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  • Northwest Bio down 11% premarket on temporary halt of DCVax trial in Germany  [View news story]

    How did you come up with "over 120 locations" in the trial?

    Clinical trials (your own link) clearly shows 91 locations. Of this total, three sites are labeled as "Withdrawn, three as "Completed" and eight as "Active, not recruiting" which leaves 77 sites as "Recruiting", including five in Germany and four in the UK.
    Aug 22, 2015. 12:30 PM | 1 Like Like |Link to Comment
  • Energy Recovery, Last Year And This One  [View article]
    per today's filings, Rooney is out as CEO...

    and former CFO Buehler who left the company only in June 2014 ("to pursue the next step in his career") has been nominated for a seat on the BOD...

    Ole Peter Lorentzen wants control of the company. He and his privately owned investment company (Ludvig Lorentzen AS) own 16% of the outstanding common stock.
    Jan 13, 2015. 08:49 PM | 1 Like Like |Link to Comment
  • DynaVax Technologies: The Small Cap Gem Focus Stock Of The Week  [View article]
    regarding "Cowen puts monster $60 a share price target.."

    the Cowen analyst (Phil Nadeau) simply changed his price target to $60 (from $6) to reflect the 10:1 reverse split that was effected in November of this year.
    Dec 30, 2014. 11:15 AM | 2 Likes Like |Link to Comment
  • International Stem Cell Solves Immune Rejection Issue For Significant Segment Of Population  [View article]
    The Court of Justice of the European Union today ruled in favor of ISCO and that it's core technology patent applications are not covered by the prohibition on patenting embryonic stem cells.

    link to a video of the ruling...

    This clearly is a big win for the company.
    Dec 18, 2014. 01:52 PM | 1 Like Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party  [View article]

    are you still maintaining the same outlook on DSCO following the latest quarterly conference call (11/6/14) and the Company's announcements of another pushout of the expected completion date of its AEROSURF Phase IIa trial as well as the disclosure of observations of a higher than expected incidence rate of pneumothorax in AEROSURF treated neonates compared to neonates receiving nCPAP alone?

    Nov 28, 2014. 12:30 PM | 1 Like Like |Link to Comment
  • Energy Recovery: The Pressure Builds  [View article]
    It was announced in July last year that the Carlsbad desalination plant will be using ERII's PX pressure exchanger technology.

    Please provide a link to support your assertion that this is no longer true.
    Aug 7, 2014. 06:52 AM | 1 Like Like |Link to Comment
  • Energy Recovery: The Pressure Builds  [View article]
    I noticed that Ismail Nawaz is no longer listed on the website as a member of the Executive Management Team of the company. He was specifically hired in June 2011 “to bring his extensive expertise in product development and commercialization to lead ERI’s planned expansion strategy into the oil and gas market” and was given the title of "Vice President Oil & Gas"

    To my knowledge, the company has not filed an 8K or announced this news via any press release.

    My first impression is that this is not a good sign, particularly considering the recent departure of Alex Buehler, the former CFO.

    In reviewing the management team, it looks like Borja Blanco has simply been given an expanded assignment and he now serves as "Senior Vice President for Oil and Gas Sales."

    I am also not sure what to make of the addition of Andrew B. Stroudt Jr. as VP of Human Resources to the Executive Management team. Again, to my knowledge, there has not been an official announcement by the company about this change.
    Aug 6, 2014. 06:20 PM | Likes Like |Link to Comment
  • The Case Of Northwest Biotherapeutics' Missing DMC Recommendation  [View article]
    Thanks P Man. That was exactly my point.

