Northwest Biotherapeutics Surges On Perfect Storm Of Short Squeeze, New Buying Interest [View article]
Nice rendition of the efficacy achievements to date for CLDX's Rindopeimut (CDX-110).
My understanding is that NWBO's DCVax-L, in their phase-1 trial, has achieved 55% OS at 3 years...uncertain if they have 4 year survival stats. Somewhere I read that 50% (8 /16) recipients of IMUC's ICT-107 reached 4 year survival from their phase-1 trial...with 3 of those achieving over 5 year survival - but another read placed the 4-yr OS at 'only' 6 of 16, so I am uncertain as to the correct figures on this; maybe Larry can clarify if he chooses to respond. It does appear that CLDX has more 'trials under the belt' so to speak, so may have an easier time with the FDA assuming positive trial results are again delivered in the current Rindopepimut trials. Though CDX-110 ACT III trial results indicating 52% OS at 2 years is impressive, one has to wonder how this will eventually stack up against the 55% 3-year OS results achieved by IMUC and NWBO, not to mention ICT-107's 4-yr survival figures.....assuming such results can be proved out in further trials.
CLDX is well funded, has sig. inst. ownership, proven technology and is further along with their pipeline than NWBO - ie., CDX-011, an antibody-drug conjugate in Phase IIb clinical trial for metastatic breast cancer and melanoma indication, among others. Of course CLDX has a MC sig. higher than the other two as well, and CDX-110 is apparently appropriate for ~ 40% of those afflicted with GBM...sig. less than the target population which DCVax-L is addressing - though one has to wonder about the difference in cost to produce/administer the different treatments.
My impression is that IMUC's ICT-107 4 and 5 year OS stats surpass all the others to date...but then again the trial was small and their treatment may only be applicable to roughly 50% of GBM patients. I wonder, assuming IMUC's current P-2 trial appears to validate the astounding efficacy results achieved in the P-1 trial, if FDA may allow them to file directly without running a P-3 trial.
Northwest Biotherapeutics Surges On Perfect Storm Of Short Squeeze, New Buying Interest [View article]
So that we are clear here....if one invests in a speculative dev. biotech and the s/p goes down instead of up - it is just soooo unfair and the company is just miserable? LOL What, are you 12 years old? Maybe SA should implement some type testing for minimal intelligence before granting posting rights.....or are you a comedian?
Promising Development-Phase Pharmas Leading The Fight Against Cancer [View article]
So assuming a burn of about $2 M per/mo....then CLSN is down to about $18 M cash reserves, or about 9 months worth as of Oct. - sounds like the $5 M left on the loan facility isn't yet available. Of course they are expecting the HEAT trial to wrap up in December I believe...but then they will be down to approx. 6 months of operating capital, and then comes the time required for trial result tabulation. I am wondering if they may not be comfortable running that low on operating capital.
Northwest And ImmunoCellular Can Both Be Big Winners With Their Cancer Vaccines [View article]
Congrats on the prescient timing Larry -
NWBO(D) share price just went vertical today, ending up almost 100% at $10.95 on only roughly 220,000 shares...apparently spiked briefly to $20 at one point! Market cap has a bit more than doubled in just a few days since the split. Guess now they can raise that $25 M at a much much nicer s/p.
Northwest And ImmunoCellular Can Both Be Big Winners With Their Cancer Vaccines [View article]
Nice article Larry -
Often cancer treatments are approved which achieve only minimal increases in overall survival, sometimes on no increase in OS but improvements in quality of life due to lessened side effect profiles - yet here we have a pretty much still under the radar treatment, in P-3 trial, potentially increasing median survival in GBM by 3 fold (though trial endpoint is PFS as you indicated) from a company with a MC under $150 M...pocket change for big pharma! I abslolutely love the fact they have wisely persued the dual tract approval approach involving both US and European trial sites - brilliant insurance against the potential of obstructionist goalpost moving tactics the FDA has become so infamous for.
Seems a bit unrealistic to speculate that the cost of treatment might be equivalent in the US, Europe and rest of world... if one even reduces your s/p target estimate by 50%, which I do, the upside is still just amazing grand slam potential.
I would be interested in the differece between cost of manufacturing DCVax-L vs IMUC's ICT-107...my guess is the tumor lysate approach cuts well into the profit margin potential. From your article it is clear that approx. 90% of GBM patients who undergo surgery will provide sufficient tumor for 3 years worth of vaccine....what about boosters for those who may live 4 and 5 years? My understanding is that from the 16 patient phase-1 trial, IMUC's vaccine has at least 6...maybe 8, (of 16) recipients who have lived for over 4 years with 3 of those achieving 5 year survival - so I had the impression that ICT-107 was in the lead as regards OS...of course there is that seeming detail which may limit IMUC's treatment to only about half the overall target population.
