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  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    I am not overly focused with the endgame at this point although it will almost certainly entail a collaboration or takeover if the DCVax drugs are successful in their clinical trials.
    Feb 11, 2015. 07:40 AM | 2 Likes Like |Link to Comment
  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    The sample size for which we have seen individual patient data for DCVax Direct is effectively one pancreatic, two sarcoma and one non-small cell lung. See this link

    http://bit.ly/1LZBdEd

    This is a very small sample. I have heard anecdotally that there has also been promising data in melanoma and colorectal cancer, but this is just anecdotal. So what conclusions can we draw from interim data on four patients. The pancreatic cancer patient results are simply spectacular. Given the severity of the other three cancers, the interim results strpngy suggest biological and clinical activity. I think that there is clear evidence of a biological effect, but is it clinically meaningful. In the pancreatic, lung and one sarcoma, the answer is yes. Is the effect durable? It is in the pancreatic cancer patient the answer is yes, but the others are indeterminate. The other very important issue is that there is virtually no impact on quality of life. Side effects are a mild fever treatable with Tylenol for two days. I anxiously await the results for the whole 40 patients.

    In regard to CAR-T, remember that we dealing with massive tumors which in the words of both patients and physicians, just seem to melt away in a matter of weeks. Use in smaller less advanced cancers may not have as severe side effects issues. I am impressed.
    Feb 7, 2015. 03:23 PM | 4 Likes Like |Link to Comment
  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    It is possible fr DCVax-L. I may be overly cautious, but this is an event driven trial and events are not predictable. For DCVax Direct, we will definitely see some type of data on eachl of the patients.
    Feb 7, 2015. 07:52 AM | 4 Likes Like |Link to Comment
  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    Provenge is really not a pure dendritic cell vaccine. It is a mishmash of cells including antigen presenting cells like macrophages and dendritic cells as well as other cells derived from monocytes. It also only targets one antigen. To me, it seems like a crude product, but perhaps there is something magical in the combinations of cells.
    Feb 6, 2015. 03:31 PM | 4 Likes Like |Link to Comment
  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    There could be synergy, but assuming that both drugs are approved it will take years to determine. Immuno-oncology is about 15 years into a development cycle that will run for 50 or 100 years. All current technologies will be seen as primitive by future generations of science.We understand so little.
    Feb 6, 2015. 03:25 PM | 8 Likes Like |Link to Comment
  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    I wrote a more in-depth article on my website on immuno-oncolology which requires a subscription to access. http://bit.ly/1KyuzBb

    This is written from my layman's perspective.
    Feb 6, 2015. 01:28 PM | 4 Likes Like |Link to Comment
  • Northwest Has A Differentiated Technology Platform In The Emerging Immuno-Oncology Landscape [View article]
    I am not aware that NWBO gave guidance on the exact timing of the beginning of the phase 2.
    Feb 6, 2015. 12:46 PM | 3 Likes Like |Link to Comment
  • Undervalued Celldex Offers Upside Opportunity [View article]
    I just wanted to echo that the EGFRvIII mutation only occurs in 25% or so of GBM cases.
    Jan 21, 2015. 04:50 PM | 2 Likes Like |Link to Comment
  • 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 | 3 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
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