Mon, Oct 20, 2014, 9:31 PM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Insmed Incorporated Message Board

rehdvm2004 51 posts  |  Last Activity: 4 hours ago Member since: Oct 21, 2004
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    Dr Kim was just on Fox News.

    by bigputt1 6 hours ago
    rehdvm2004 rehdvm2004 4 hours ago Flag

    Again, a strong factor in favor of success.

    Sentiment: Strong Buy

  • Reply to

    Dr Kim was just on Fox News.

    by bigputt1 6 hours ago
    rehdvm2004 rehdvm2004 4 hours ago Flag

    If Dr. K and Inovio are successful here . . . in the face of the infectious epidemics in West Africa . . . he will be nominated for a Nobel Prize in Medicine. I have seen him several times, he is poised, accurate, scientific and knows what is going on. This Ebola outbreak was a surprise to everyone who has worked with this type of infectious agent this time around.

    Sentiment: Strong Buy

  • Reply to

    Dr Kim was just on Fox News.

    by bigputt1 6 hours ago
    rehdvm2004 rehdvm2004 4 hours ago Flag

    Yes. That is what I heard. Not that the trial was accelerated because he would have to name a regulatory agency that accelerated the trial (FDA, EMEA, or other internationally recognized regulatory agency under Harmony). That lays to rest the post this morning that Inovio was accelerating and would start this year. (People want to hear what they want, but investors hear stuff that is not necessarily true).

    The accelerated approval for a DNA Ebola vaccine would be facilitated if the vaccine was shown to be safe and (initially effective) in more than 70% of the people vaccinated. That is two standard deviations removed from a 50:50 success rate. But even if 50% was achieved, any regulatory agency on Earth would be urging Inovio forward. This type of result would give Inovio "Breakthrough Status" for a vaccine. All regulatory agencies would swing in behind this type of clinical trial result and be willing to provide expedited regulatory approval.

    The most important fact about Inovio's preclinical (animal) studies to date is that the immunization was effective (efficacious) in all animals tested with direct Ebola challenges. The mouse model is standard (mouse models are usually used as the batch release test for vaccines - e.g., tetanus vaccination at five dose levels and then tetanus toxin challenge at each dose level, two dose levels must show 100% survival). But the guinea pig is a bit less impressive. Though they are a slightly higher animal on the evolutionary tree, their immune system is 4 times more sensitive than a humans. Thus, guinea pigs produce huge amounts of antibody from just one immunization and would have a "falsely elevated ability to fend off a viral challenge" from other mammalian species. I would like to see a preclinical trial in monkeys, specifically Rhesus or Cynomolgus Monkeys which are the actual hosts for the highly transmissible form of Ebola to humans (i.e., Simian Hemorrhagic Fever).

    So GLTAL. The future is at hand.

    Sentiment: Strong Buy

  • Reply to

    INO Announcement

    by sacbunt306 12 hours ago
    rehdvm2004 rehdvm2004 12 hours ago Flag

    I have looked on the Bloomberg website (most recent is on Ebola drugs), looked on the Inovio website and listened to several news casts this AM. None support your statement. If you are pumping, you just hurt things by serving up baloney. Thick or thin, baloney is baloney. If we find out you are serving baloney . . . iggy forever!

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    African Fruit Bat Immune System

    by videoctr Oct 18, 2014 6:28 AM
    rehdvm2004 rehdvm2004 15 hours ago Flag

    There are many viruses in domestic or wild mammals that are not transmissible to humans because they are "host adapted" viruses. They circulate among that particular species, but seldom are transmitted to another species (i.e., laterally transmitted). Vertical transmission is usually done at birth or during nursing. Anyway, humans do not get dog or cat viruses even though these animals are pets and might be in someone's home and shedding virus. Viruses are usually host specific and even cell type specific. The other thing that viruses do is adapt to the host and become less virulent and pathogenic. If a virus kills a hose rapidly, the virus dies with the infected person . . . unless there is an autopsy performed, or close contact with the person during the time of virus shed.

    By the same token, there are viruses that infect mammalian species widely. Rabies for instance. Or the many pox viruses. The encephalitis viruses of horses are spread by birds and from birds to humans by mosquitos.

