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  • Northwest Biotherapeutics Valuation = $0 [View article]
    This is incorrect.
    Sep 28, 2014. 08:30 PM | Likes Like |Link to Comment
  • Northwest Biotherapeutics Valuation = $0 [View article]
    The pricing decision has not been announced.
    Sep 27, 2014. 07:28 PM | 5 Likes Like |Link to Comment
  • Northwest Biotherapeutics Valuation = $0 [View article]
    This line of analysis is ridiculous as I have previously pointed out. You came up with a conclusion and went searching for facts or something else.
    Sep 27, 2014. 07:27 PM | 8 Likes Like |Link to Comment
  • Northwest Biotherapeutics Valuation = $0 [View article]
    Adam. You are probably not aware that treating glioblastoma starts with the resection of the tumor in all cases. Part of the tumor is sent to pathology. Prior to DCVax-L the remainder of the tumor was discarded. Now it is sent to Cognate for the production of DCVax-L. Your statement seems to imply that the surgeon has to do the surgery just to get tumor material for DCVax-L. You never cease to amaze me.
    Sep 27, 2014. 07:24 PM | 12 Likes Like |Link to Comment
  • Northwest Biotherapeutics Valuation = $0 [View article]
    You are aware that Provenge requires three different manufacturing runs because it can not be frozen. Provenge sells for about $90,000 and its COGS is about $50,000 to $60,000 for three doses. This suggests that the cost per production run is $20,000. Since DCVax-L has one production run, maybe $20,000 is a proxy for its COGS.
    Sep 27, 2014. 07:18 PM | 10 Likes Like |Link to Comment
  • Northwest Biotherapeutics Valuation = $0 [View article]
    You know that NWBO will not discuss the cost of manufacturing, virtually no manufacturer would, and this is especially the case when they are in reimbursement discussions. Yours is a contrived straw man question to make it appear that NWBO is evasive. We have seen AF using this tactic over and over. This is an integral part of the FUD strategy. Spread fear, uncertainty and doubt.
    Sep 27, 2014. 07:14 PM | 15 Likes Like |Link to Comment
  • Northwest Biotherapeutics Valuation = $0 [View article]
    I find the author’s methodology for estimating the cost of manufacturing DCVax-L to be unfathomable. He is trying to estimate the gross amount of payments made by Northwest to Cognate and then somehow determine the DCVax-L manufacturing cost per patient. Bear in mind that NWBO was extremely cash strapped until the restructuring of the balance sheet earlier this year. There was no way that Northwest could have undertaken the expense of setting up a manufacturing operation for DCVax-L and without Cognate stepping up, there would have been no phase 3 trial for DCVax-L.

    Cognate had to undertake all of the expense of setting up the manufacturing operation not only in the US, but also in the UK and Germany. This entails not just bricks and mortar but also validating all of the Chemistry, Manufacturing and Control requirements and DCVax-L. It also had to help with meeting regulatory requirements for manufacturing. Because of and only because of Cognate, Northwest has manufacturing capabilities on two continents. Remember that in living cell therapies, the manufacturing process is the product. Without Cognate, there would have been no early access in the UK or Germany.

    I find the s author’s argument so vague and specious that I won’t even bother to discuss it. His was a meaningless exercise in which he appears to have contrived the conclusion he wanted first and then made up a straw man argument to support that conclusion. This is a technique mastered from the master of straw men arguments, The Street.com's Adam Feuerstein.

    It is impossible for an outsider to make an estimate of the manufacturing cost of DCVax-L based on public financial documents. In this comment, I use a different approach and arrive at an estimate of manufacturing cost of DCVax-L per patient initially of $35,000 to $40,000 per patient in the early days of manufacturing. It is more difficult to achieve economies of scale in an autologous cell manufacturing operation, but I estimate that the ultimate cost if DCVax-L is a major success could be $25,000 per patient. My estimates are for the variable cost of manufacturing, not capital costs. Northwest definitely is not going to discuss its cost of manufacturing when it is engaged in reimbursement discussions with the German reimbursement agency. Indeed, manufacturers almost never discuss their costs for obvious reasons.