    Here is the pertinent "interim analysis" part from the study protocol:

    In addition to the planned interim analyses for the primary outcome, a sample size re-estimation will be performed after 80% of the 240 patients have been randomized. An independent statistician (IS) will be provided a dataset with all available primary outcomes (i.e., times to progression, death, or censoring) for the randomized cohort, without treatment group assignments. The IS will calculate the Kaplan-Meier curve for the combined randomized cohort (DCVax-L-treated and placebo treated patients). The median time to PFS (M) will be estimated from this curve. The IS will use M as the assumed median for the placebo group. The IS will then calculate a sample size assuming a median PFS of M for the placebo group, and the same hazard ratio, Type I error rate and power used in the original sample size calculation.

    The re-estimated sample size (N*) will be used to determine if a sample size modification is needed as follows:

    If N* ≤ 240, no change will be made;

    If N* is > 240 and ≤ 360, the Sponsor will increase the sample size to N*;

    If N* > 360, the Sponsor may choose to either continue the trial with a sample size of 240 or terminate the trial.
    Jun 5, 2014. 06:14 PM | Likes Like |Link to Comment
  • The Case Of Northwest Biotherapeutics' Missing DMC Recommendation  [View article]
    Here is an interesting tidbit from Linda Powers' presentation at today's 2014 Jefferies Healthcare Conference regarding the DCVax-L trial design:

    Starting at 12:50 min she said: “We also have an interim analysis just for sample size – not for safety or efficacy – but just for the size and statistics of the trial. And it is preagreed with the regulators that, if we choose, we can increase the size of this trial to even further enhance the statistics. And as I have mentioned in my presentations over the last couple of months, we are actively considering internally whether to make use of this. So, we have ongoing active consideration as to whether to add a little bit to the size of the trial to enhance it even more than what I already have described – and we are thinking about that.”

    Normally, you do not consider adding more subjects to an ongoing clinical trial (which was supposed to be very conservatively designed in the first place) unless legitimate concern has arisen that the treatment effect seen in the trial so far is not as large (or maybe more variable) than was assumed when the power calculations for the trial design were first performed based on the promising earlier stage clinical trials conducted by Linda Liau at the UCLA Medical Ctr.

    A definite red flag IMO.
    Jun 4, 2014. 05:09 PM | 2 Likes Like |Link to Comment
  • Navidea - Pipeline Restructuring Conference Call (5/16/14)  [View instapost]
    I have prepared the transcript myself.
    May 26, 2014. 04:39 PM | Likes Like |Link to Comment
  • ImmunoCellular Therapeutics: Potential Near-Term Upward Spike  [View article]
    It is also worthwhile to acknowledge that John Yu, the CSO and Founder of IMUC, together with other co-authors from Cedars-Sinai and MD Anderson published a second abstract at ASCO that focused on their off-label experience with Ipilimumab (YERVOY) in 5 patients with recurrent glioblastoma. It is listed on the ASCO website as Abstract No: e13010.

    In light of the fact that IMUC is currently conducting a Phase I trial with ICT-121 in recurrent glioblastoma, in my opinion the possibility exists that IMUC may be considering a combination trial of ICT-121 with YERVOY in the same indication down the road. The current 20 patient ICT-121 trial is expected to complete enrollment by the end of this year.

    Here is the "Conclusions" part of abstract e13010: "This single-institution case series highlights the potential use and adverse effect profile of ipilimumab for patients with recurrent glioblastoma. Though optimal dose and use of ipilimumab have yet to be defined, early immune response studies are encouraging. A clinical trial that incorporates ipilimumab treatment is planned to open shortly."
    May 20, 2014. 12:24 PM | 3 Likes Like |Link to Comment
  • Energy Recovery: Is Silence Golden?  [View article]

    Michael Fitzsimmons and you have done a commendable job at pointing out the potential upsides and risks involved with investing in ERII. Thank you both!

    Having said this, I would appreciate your perspective regarding the following two issues that I came across in my own research on the company:

    First, in reviewing the SEC filings, and specifically the 8Ks of 1/16/14 and 1/17/14, I noticed that the company removed the statement "Positive Free Cash Flow in FY 14" from its most recently filed "Investor Presentation." Why would management go through the effort of refiling an 8K (within 24 hours) for what appears to be essentially the removal of the positive free cash flow statement? Admittedly, there are a few other minor wording changes (on e.g., slide 11 and slide 15) that were introduced into the updated "Investor Presentation" but the removal of the positive free cash flow statement could be taken as a warning flag.