    But they have a test for Ebola that can tell within 2 hours if any mammal has antibody to Ebola. So while Fruit Bats may have antibody, the virus may be transmissible among Fruit Bats, but be of low pathogenicity (not cause much disease in bats). If you look at the first cases of Marburg Virus, there was an unproven connection about a young child being exposed in a "bat cave" in Africa. Marburg is another hemorrhagic virus that infects humans rarely, but when humans get infected, it is highly transmissible and pathogenic. Remember these infected people start bleeding at the nose and around their eyes. Pretty straight forward clinical sign.

    The reason that the Fruit Bat may be a host, but transmit to humans infrequently is the infrequency of contact between the two species. Fruit Bats live in trees that are 100 feet in the air. They seldom come down to earth except when sick or dead. Besides these bats are around all the time.

    GLTAL

    Sentiment: Strong Buy

  • Any investor who believes that:
    1. Inovio's future will be determined in the next three months . . . is delusional. The concepts, patents and extensions of DNA vaccines will be around for the next 100+ years. I have been vaccinating with "attenuated vaccines", "recombinant vaccines" and old fashioned "antigen and adjuvant vaccines" for more than 40 years. That is the current state of accepted practice in veterinary medicine (hence the dvm ending to the moniker).

    But the day traders and MM wanabees that are creating negatives for the purpose of getting a weekly "stock up or down" (in order to play the share price game) are crazy.

    The concepts that founded and are expanding at Inovio will result in many new vaccines for human and veterinary infectious diseases and many human cancers. That is the way of science. But it is inherently slow and seemingly endless.

    Anyone see the PBS series on the Roosevelt's? Did not know that TRex was the beginning of the pure food and drug act. I thought it was after Dr. Frances Kelsey's stand on Thalidomide that the FDA got upgraded. BTW, she turned 100 years old in July.

    GLTAL

  • rehdvm2004 by rehdvm2004 Oct 18, 2014 9:00 PM Flag

    There are many $billions in diamonds down in the ground in Saskatchewan. Shore Gold will be in the green within one year of beginning to dig. It is a waiting game for the "Green Flag." I just saw a documentary on open pit mining on National Geo. Those guys are amazing with their gas powered earth processing equipment. Shore Gold will get loans to secure the digging operation. Then it is just whether they have picked the best spot to dig. Diamonds are used for industrial purposes now more than jewelry creation. Watch the PR go back to the "bloodless diamonds" when the digging starts.

    GLTAL

    Sentiment: Strong Buy

  • "GENEVA (Reuters) - Both GlaxoSmithKline and NewLink Genetics are working to boost their capacity to make Ebola vaccines, with a goal of a "very significant increase in scale during the first half of 2015", the World Health Organization said on Wednesday.

    Even under the best conditions, if the experimental vaccines are proven to be safe and confer protection in clinical trials, a significant number of doses will not be available until late in the first quarter of 2015, the WHO said.

    GSK and NewLink are conducting phase 1 trials in healthy volunteers currently or soon in more than 10 sites in Africa, Europe and North America, the WHO said in a statement after hosting a two-day meeting of 70 experts.

    Initial safety data was expected by year-end, with phase II trials early next year to generate more data.

    "Both companies are working to augment their manufacturing capacity. The goal is a very significant increase in scale during the first half of 2015," the U.N. agency said.

    "The next step is to make these vaccines available as soon as possible – and in sufficient quantities – to protect critical frontline workers and to make a difference in the epidemic's future evolution," it said."

    Inovio is in the same circumstances as GSK and New Link depending upon the ability to manufacture significant quantities of the vaccine for a clinical trial. So, we all hope the disease becomes controlled by a vaccine, but there is no guaranteed that Inovio, GSK-NewLink, or any other producer will win out, or that they ALL will not win out.

    Stay tuned. Idiots like druggy25 are day trader Hedge Fund wanabees.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    listen to the webcast

    by oilup12345 Oct 8, 2014 11:13 PM
    rehdvm2004 rehdvm2004 Oct 9, 2014 8:50 AM Flag

    There is a whole website that follows PD-1 investigations and news:

    https://bmsdm.secure.force.com/pd1pathway/index?TC=2009109&utm_source=bing&utm_medium=cpc&utm_campaign=awareness&utm_term=pd1&utm_content=pdiopd1_textad_Home_text_tc2009109

    The important part about PD-1 from ONCS perspective is what companies are producing a potential product that will merry-up to their Phase IIb study. Phase III studies can vary the formulation before the start of the study, but once the study begins, there can be no change in formulation. The likelihood is that ONCS is going to have to source another company that is in clinical trial with PD-1.

