Seeking Alpha
View as an RSS Feed

DWD Investing  

View DWD Investing's Comments BY TICKER:

Latest  |  Highest rated
  • China's New QE Program Could Be Trend Changing News [View article]
    Chinese Ghost towns--not old towns, brand new!

    http://ti.me/1pAKnJS

    "Meant as home for one million people, the Kangbashi district remains nearly empty five years after construction began."

    It's fascinating to see what looks like a Hollywood set of brand new homes and shopping centers but with not one person on the streets, no cars, nothing. Erie.
    Apr 29, 2015. 11:33 AM | Likes Like |Link to Comment
  • Weighing The Week Ahead: Time For An Upside Breakout? [View article]
    Shorting is just beyond me and most people. Better left to hedge funds and multiple brains. Very risky,unless you have a huge margin account.

    I mean I could see shorting an equity where 20% of the float is already shorted, but even then, I'd want millions in my account to cover.

    If I had that much money, I'd be all in bonds and indexes and on a beach somewhere, not reading SA or behind a screen watching my platform.
    Apr 29, 2015. 11:30 AM | 1 Like Like |Link to Comment
  • Weighing The Week Ahead: Time For An Upside Breakout? [View article]
    We're probably not the majority though, as Mit explained.
    Apr 29, 2015. 11:27 AM | 1 Like Like |Link to Comment
  • Weighing The Week Ahead: Time For An Upside Breakout? [View article]
    Mt

    Very interesting information, and no, I would not say that is how most people handle their CCs. I just have a keen interest in keeping my money, not giving it away to banks in the form of interest. However, if I can pay 1.1% month over month for two months, I don't mind giving them 2.2% to use their money in the market to make much more than that--hopefully, anyway.

    Grim situation, indeed.
    Apr 29, 2015. 11:26 AM | 1 Like Like |Link to Comment
  • Weighing The Week Ahead: Time For An Upside Breakout? [View article]
    182

    Yes, indeed, and that's why I call the 1929 crash "The Generation Destroyer" (25 years to recover losses). You know my dad was born in 1921 and was so negatively affected by 1929 he didn't get back into stocks until about 82 years old about 2002. He got into COSTCO, went through a forward split, and got out about 2008, just before the crash, and made some nice cash. That was luck. He had no idea 2009 was going to be a disaster.

    If we have another crash like 2008 so soon after, I don't know if markets can absorb that. It might be far worse than 1929 because markets don't have the expansion possibilities they did in 1929.
    Apr 29, 2015. 11:22 AM | 2 Likes Like |Link to Comment
  • You Big Dummy, I Just Bought More Shares In Lexington Realty [View article]
    My dad loves Sanford and Son and so did we.

    You Dummy! video of "You Dummy! comments by Red:

    http://bit.ly/1GFoaEE

    Thanks man!
    Apr 29, 2015. 11:04 AM | 3 Likes Like |Link to Comment
  • Keeping Perspective [View article]
    TD

    I see what you're saying, and since inflation is lower than 1% for 2014 and looking to be the same in 2015, at least you're not losing much to inflation.
    Apr 29, 2015. 11:01 AM | Likes Like |Link to Comment
  • A Timely Interview With BioTime's CEO And His Chief Commercial Officer [View article]
    Wizer,

    What does BTX have in Phase I or Phase II currently?
    Apr 29, 2015. 10:44 AM | Likes Like |Link to Comment
  • Ocata Therapeutics To Trade On Nasdaq Global Market: Can The Bulls Finally Rejoice? [View article]
    No beef for us! I've seen this so much lately: Biotech company has Phase II driven by phase I safety and efficacy. Some have commercialized products with increasing revenue, but still are not black.

    Investors: not interested in bio-spec.

    Seems like money is pouring into profitable companies, such a Gilead and other safer equities.

    Adding to that pain is NIH not giving out grants for gene and STEM cell based research like they do for chemical research.

    It would seem currently a bad time for booth Genetic and STEM cell related biotech. It's going to take huge private equity and a big win to show the USA that STEM Cells and Genetic therapy hugely decrease suffering and premature death before money starts to pour in.

    So then you have the chicken and the egg problem--without proper funding, no STEM or Gene therapy, ever. And that's sad because those two new therapies could probably cure 99% of all diseases, maybe even 100% (virus, bacteriological, genetic diseases, including cancer, etc.).

    Bottom line: STEM cell and genetic therapy needs a big win to let the cat out of the bag.
    Apr 29, 2015. 10:41 AM | Likes Like |Link to Comment
  • If This Is A True Sell-Off In Biotech... [View article]
    AAVL

    Upcoming Phase 2a top-line readout. I believe this is gene therapy, not STEM cell related.