    Secondly, it is well known that the company has long been involved in a legal dispute with Isobarix (Leif Hauge). Last year, on 7/9/13, management released a PR titled "Energy Recovery Awarded Injunction Protecting its Intellectual Property - Isobarix's Leif Hauge Prohibited by Judicial Order from Selling Pressure Exchangers" which helped alleviate investor concerns regarding Hauge's ability to start selling his own version of a pressure exchanger (and what some might consider to be a potentially better mousetrap) into the market. In the most recent turns of events, though, it appears that the ongoing litigation has not gone in ERII's favor anymore (see e.g. here: The company has been very quite about this development and I was surprised that none of the institutional analysts asked a question on the Q4 conference call regarding this concern. What is your take on the matter?
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    Mar 9, 2014. 02:43 PM | Likes Like |Link to Comment
  • How Do You Fake 7 Of 16 Five-Year Glioblastoma Survivors?  [View article]
    Regarding the issue of cherry picking the patients, here is what John Yu said in 2011 in an SA article authored by John Eastman:

    Dr Yu: Well, it’s a one center, phase one clinical trial with limited numbers. I think what we were surprised with and what I believe a lot of investors are surprised with is how well the patients are doing. You know, for the highly educated investor, they were always critical of whether we tried to load the patients on the trial with, you know, patients that have potentially good outcomes, but we really enrolled all comers in which we could surgically resect the tumor, and so we’ve shown our pre- and post- operative MRI’s to some people that were wondering whether these were all patients with tiny tumors, and they were really surprised to see the dramatic nature of the size of some of these tumors. So clearly, you know, there’s no loading of the trial in one way or another. So I think what we’re seeing is really some pretty amazing outcomes, and we’ve tried to compare the patients with other patients on historic trials, but the only way you’ll convince people is with a large randomized clinical trial - which essentially we’re starting to do now.
    Nov 13, 2013. 11:06 PM | 10 Likes Like |Link to Comment
  • ImmunoCellular: Thoughts On Potential Outcomes For The Phase II Trial Of ICT-107  [View article]
    The Society of Neuro-Oncology meeting abstracts are available online and indicate, among other findings, a 5-year PFS of 37.5% and a 5 year OS rate of 50% in patients from IMUC's Phase I study of ICT-107.

    Long term remission over 5 years in patients with newly diagnosed glioblastoma (GBM) treated with ICT-107 vaccine: a follow up study
    Surasak Phuphanich*1, Christopher Wheeler1, Jeremy Rudnick1, Jethro Hu1, Mia Mazer1, Hong Wang1, Miriam Nuno1, Almar Guevarra1, Cherry Sanchez1, Xuemo Fan1, Jianfei Ji1, Ray Chu1, James Bender2, Elma Hawkins2, Keith Black1, John Yu1,2
    1Neuro-Oncology Program, Neuroscience Institute, Cedars-Sinai Medical Center, USA, 2ImmunoCellular Therapeutics Ltd, USA
    Nov 11, 2013. 09:23 PM | 3 Likes Like |Link to Comment
  • Lesson About The Risk-Reward Profile For Amarin Investors  [View article]

    a refereed review article titled "Eicosapentaenoic Acid (EPA) Reduces Cardiovascular Events: Relationship with EPA/Arachidonic Acid Ratio" published online last month in the "Journal of Atherosclerosis and Thrombosis" ( highlights several possible mechanisms of action by which EPA (the main ingredient of Vascepa) can reduce CVD.

    I would be interested in your take on it.
    Oct 18, 2013. 06:10 PM | Likes Like |Link to Comment