    Just checked ClinicalTrialsDOTgov and there are 1120 "interventional" or "Phase II" or "Phase III" studies. This should be just finding a partner who wants to sell more of their product.

    GLTAL

  • Reply to

    OK Filled the gap...

    by whyaduck Oct 6, 2014 12:56 PM
    rehdvm2004 rehdvm2004 Oct 6, 2014 4:58 PM Flag

    Sentiment: Strong Sell . . . then one hour later Strong Buy?!? Who are you fooling? Iggy

  • Reply to

    Longs should not care . . . do the math

    by rehdvm2004 Oct 3, 2014 8:17 AM
    rehdvm2004 rehdvm2004 Oct 6, 2014 10:00 AM Flag

    Because that is how long it takes to complete a clinical trial, collate the data, write the NDA or CHMP documents and file. It is a tedious time consuming process that is not for the anxious or easily tired. It takes years. But that is also predicated on the results reflecting similar clinical efficacy as seen in the Phase IIb (Phase III enabling clinical trial). Things may pick up if one of the clinical sites publishes a glowing abstract in about one year. If ARDM/Grifols has achieved "break through" results, they may get a fast track towards the trial use and maybe broader. The attractiveness of using Cipro (a very safe and efficacious drug by mouth) directly into the lungs is pretty important. It would be delivered directly to the anatomical site of infection rather than wandering through all the organs to reach the lungs. But the other attractive feature is the once per day administration that is enhanced by the liposome carrier. That is where the "value added" is present with Pulmoquin.

    GLTAL

    Sentiment: Strong Buy

  • Average shares traded per day around 15,000. SP down a buck. Net loss $15,000. No play for shorts or day traders here. Longs should just sit back and let ARDM and Grifols complete the regulatory process. It takes a long time, but is worth the wait. I bought this stock in 2013 and figured 3-5 years for maturation. Anyone figuring sooner may be lucky. Anyone figuring ARDM is a bust if flying in the face of ARDM/Grifols and Bayer of Germany which is clinically trying a twice per day solution of Cipro.

    GLTAL

    Sentiment: Strong Buy

  • Reply to

    Another big disappointment.

    by blasedp3l Oct 1, 2014 2:50 PM
    rehdvm2004 rehdvm2004 Oct 3, 2014 8:05 AM Flag

    They have Dr. Kenneth Olivier leading the NTM cause. He has international credentials. They do not need an "in house" MD.

    Sentiment: Buy

  • rehdvm2004 rehdvm2004 Oct 3, 2014 8:01 AM Flag

    In the face of an outbreak, it would probably go for 200-300% mark-up. As a prophylactic vaccination, it would go at 500% mark-up for people traveling. Remember also, the number of vaccinations to get a titer of neutralizing antibody is a factor. It might take three vaccinations to be safe. They use to vaccinate veterinary students against rabies. That was three vaccinations with attenuated duck embryo vaccine. Then they would take blood and check your antibody level. In the face of infection, they are going to vaccinate once and hope there is enough immune response left to get some extra antibody into the blood stream and save the patient. That would be therapeutic vaccination. But the preventive vaccination would go to health care workers at treatment centers, family members of the infected and people who came into close contact. The people who would be vaccinated first would be the health care workers who would be exposed to Ebola infected patients. Then they would check for blood antibody level. The important thing here is they have a way of detecting both the virus (from a blood sample) and or antibody. If you read the CDC and WHO information, once a person survives Ebola, they are likely immune for life.

    Sentiment: Strong Buy

  • while this strain of Ebola is new and has both a high morbidity (infection rate) and mortality (50%) there is no evidence that it is spread by fomites (surfaces, clothing, inanimate objects). If it was, the 1 million in West Africa would already be infected. It is spread by close contact with secretions (respiratory and saliva) that contain infected blood. Most viruses have to be protected from drying, light (UV waves kill viruses), chemicals, etc. There are lots of things people can do (use hand sanitizer or wipes) etc. It is true that if you go to a hospital or clinic, you are exposed to a higher risk of aerosol infection. Same on a plane since they took out the HEPA filters in the 1980s. But the arm of the chair would have to be covered by really moist secretions to be infective. I think that risk would be low. Besides, who in their right mind sits next to a person who is sneezing and coughing a lot? I would be more worried for the guys sleeping partner, or who he was in a closed room with while he was sneezing or coughing. But these people are identified by medical history.

    While I was the first to admit I was totally surprised about this new strain of Ebola infecting so many people (previous outbreaks involved hundreds of people) the fact that it got to a big city was a "game changer." But getting to a major city in a third world country is different than the same situation in the US.

