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  • Northwest Biotherapeutics: An Analysis Of What We Know About DCVax Direct [View article]
    You know what you are talking about.
    Dec 13, 2014. 08:37 AM | 2 Likes Like |Link to Comment
  • Generic EpiPen Could Give These 2 Stocks A Jolt Of Adrenaline [View article]
    Any new EpiPen type product that differs in any material way from EpiPen must go through the 505 (b) 2 pathway and can not achieve an AB rating. This means that it will have to build it sales from scratch as a branded product.
    Dec 8, 2014. 07:51 PM | Likes Like |Link to Comment
  • Generic EpiPen Could Give These 2 Stocks A Jolt Of Adrenaline [View article]
    I estimate that in 2014 EpiPen will have US sales of nearly $1.0 billion and by mid-2015 could reach a sales run rate of $1.2 billion. Mylan is raising prices at 20% per year and continues to aggressively market the product. Mylan has said that if the Teva product obtains an AB rating that it believes that the generic can capture 40% of the unit market. This is based on the anticipation that Teva will be the only entrant in the market for some time and will not aggressively cut price.

    I think that Teva may come in at a 40% price discount to EpiPen. With these assumptions, I think that Teva could achieve annualized sales run rate of $320 million by year end 2015 based on gaining a 40% share of the unit market. Because of the difficulty in obtaining an AB rating versus EpiPen (indeed it is not a given that Teva will be successful), it may be the case that Mylan and Teva could be the only entrants in this market for some time.

    Antares has given guidance that through sales of the auto-injector to Teva and royalties that it will achieve sales equivalent to roughly 10% to 12% of Teva’s sales or roughly $32 to $38 million if Teva’s sales reach $320 million. Antares has not given guidance, but I estimate that 60% of these revenues or roughly $22 million will be due to injector sales and 40% or $14 million will come from royalties. Assuming a gross margin of 50% on product sales, this would result in a gross profit of $11 million. The combination of $11 million of gross profits and $14 million of royalties based on $320 million of Teva sales would produce $25 million of pretax profits for Antares on an annualized basis. This is about $0.19 per share on an untaxed basis.

    These estimates as well as a complete update on Antares is available to paid subscribers of my website. The report was entitled “Antares: 2015 Could Be the Breakout Year for the Stock (ATRS, $2.24, Buy)”. The link is http://bit.ly/1yu5gyS
    Dec 8, 2014. 05:38 PM | 2 Likes Like |Link to Comment
  • Northwest Biotherapeutics: An Analysis Of What We Know About DCVax Direct [View article]
    I suggest that you read the discussion on valuation again.
    Dec 2, 2014. 08:11 AM | 3 Likes Like |Link to Comment
  • Northwest Biotherapeutics: An Analysis Of What We Know About DCVax Direct [View article]
    One of the really interesting things about DCVax Direct is that the patient could be given booster shots for a life time. The manufacturing process involves starting with a blood draw and extracting and maturing monocytes into immature dendritic cells. The resultant cells when injected into tumors pick up antigens from the tumor. Tumors mutate and become resistant to almost all current therapies. However, DCVax Direct can potentially evolve with and respond to the mutations of the tumor. Let's hope this is the case.
    Dec 1, 2014. 08:23 AM | 16 Likes Like |Link to Comment
  • Northwest Biotherapeutics: An Analysis Of What We Know About DCVax Direct [View article]
    Thanks for the additional analysis. It will be interesting/ exciting to watch the data mature.

