapeutic contribution to pneumonia, bronchiectasis, but probably not TB.

    Sentiment: Buy

  • rehdvm2004 by rehdvm2004 Mar 31, 2016 6:04 PM Flag

    Inovio has had such success with HPV that they have already created their own second generation vaccination product. This is the VGX-3112 Combo. The "Combo" part is a T-cell stimulation pathway that is triggered at the same time the vaccination for the infectious virus is triggered. Thus . . . since T-cells are the immune mediator for an immune response to the VGX-3112 vaccine . . . the response to the vaccine is enhanced. If investors would notice, Inovio has a common Phase I protocol now . . . vaccination with whatever infectious agent or cancer epitope preparation they are targeting . . . and vaccination with that infectious agent or cancer epitope with T-cell enhancer. It is a fool proof combo that would lead to one or both becoming potential vaccines. Remember . . . the only difference between a protective response to an infectious agent or cancer antigen in an immune intact person and one who is immune compromised . . . is the number of T-cells that are there to respond. Inovio has developed a method to maximize the number of T-cells available to respond. This is a foolproof therapeutic strategy.

    GLTAL (Fsabs)

    I will send a bottle of great wine to the poster who decodes the second acronym.

    Sentiment: Strong Buy

  • would even attempt to bash a company with two encouraging press releases about providing a vaccination for a (usually) lethal viral disease that periodically breaks out in West and Central Africa and a "therapeutic vaccine" that is an alternative to traumatic surgery for women at risk for infertility, cancer and systemic viral disease . . . a misanthrope! Someone who hates humans in the first place.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Why did the EMA block a breakthrough therapy?

    by arikaycerocks Mar 25, 2016 5:51 PM
    rehdvm2004 rehdvm2004 Mar 30, 2016 8:59 AM Flag

    EMA did not block the therapeutic application for Arikayce for Pa CF Patients . . . Insmed chose not to answer the CHMP questions because they could not compete with tobramycin inhalational.

    The only "rocks" in these posts are the "in the head of the person posting the "misinformation."

    And NTM is not TB. Dr. Kenneth Olivier, the guru for NTM at NIH who also dabbles in TB studies . . . used different drugs in the treatment of each different clinical condition.

    Again "rocks!"

    GLTAL

    PS - If the Arikayce disk gets onto the blood agar plate that has a sputum sample plated on it and has the biggest "zone of bactericidal activity" around it . . . guess what antibiotic the physician will prescribe? Even if TOBI, TIP, Azyrthomicin (spelling?) or whatever disks are on the plate. The diagnostic laboratory will tell the physician which one to us to treat the infection. Unless the diagnostician has "rocks" for brains.

    BTW . . . is it not strange that a former investor shows up and suggests INSM is a "buy" just a couple of days before a stock analyst group gives the same recommendation? But not in the head of someone who has "rocks."

    Sentiment: Buy

  • Put all Inovio statements which have been allowed by "peer review articles" (reviewed by scientists and physicians):

    1. Best therapeutic vaccine means that the patient can be vaccinated after being infected and the vaccination (which is localized to the cervix) eliminates the virus causing the inflammation and the lesion.

    2. In the absence of infection, inflammation and continued invasion of the cervical tissues, the anatomy starts to heal (normal tissue returns and scaring occurs). Scarring BTW is the marker of healed pathological processes.

    3. The healing process is so remarkable in some women that this form of therapeutic vaccination is considered by these same scientists and physicians to be an "alternative to partial or complete excision of the cervix" which would render the woman infertile.

    These facts are simple, easily understood and very encouraging for women in under developed countries where HPV has an significant epidemiological incidents, or in developed countries when a woman hooks up with the wrong guy, gets and HPV infection, but wants to preserve her reproductive rights.

    The vaccine is contemporarily well formulated to produce results that support women's reproductive health, well being and comfort until the next improvement in vaccine technology produces a pill that a woman can swallow and product the same result.

    EOS.

    Ignore day traders and bashers who are just trying to "fear monger" misinformation to get 1 mega shares to change hands and a 20 cent play for a day.

    GLTAL

    Sentiment: Strong Buy

  • They changed any license agreement, material transfer agreement (MTA) and clinical trial protocol. These are all specific documents for "who, what, when, why, where and how." So the "what" voided any prior agreement. That does not mean that they (the Medimmune-Inovio consortium) is not going to go back to Europe and renegotiate the clinical trial. Who in their right mind believes that they USA and Canada are going to enter into a series of clinical trials on HPV and that Europe is going to sit on the sidelines?!?

    Under the International Conference on Harmony (ICH), the leading countries in research and medicine have unified their regulatory codes to follow the same pathway to licensing. But the stock broker day traders (who have no ethics and/or code) will tell potential investors that the sky has fallen. They are Chicken Littles and all they want to accomplish is a 1 mega sell off with a 20 cent fall ($200,000 changes hands in short stock transactions). Only the naïve and idiots pay them any mind.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    This is why Inovio will succeed . . .

    by rehdvm2004 Mar 22, 2016 8:57 AM
    rehdvm2004 rehdvm2004 Mar 23, 2016 9:58 AM Flag

    I hate to make you look bad, but the point is that Inovio is now applying this technology to specific infectious disease and cancer epitopes. Inovio's technology was not invented overnight . . . Dr. Kim brought it with him from Merck. But it is the parallel development of the science of genomic mapping that has allowed this matching of genes to specific metabolic disease pathways, cancer epitopes and infectious agent epitopes. But I am glad that we agree on something . . . it is the ability to produce "neutralizing antibodies" that is the key to efficacy. "Neutralizing antibodies" means that the affinity and avidity (ability to find and stick to) the surface antigens that cause disease is the key. Polyclonal antibodies have difficulty finding and staying attached to disease epitopes. Monoclonals do not. They hit and stick.