As regards durability/storage...is there a marked difference regarding 'shelf life' btwn the two - for instance does one or both of these treatments need to remain refrigerated following production?
*Interesting trading today immediately following the R/S....only roughly 10,000 shares traded, at least that we are privy to, with a 20% s/p appreciation! You mentioned the ' up to' $25 million capital raise upcoming....so maybe 6 million shares at $4?? Obviously the tutes weren't stampeding into Northwest today, but they sure weren't shorting it either. Considering the potential, the wise dual tract P-3 trial approach, and the inherent platform technology...astounding that BP hasn't just made them an offer already.
Thanks for shedding a bit more light on Northwest Bio....for everyone involved, investors and patients - hopefully DCVax-L turns out to be even more effective than the P-1 trials suggest.
Northwest Biotherapeutics' DCVax Cancer Vaccines Could Lead To A Sea Change In Cancer Treatment [View article]
Makes perfect sense to me - brilliant move if one has complete confidence in the likelihood of replicating stunning efficacy achieved in phase-1 trial....of course the concurrent European efforts is a very nice insurance policy when one is dealing with the FDA which allows them to more comfortably make such a jump. If you don't understand this, you don't understand the FDA reputation for absurd obstructionist, goal-post moving, treachery. Seems likely as well that NWBO will R/S at 6:1 or greater, and then dilute to raise money - waiting and watching as I expect one may be able to acquire shares at a 40 to 50 percent reduction with luck.
Taking A Flyer On This Cash-Rich Biotech With Recent Insider Buying [View article]
SQNM mngt. definately doesn't act as a group which is worried about competition - instead they act as though they expect sales to continue to beat their guidance, or they are pretty confident that another major provider is close to signing on...or both.
Dendreon's Provenge Needs To Pull Itself Together Soon [View article]
Ted, excellent response......always with such class.
Who knows what comes along in that extra avg. year of quality life, life free from the terrible ravages of chemo.....one never knows who the lucky outliers will be which live for many years after Provenge treatment. I truly believe that the onco docs are only now even beginning to realize the true potential of Provenge administered at optimum times for best true efficacy - I look forward to the synergies which will be achieved as Provenge is combined with other new treatments soon to be available.
Dendreon's Provenge Needs To Pull Itself Together Soon [View article]
MoneyHawk - Proven is not chemo.....not surprised you have made only 2 comments!
A subset of individuals, individuals with advanced unresponsive prostate cancer who have on average about 18 months to live - this subset of persons receive tremendous benefit from Provenge treatment...they have been known to recover and live for 6 or 7 years!
Imagine you have the choice of ineffective chemo which makes you so sick you likely despair of living anyway, or receiving Provenge which has only very mild transitory side effects like a mild case of the flu - and possibly living for years further.
Guys at death's door, treated with Provenge, often feel so good once it kicks in they resume playing golf! Of course Provenge given earlier in the disease process, before chemo has about destroyed the immune system, will only increase the size of that recipient subset who live additional years. Now combine Provenge with another miracle treatment and you are likely to achieve the equivalent of complete remission.....think about it, try and educate yourself a bit, then engage brain before opening mouth - it works so much better that way and people don't laugh at you then.
Trovagene: The 1 Stock That Could've Saved Steve Jobs' Life [View article]
Tsk tsk tsk James! Truly a pathetic piece you have tried to foist off on the unwary. Are you familiar with the term intellectual honesty? As for a number of current TROV mngt. types coming from SQNM....I think most would consider that an overall negative. As regards TROV.....hope they can achieve all you envision for them - but honestly you might check into an integriy exam in the mean time. Still, sans the 'problems' with your piece, I do appreciate hearing of TROV for the first time...will definately do some proper DD and hope you are correct as regards their true potential.
P.S. - why not do the 'right' thing and correct your statements regarding SQNM. The only thing holding SQNM back currently is the patent litigation cases - if they win a preliminary injunction in a couple of weeks the s/p appreciation will resume as the huge short interest is forced to cover. If they fail with the legal route, then all bets are off as the Ariosa/LabCorp test in much much cheaper.
BTW....congrats on that INHX call - that was indeed outstanding.
ImmunoCellular Therapeutics ICT-107 To Impress At ASCO 2012 [View article]
IMUC's ICT-107 indeed has achieved truly astounding efficacy results....small sample size or no, a near 4-fold 4-year survival increase over historic norms (and still counting) indicates they are onto something amazing. How IMUC languishes with a paltry market cap of roughly $130 million and has escaped BP acquisition is beyond me.
Stop-Start Realities And EV Fantasies [View article]
Hi John, thanks again for another thought provoking article.....and of course the comment give-n-take is always fun as well.