    Watch out below.
    Apr 29, 2015. 10:32 AM | Likes Like |Link to Comment
  • Dissecting StemCells Latest Capital Raise [View article]
    With this offering STEM will have 125M+ share float. OCAT, even with a 20M share offering, will have 55M. I think the STEM offering is .85 so 25m capital raise would be in excess of 25M shares, obviously.

    OCAT lowered its cash burn to around 5m Q/Q because currently it is not running any trails. So it's burning around 5M Q/Q right now as it gets its Phase II pivotal trials in order. I do not think they will start Phase II without a JV or other funding, and I don't think they will start it purely on dilution either.

    However, to date, all of their trials are positive. They are ready to go phase II with FDA and EU approval, where they have EU approval for a pivotal trial, and are currently waiting on the same (SPA status) trial designation by the FDA. They wanted to pivotal status for two reasons: investors wanted it and if they show efficacy, they could get to commercialization after Phase II interim data (6mnths to a year) after first injections. They are using their SMD trial since it has orphan status and from a financial point of view, has more plausibility of getting to market sooner regulation wise. I know strange, but there it is.

    Oh also, OCAT just raised 20M+ by diluting 3M shares. That means they'll be cash flush for at least a couple Q/Qs, and until the end of the year or so if they don't start the Phase II trials.
    http://bit.ly/1zkO54T

    They won't be needing money for a while.
    Apr 28, 2015. 02:22 PM | 1 Like Like |Link to Comment
  • Navidea Biopharmaceuticals: Biding My Time For Alpha [View article]
    That happens all of the time. It's just a way to divest expenses. They're executing their plan. The only options you have (barring a margin account for options and shorting) are to exit your position, buy more, or hold.
    Apr 28, 2015. 02:10 PM | 1 Like Like |Link to Comment
  • Keeping Perspective [View article]
    PGR,

    If you don't need cash for another 10 years, why in the world would you be in "cash" currently?
    Apr 28, 2015. 01:23 PM | Likes Like |Link to Comment
  • How I Learned To Stop Worrying And Love The Missing CapEx [View article]
    This is really, again, getting to the core issue of capital markets. Thanks.
    Apr 28, 2015. 01:16 PM | 2 Likes Like |Link to Comment
  • Ocata Therapeutics To Trade On Nasdaq Global Market: Can The Bulls Finally Rejoice? [View article]
    Dr. Robert Lanza, UConn Stem Cell, April 27, 2015

    Transcript from the icell crew.
    http://bit.ly/1AbIety

    Highlights:

    6. We have now successfully completed two Phase I/II clinical studies in the United States using these RPE. . .We have also carried out the only human clinical trial involving pluripotent stem cells in Europe.

    7. Obviously of course the regulatory agencies, both in the FDA and in Europe, wanted to see safety before we went into patients, so we showed that there were no safety signals, either tumors or atopic tissue in any of the animals that we studied. We studied literally over 200 of these animals.

    8. Of course if you transplant undifferentiated embryonic stem cells, you would get the teratomas, but by contrast, once they are differentiated and the telomerase is turned off, you can transplant the RPE, even if they are spiked with out to 1% undifferentiated cells, we do not see any teratomas whatsoever.

    9. Indeed, the manufacturing process does not allow that to occur. We developed an assay where we can detect even one undifferentiated cell in over a million of our RPE, and that's more than a single cell on even our highest possible clinical dose. So even if you spike in 10% undifferentiated cells made in the manufacturing process, you still don't end up with any undifferentiated cells. So that gave the FDA a lot more comfort to allow us to proceed with our clinical trials. We also got similar approval from the UK regulatory agencies.

    10. So in the United States, we had four clinical trials, Mass Eye and Ear in Massachusetts, Wills Eye Institute in Philadelphia, Bascom Palmer in Florida, and Jules Stein in California, and we had two sites in the UK, Moorsfield Eye Hospital and Newcastle (Ireland). To date, we have treated 38 patients. We are just coming up to four years on those first patients.

    11. So this just shows you the clinical trial design. Basically the dosage increases. We started with 50K cells and after we showed in three patients that that was safe, the Data Safety Monitoring Board approved us to move on. We culled the doses to 100K cells, then to 150K, and eventually to 200K.

    12. So we published the follow up of our clinical trials just a few months ago in the Lancet. We found there were no safety issues related to the stem cell treatment in any of the patients.

    13. During that follow up period, we actually found in both the SMD and the AMD patients that they had significant overall visual improvement in the treated eyes. Except for one patient, virtually all of the patients either improved or stabilized during that time period. By contrast, the untreated eyes did not show similar improvement in their visual acuity. And this just shows you an overview of the results, so this is the median visual acuity over baseline. So what you are seeing here with the dotted line is the untreated fellow eye. We treated just one eye, so the untreated eye you can see at 6 months and one year, there was no improvement in vision during that time period. . .And many of these patients, for instance, they could only detect hand motion. Within a few days they could actually start to see and count fingers. Eventually they could start reading letters on the visual acuity chart and indeed the first SMD patient that we had that could only detect hand motion, now is out over two years and can read 4 lines, 19 letters on the visual acuity chart, and she can use her computer. People can now go to the mall on their own. . . .