    BTW . . . I worked for Dr. Baruj Benacerraf at DFCI. He is the guy that started mapping the mouse and human genomes in 1980 . . . the year he won the Nobel Prize.

    GLTAL

    Sentiment: Strong Buy

  • It takes 10-14 days for a vaccination/immunization to induce antibody formation through the immune system. This response is what is termed "active immunity." This vaccination/immunization period can be shortened by simultaneously stimulating T-lymphocytes (antibody response mediator cells) to be secreted the blood stream and converge on the site of immunization. This shortens the response time to less than 10-14 days. This "latent period" where there is no active antibody allows the infectious agent to multiply and cause more damage. However, if the infection is also treated with "passive antibody" (antibody created outside the infected person's body) . . . this antibody bridges the period of time before the patient's body can make "active antibody." Active antibody is associated with "immune system memory" which can recreate the antibody after a second, third or more exposure. The body protects itself based on prior exposure. Passive antibody produces no memory response.

    For this pathway described above, Inovio will pin down treatments for lots of different infectious diseases in the future. Detect the disease, treat with passive antibody while the vaccination/immunization procedure begins and in a shorter period of time . . . the patient has sufficient circulating neutralizing antibody to cause remission or cure. EOS.

    GLTAL . . . Inovio is going down a win, win path to new treatments for infectious disease. This pathway is slightly different for cancer, however, because the treatments need to be localized for maximum efficacy.

  • means that all countries that subscribe to the European Union have agreed to have one review rather than more than 20 different reviews to assess safety and efficacy. One file is submitted and the review clock starts simultaneously for all countries. They pool their review results, collate them into a final list of questions and submit the questions back to Aradigm (and Grifols as the participating partner). Answer the questions (which will probably be about manufacturing, quality control testing, etc.) and submit the answers for the final review. The point is that the questions submitted by each country are unambiguous and usually require more data or clarification/modification of a statement in the file. If those responses pass the follow-on review test . . . the EMA will be inclined to issue the license to market.

    The important part is that under the centralized review process . . . every other country that subscribes to the Conference on Harmony (NZ, Australia, SA, Japan, US, Canada, etc., etc.) will probably accept cross filing and will similarly approve.

    Grifols probably helped achieve this milestone and will be making a sustaining payment sometime fairly soon to keep the momentum. The biggie is the results at OSU that demonstrated high bactericidal activity against NTM. That is the toughest pulmonary infection, but we have Dr. Kenneth O. (last name escapes me) back at NIH to lead the way on that infection. He is the world's expert on NTM.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Mar 17, 2016 11:18 AM Flag

    The Phase IIb study of cervical cancer is listed at Clinical Trials as "Completed." If the conclusions from the study stand that HPV vaccination is an "alternative to surgery on the cervix" and perhaps more invasive surgery on the uterus, then the follow up report to the FDA should be in the final stages. The change to "Completed" is noted as verified by the FDA. This is a milestone and the results of the Phase IIb could be promoted to submit a BLA. We shall see.

    Longs need to understand that Inovio has to follow the regulatory process and maintain confidentiality for the final reports with the FDA. They cannot perform "press releases" on a month by month basis because it would represent "non-compliance" with the regulatory system that USA has adopted. Sorry this takes so long, but the enrollment of patients into a clinical trial is, unto itself, a competitive process. Look at the inhalation antibiotics competition over the last 10 years.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Mar 16, 2016 10:54 AM Flag

    I got off this MB because I thought it would be a conflict of interests. I was working with the veterinary spin off from Inovio. Unfortunately those projects are very "ill fated" because they have some pretty non-scientific and non-regulatory ideas. It is a privately held, foreign company so no excitement there.

    The last patient was enrolled in the Phase III ARDM study in December. It is a waiting game because the cycle of treatments is 340 days. So there are about 250 days left before that patient gets through the protocol. But that does not mean that the patients who are through Rx cannot have their data collated and start to be analyzed. Remember it is the "logs of bacteria killed" that was outstanding in the Phase IIb. Each "log" is equal to 10. So four logs is 10,000 bacteria per ounce of sputum. That is more than TOBI, tobramycin powder, Arikayce, etc. As soon as ARDM gets to the milestone for bronchiectasis, I think they are going to go after NTM.

    But as far as Inovio is concerned, they appear to be going slowly but that is the regulatory process under Harmony. Snail pace slow.

    GLTAL

    Sentiment: Strong Buy

  • typing in the assigned number: NCT02327468 and doing a search. There are six treatment groups of 9 patients each.

    There are three types of cancer being treated, however, which should protract the small number of patients enrolled. The study is being done at the University of Pennsylvania Medical school which gets large numbers of patients each week.

    GLTAL

    Sentiment: Strong Buy

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