    One of my subscribers sent me a very interesting link from IHub which you probably have seen. The link is http://bit.ly/1tuDJXe
    Dec 1, 2014. 08:14 AM | 12 Likes Like |Link to Comment
  • Northwest Biotherapeutics: An Analysis Of What We Know About DCVax Direct [View article]
    I was referring to results in KITE's CAR-T therapy in refractory diffuse large B cell lymphoma (rDLBCL) in which four patients had complete responses, and two had partial responses out of 7 patients treated. You are referring to results from 13 patients treated overall, 6 of whom had other types of cancers. In the 13 patients (including the 7 rDLBCL patients) there were 8 complete responses and four partial responses for an objective response rate of 92%. In the overall group and in the rDBLCL group the results were impressive and I did not in any way imply that they were not. The point I was making is that KITE is entering a phase 2 trial in rDLBCL which it hopes will be sufficient for registration based on impressive results in 7 patients. DCVax-L is in a phase 3 trial based on impressive results in 20 newly diagnosed glioblastoma patients. NWBO has been sharply criticized for basing the trial on those 20 patients and yet KITE has not been for basing a trial on 7 patients. I personally agree with both companies in going forward into trials that they hope each will be successful.
    Dec 1, 2014. 07:43 AM | 12 Likes Like |Link to Comment
  • Northwest Biotherapeutics' DCVax-L: A Reimbursement Perspective [View article]
    Well thought out and insightful comment as usual.
    Nov 24, 2014. 02:17 PM | 3 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock [View article]
    Wall Street analysts are essentially paid out of investment banking revenues so coverage would probably be as a result of an equity offering. They are also extremely risk adverse and would probably wait until there is validation of the technology with a success in the phase 3 trial of DCVax-L or the phase 2 results for DCVax Direct which won't be much apart in time. In the short term the answer is no.
    Nov 23, 2014. 04:41 PM | 1 Like Like |Link to Comment
  • Northwest Biotherapeutics' DCVax-L: A Reimbursement Perspective [View article]
    This article makes a balanced and good faith effort to analyze the cost of production and pricing of DCVax-L which was needed. This is in sharp contrast to the recent article written by the anonymous short seller who uses the pseuonym BioTech Hawk. It was titled Northwest Biotherapeutics Valuation =$0 The thrust of the article was that the cost of production for DCVax-L would be $100,000 and the price would be $100,000. The author's argument was incomprehensible. Yours is a better approach, but all of us have a great deal to learn about manufactruing of living cell products.
    It is probably inaccurate to compare the cost of manufacturing Provenge to that for DCVax-L but this is the only comparable living cell product in production. You correctly point out that Provenge requires three separate production runs while DCVax-L requires just one. Provenge is now selling at a list price of about $98,000 and in the latest 10-Q, the cost of goods sold ratio was 49.1% or perhaps $48,000 for one course of therapy. This suggests that each of the three production runs costs $16,000. Does this mean that the cost of production of DCVax-L at scale will be $16,000? I don't know. My contacts at companies that are engaged in living cell production suggest that the manufacturing cost will initially be in the $35,000 to $40,000 range and at commercial scale could be $25,000.

    I think that Northwest could choose to price the product on the basis of a set price per dose. If it were to be used in actual practice as in the phase 3 trials, 70% of the doses (and up to 70% of the price) would be in the first year, 20% in the second and 10% in the third. The product would probably be used until progression. I think that by 1Q, 2015 we will have some understanding of the reimbursement price in Germany and that will be helpful. The Company is currently negotiating with a number of sickness funds and can't release the results of any one negotiation as it might influence the others. I think that the price could come in anywhere from $70,000 for ten doses to $150,000. Note that not all patients will receive ten doses.
    Nov 23, 2014. 09:51 AM | 14 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock [View article]
    See the previous reply to longimgn
    Nov 21, 2014. 04:13 PM | Likes Like |Link to Comment
  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock [View article]
    The decsion to issue shares to management was a board decision and I have not been privvy to their thinking. The shares issued to Cognate are in lieu of cash for its manufacturing services. As to whether the amount is fair, I can only say that if Cognate had demanded cash instead of shares, NWBO would not have been able to continue enrolling the DCVax-L phase 3 trial or conduct the phase 1 DCVax Direct trial. Giving them shares in lieu of cash seems to be very much in the self interest of NWBO shareholders. I can't stress enough how important manufacturing is to the development of living cell therapies.

    AF has struck out on all his negative arguments on DCVax-L and DCVax Direct. His public stance is that DCVax-L is no more effective than grape fruit juice and that all of the immunological and histological effects seen with DCVax Direct are solely due to sticking the needle in the tumor. We await his more detailed thinking on this.

    If AF or whoever he is depending on is right on his biology, all of the shares of NWBO are worthless so why bother to even talk about shares being issued. And yet, his focus now seems to be on how shareholders are being screwed by through issuing shares to Cognate or management. To be consistent, he should be laughing at them for taking worthless pieces of paper. He just keeps shifting from one strawman argument to another. Look, the point is that if the DCVax-L results are positive then this stock is going to go through the roof. There also may be the possibility that this could happen if DCVax-L fails and DCVax Direct succeeds. Let's forget about AF and his obvious agenda to do everything possible to drive the stock price down and focus on the fundamental issues that will drive the stock, the clinical trials and the manufacturing that supports them.
    Nov 21, 2014. 11:55 AM | 8 Likes Like |Link to Comment
  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock [View article]
    Also, I think that availability of the property might have been a factor.
    Nov 21, 2014. 06:53 AM | 1 Like Like |Link to Comment
  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock [View article]
    Got it. I was in a tremendous rush to make a lunch in NYC and just didn't do a good proofreading. I have corrected this.
    Nov 20, 2014. 06:59 PM | 1 Like Like |Link to Comment
  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock [View article]
    You are right but there are techniques that allow firms to do this anyway.
    Nov 20, 2014. 04:12 PM | 2 Likes Like |Link to Comment
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