    14. In addition to the RPE program, we are also looking at other cells in the eyes. For instance, we have now been able to create large numbers of homogeneous retinal ganglion cells, very large numbers of these. We can also produce what we call these photoreceptor progenitors that can then go on to turn into mature photoreceptors. This just simply shows you that we get very pure populations of photoreceptors from both embryonic stem cells as well as from IPS cells. . .

    15. We also looked at the RCS rat and what we actually found is when we injected the photoreceptors into the subretinal space, again the optomotor response here in green in the transplanted animals versus the untreated animals, so there was about a doubling in the visual acuity of these animals. . . .

    17. We also are finding now, and we have some work that will be published soon, that will show that they not only have a neural protective effect, but you can actually as I showed you in the RD1 mouse, actually have blind animals. We are going in with these and actually connecting up where there were no photoreceptors initially.

    18. So moving on to another cell type in the eye, we are also looking at ganglion progenitors, because glaucoma is an aging disease that affects millions of people so we have two different animal models we looked at, the optic nerve crush, which is physical damage to the optic nerve, and another one is glaucoma models in both mice and rats. . . So the hope is that we can use these to treat patients who have glaucoma.

    20. We are also looking at other cell types. . MSCs, as you probably know, can be found in bone marrow, adipose and umbilical cords, and they differentiate into a number of different cell types, but importantly, they exert immunosuppressed effects and they facilitate tissue repair. We have actually figured out to derive these from a hemangioblast into media, and we call these cells hemangio-derived mesenchymal cells, which for short are hMCs. Obviously this is coming from an unlimited starting source of embryonic stem cells. . . There are a number of reasons we believe that these may be more potent than the usual cells that they used in clinical trials. Not only do they have better migratory properties than say cord blood or bone marrow blood, but they also have reduced levels of certain inflammatory cytokines such as interleukin-6 and because they are coming from a pluripotent stem cell source, you can create unlimited numbers that are nonvariable under GMP conditions from these cells. . . .

    25. You may be thinking, this is great, it works in mice, but will it work in humans. There was recently a study that was carried out by Walker Simon's group where they had 40 patients that were treated that had refractory lupus and they were given MSCs that were derived from umbilical cord cells. About 60% of those patients had a major ____ clinical response. In an earlier study, they actually also had a profound therapeutic effect, with long-term improvement in the disease activity, renal function and antibody levels. So you would expect from a pluripotent stem cell source like this, where the cells have stronger effect on a multitude of different immune modulatory parameters, that we would probably have even a greater impact.

    27. We also just recently carried out a pilot study in animals that had severe Alzheimer's disease . . .So the next stage is to see whether or not we can actually impact the memory of their function.

    28. I alluded to some of the differences that we are seeing in these cells, so if you compare the ES derived MSCs to the bone marrow and cord blood, you see that they have the lowest expression of this pro-inflammatory interleukin-6, which is very important for progression of diseases like multiple sclerosis. They also have higher expression of extrasoluable matrix to grading enzymes, which are important for them to get to where they need to get in the damaged tissue, and if you want to look at how fast they can migrate, you can actually peel some of the cells away and watch whether the cells can migrate so here is x0 to 6 hours, you can see the cells are migrating into that area. By contrast, the MSCs that were derived from the umbilical cord or bone marrow, you can see these are not migrating very much at all. So we think this is really a combination of lower inflammatory cytokine expression and better migratory capacity through the extrasoluable matrix.

    31. Also, as you know there is a serious shortage of platelets due to trauma, if you get in an accident. This is an ideal early candidate for clinical translation because platelets do not have any nucleus, so you don't have to worry about tumorigenicity, and one of the problems right now, if you generate platelets, they only survive a few days to 5 days, so that is why there is a shortage, because the cells cannot be preserved. What we are able to do is to turn whether IPS cells or embryonic stem cells, into these what's called megakaryocytes. These are multinucleated cells that then send out these pro platelet structures here, that then cleave off to become the platelets. And we find that these platelets that were generate, we can generate these in very, very large numbers, actually can form clots very nicely. . . So the hope is that the platelets will also be able to translate pretty soon into the clinic.

    32. So this is just the tip of the iceberg. As you can see there are a lot of different pluripotent stem cell therapies that we hope are going to be moving into the clinic in the coming years.
    Apr 28, 2015. 01:09 PM | Likes Like |Link to Comment
COMMENTS STATS
9,736 Comments
6,136 Likes