    The author didn’t even discuss the way that DCVax-L is manufactured, which is curious. It seems like this is something he might want to consider, but he is short the stock and not trying to present a reasoned and balanced approach to this issue. Here are the steps in DCVax-L manufacturing.

    When the tumor is resected, the surgeon sends a small amount of the resected tumor to the pathology laboratory. The remaining tumor mass is sent to Cognate. Previously, the patient has his blood drawn in order to obtain the monocyte precursors that are then differentiated into dendritic cells. Here is the process on a day by day basis.

    • Day 1: Tumor tissue and blood arrive at manufacturing facility.
    • Day 2: Precursors of dendritic cells isolated.
    • Day 2-7: Precursors differentiated into dendritic cells.
    • Day 7: Dendritic cells “educated” by exposure to biomarkers from tumor tissue.
    • Day 8: “Educated” dendritic cells harvested & frozen. The manufacturing process is finished. This single run yields a three year supply of the drug.

    The costs of beginning and end of this process are basically the cost of the blood draw and shipping costs to and from the manufacturing facility. Most of this is due to the blood draw and tumor sample which the hospital will charge as much as $2,000 for this. These costs overall may be $3,000.

    How do we estimate the cost on days 2 through 8? These are primarily the labor cost and chemical costs needed in manufacturing. On my own, I have no idea and I am sure the author doesn’t either. There are two other manufacturers of living cell therapies, Lanza and PCT subsidiary of Neostem. Both have extensive experiences with this type of manufacturing. I used my sources to try to get an estimate of the day 2 to 8 costs from these two companies. This was third hand information. Based on this, I came up with my previous cost estimates. There is the potential for significant error in these numbers but all of my sources felt that the author’s estimate of $100,000 was off the wall and dramatically too high.
    Sep 27, 2014. 06:37 AM | 24 Likes Like |Link to Comment
  • Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long [View article]
    The protocol is not a public document.
    Sep 25, 2014. 05:49 PM | 2 Likes Like |Link to Comment
  • My Dialogue With Adam Feuerstein On Northwest Biotherapeutics [View instapost]
    Could be.
    Sep 25, 2014. 05:48 PM | Likes Like |Link to Comment
  • My Dialogue With Adam Feuerstein On Northwest Biotherapeutics [View instapost]
    It does make one pause. His ardor can't be attributed to a search for truth. In fact, truth and balance are irrelevant to him. He wants to destroy the stock and he has certainly wreaked a lot of damage. Is it because he hates Linda Powers who he has never met or spoken with or is there some other reason? It is a mystery waiting to be solved.
    Sep 25, 2014. 02:32 PM | 1 Like Like |Link to Comment
  • Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long [View article]
    This resizing was prespecified in the ptotocol.
    Sep 25, 2014. 09:34 AM | 6 Likes Like |Link to Comment
  • Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long [View article]
    Northwest Biotherapeutics has been granted a hospital exemption in Germany. This allows DCVax-L to be used to treat patients for five years who have any grade of glioma, not just glioblastoma multiforme. It also allows treatment of lower grade gliomas, both newly diagnosed and recurrent. This is a major validation of the promise of the technology.

    The applicable law for the hospital exemption program went into effect in the summer of 2011. For 2 ½ years there have been numerous applications submitted. However the Paul Ehrlich Institute (the German equivalent of the FDA) has only approved three products. Two were products which were on the market prior to the passage of the hospital exemption and were grandfathered. These were non-systemic products used in regenerative medicine. DCVax-L is the first product to be approved that was not grandfathered. It is the first immune therapy approved by PEI, the first systemic therapy (the two German products were regenerative medicine products) the first cell therapy product, and the first product approved for a non-German company.