    PS - I ran the BSL-3 Laboratory at Charles River Laboratories in Wilmington MA ten years ago.

    Let's see what happens. It appears they got this case very early before he started having nose bleeds, or blood in his tears, etc.

    Let's not over react.

    Sentiment: Strong Buy

  • Reply to

    Third Party funding for INO's EBOLA human trial

    by dwkrl Sep 25, 2014 5:10 PM
    rehdvm2004 rehdvm2004 Sep 25, 2014 5:23 PM Flag

    A "third party" is going to be one of the big vaccine producers that can manufacture 1-2 million doses per week. That would be 2 ml doses of vaccine X 2 million = 4 million mls divided by 1000 ml per liter or 4000 liters of vaccine. That is a relatively small amount of vaccine, but in terms of glass vials, rubber stoppers, aluminum caps, etc. (a vaccine vial) that is a lot of materials and labor. It would take a Chiron, Pfizer, Merck, or other large biopharma to produce that many vials. Contract manufacturers could not handle that much production. Neither Inovio or their collaborator. Then the next problem is all the electorporation vaccination units. Lots of logistical problems to solve when you start talking about millions of doses for people needing to be vaccinated.

    Sentiment: Strong Buy

  • to an expedited review. But it is going to take time. In the meantime the day traders and shorts are going to be very active in the coming weeks.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 rehdvm2004 Sep 25, 2014 5:10 AM Flag

    The challenge concerning Ebola is inoculating people who are exposed and determining the numbers who do not get infected versus uninoculated people. It is a subtraction from the "historical rate of infection" clinical trial. There is no "live virus challenge." Read more about the science. Live challenges would be performed under Biosafety Level 4 laboratory conditions in laboratory mice. Never in humans in the field. If the vaccine did not work, the protocol you just described would create an Ebola virus carrier. Do a little reading first before you make such a gross misstatement.

    Sentiment: Strong Buy

  • Reply to

    I was wrong . . .

    by rehdvm2004 Sep 24, 2014 7:39 AM
    rehdvm2004 rehdvm2004 Sep 24, 2014 4:41 PM Flag

    In response to this and similar threads below, the number 1000 is huge. But it reflects the possibility that the Phase I (single dose, one dose amount) might be "spot on" and create circulating neutralizing antibody to various mutations of Ebola virus. This virus mutates as it goes through various hosts. Up until this latest outbreak, it was an amplified virus that adapted by accident to humans as a form of Simian Hemorrhagic Fever. Now it is in 100 times more people than ever before (since Ebola, Marburg and the other Simian Hemorrhagic Fevers reached humans. I figure that if you vaccinate 1000 high risk patients (care givers and personnel around Ebola treatment centers in West Africa) and less than 50/1000 (0.5%) get the infection from providing hands-on care . . . bingo. The Phase II a would be bypassed in favor of a multiple safe dose (maybe three vaccinations) Phase II b (Phase III enabling). But if the results from giving three doses of a Phase I dose (I would guess 5 milligrams = one dose) at two week intervals gives a whopping blood titer (antibody level) . . . Inovio/GeneOne would not be able to produce the stuff fast enough.

    Remember, Inovio already has a diagnostic test to determine antibody levels that they developed for the mouse study. That is a tremendous opportunity for a diagnostic test by Chembio, BTW.

    Potential pandemics are a harsh form of serendipity.

    I just bought more shares today, so I put my $$ where my mouth is.

    GLTAL

    Sentiment: Strong Buy

  • rehdvm2004 by rehdvm2004 Sep 24, 2014 7:39 AM Flag

    because the current Ebola outbreak defies past history where it happened in a rural area with a few hundred or less exposed. Now it has made large urban areas. Different epidemiology.

    Inovio and GeneOne (the Korean partner for other vaccine projects) has the opportunity to achieve a breakthrough vaccine preparation. I just hope that the Phase I (basic safety of a single dose) is administered to 1000 enrollees. Then a Phase II a/Phase IIb with another 1000 enrollees is going to get them home under expedited FDA, EMEA and Harmony reviews. The cost of the clinical trials will be essentially the production of the vaccine, distributing it to vaccination centers in Africa and monitoring patients.

    This opportunity is unprecedented in medicine.

    Sentiment: Strong Buy

INSM
13.52+0.23(+1.73%)Oct 20 4:00 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.