    DCVax-L also received a separate and quite favorable approval from the central reimbursement authority in the German system. This is another validation of the technology. Under the hospital exemption, NWBO is not allowed to request reimbursement, only hospitals can apply. The investment significance and still another validation of the DCVax-L technology is that six major hospital centers applied for reimbursement of DCVax-L.

    It is extraordinary for a product that is still in clinical trials to be approved for reimbursement. It is unheard of for a product to get reimbursement while still in clinical trials. The usual reimbursement path is to finish the clinical trial, gain regulatory approval, introduce the product and then seek reimbursement. This is a process that takes one to two years.

    Before reimbursement is gained the hospital has to request and negotiate reimbursement on a patient by patient basis. With reimbursement, each patient treated is reimbursed at a set price negotiated with the payor. With the hospital requesting reimbursement, NWBO can now negotiate the price with the health care plans. This is all while the phase 3 trial is not completed. This process is tantamount to receiving full approval and full reimbursement as would be the case with a newly approved drug. The only difference is that NWBO cannot directly promote the drug, but with the high awareness of glioblastoma patients and physicians, not much promotion will be needed.

    Some bloggers have stated that this is just compassionate use and on tweeted “compassionate use, who cares”. This reflects lack of understanding of the German system. The first difference between the older compassionate use system (commonly referred to as named patients) is the number of patients that can be treated. With named patient compassionate use, only one patient can be treated at a time. The specific patient has to be named and the physician or hospital has to prepare a regulatory document comparable to an IND. Moreover, it is usually restricted to patients who are ineligible for approved drugs or drugs in clinical trials.

    Then you have to seek regulatory approval for just that one patient and for each subsequent patient the process has to be repeated. In contrast, the hospital exemption allows the treatment of all patients with newly diagnosed and recurrent gliomas (not just newly diagnosed glioblastoma). Hospitals do not have to prepare paperwork for each individual patient. Moreover, the hospital exemption allows them to do this for five years. At the end of five years, they can apply for another five years.

    The second difference is that under compassionate or named patient use, the payor, hospital or patient cannot be charged. Under some conditions, the drug sponsor can seek reimbursement for cost incurred. Very importantly, NWBO will be paid a price which is in line with that usually given for important new cancer drugs; they are usually priced at $50,000 to $100,000 per course of therapy. And of course, DCVax-L will receive reimbursement in the same way as a drug approved through the normal regulatory process.
    Sep 24, 2014. 09:44 PM | 10 Likes Like |Link to Comment
  • Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long [View article]
    This is not compassionate use. This is early access. You will see the difference in coming months.
    Sep 24, 2014. 07:30 PM | 7 Likes Like |Link to Comment
  • Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long [View article]
    “As the Company has stated clearly and specifically in its public announcements, the DMC has not conducted any efficacy analyses and the DMC has not provided any access for the Company to any clinical trial data,” commented Dr. Curt Furberg, Chairman of the DMC. “The DMC adheres to established clinical trial monitoring procedures and does not release any data while the trial is ongoing. This is an important issue, and it is surprising and troubling to see inaccurate claims being made by commentators who seem to lack a fundamental understanding of clinical trial monitoring. I have been on the DMCs for more than 60 clinical trials, and I have never experienced this type of attack.”

    This was from this NWBO press release. http://bit.ly/1v10PZ6

    Dr. Ferberg doen't think very highly of you and I think that based on your continued hammering on the point that the efficacy analysis has been done and in your words was buries that you beleive that the Chairman of the DMC is lying. Hmmmm
    Sep 24, 2014. 07:28 PM | 10 Likes Like |Link to Comment
  • Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long [View article]
    The chairman of the DMC has said that there was no interim efficacy analysis performed. There was a resizing of the trial and this affected upwards the number of events needed to trigger an interim efficacy analysis.
    Sep 24, 2014. 03:30 PM | 7 Likes Like |Link to Comment
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