Any comments on MXWL's precipitous s/p slide since the recent earnings beat with minor downside guidance? Short interest has been slowly climbing, and recent s/p action would seem to indicate the next SI report will reflect no let-up on that front. Granted all the likely causative factors leading to a long overdue market correction at least, - still, seems from the start/stop projections you refer to that MXWL should have a bright future especially as the battery technology from AXPW doesn't appear quite ready for prime time (my assumption only for lack of that definitive first big auto contract win). I see you mentioned the pairing of the AGM battery with the MXWL supercapacitor module - yet the s/p action indicates the shorts are confident further blood can be wrung from this puppy. I am wondering if you think MXWL has begun to place on the acquisition short list of JCI or whoever? Or inversely have the shorts got wind of some major yet to be officially announced market setback looming for MXWL? Considering the recent very poor earnings report out of XIDE, I can see them being hammered into heavy oversold territory - yet they are just borderline on that front.....but look at MXWL on the RSI!
Northwest Biotherapeutics Surges On Perfect Storm Of Short Squeeze, New Buying Interest [View article]
My understanding is that NWBO's DCVax-L, in their phase-1 trial, has achieved 55% OS at 3 years...uncertain if they have 4 year survival stats. Somewhere I read that 50% (8 /16) recipients of IMUC's ICT-107 reached 4 year survival from their phase-1 trial...with 3 of those achieving over 5 year survival - but another read placed the 4-yr OS at 'only' 6 of 16, so I am uncertain as to the correct figures on this; maybe Larry can clarify if he chooses to respond. It does appear that CLDX has more 'trials under the belt' so to speak, so may have an easier time with the FDA assuming positive trial results are again delivered in the current Rindopepimut trials. Though CDX-110 ACT III trial results indicating 52% OS at 2 years is impressive, one has to wonder how this will eventually stack up against the 55% 3-year OS results achieved by IMUC and NWBO, not to mention ICT-107's 4-yr survival figures.....assuming such results can be proved out in further trials.
CLDX is well funded, has sig. inst. ownership, proven technology and is further along with their pipeline than NWBO - ie., CDX-011, an antibody-drug conjugate in Phase IIb clinical trial for metastatic breast cancer and melanoma indication, among others. Of course CLDX has a MC sig. higher than the other two as well, and CDX-110 is apparently appropriate for ~ 40% of those afflicted with GBM...sig. less than the target population which DCVax-L is addressing - though one has to wonder about the difference in cost to produce/administer the different treatments.
My impression is that IMUC's ICT-107 4 and 5 year OS stats surpass all the others to date...but then again the trial was small and their treatment may only be applicable to roughly 50% of GBM patients. I wonder, assuming IMUC's current P-2 trial appears to validate the astounding efficacy results achieved in the P-1 trial, if FDA may allow them to file directly without running a P-3 trial.
Northwest Biotherapeutics Surges On Perfect Storm Of Short Squeeze, New Buying Interest [View article]
Maybe SA should implement some type testing for minimal intelligence before granting posting rights.....or are you a comedian?
Promising Development-Phase Pharmas Leading The Fight Against Cancer [View article]
Northwest And ImmunoCellular Can Both Be Big Winners With Their Cancer Vaccines [View article]
NWBO(D) share price just went vertical today, ending up almost 100% at $10.95 on only roughly 220,000 shares...apparently spiked briefly to $20 at one point! Market cap has a bit more than doubled in just a few days since the split. Guess now they can raise that $25 M at a much much nicer s/p.
Northwest And ImmunoCellular Can Both Be Big Winners With Their Cancer Vaccines [View article]
Often cancer treatments are approved which achieve only minimal increases in overall survival, sometimes on no increase in OS but improvements in quality of life due to lessened side effect profiles - yet here we have a pretty much still under the radar treatment, in P-3 trial, potentially increasing median survival in GBM by 3 fold (though trial endpoint is PFS as you indicated) from a company with a MC under $150 M...pocket change for big pharma! I abslolutely love the fact they have wisely persued the dual tract approval approach involving both US and European trial sites - brilliant insurance against the potential of obstructionist goalpost moving tactics the FDA has become so infamous for.
Seems a bit unrealistic to speculate that the cost of treatment might be equivalent in the US, Europe and rest of world... if one even reduces your s/p target estimate by 50%, which I do, the upside is still just amazing grand slam potential.
I would be interested in the differece between cost of manufacturing DCVax-L vs IMUC's ICT-107...my guess is the tumor lysate approach cuts well into the profit margin potential. From your article it is clear that approx. 90% of GBM patients who undergo surgery will provide sufficient tumor for 3 years worth of vaccine....what about boosters for those who may live 4 and 5 years? My understanding is that from the 16 patient phase-1 trial, IMUC's vaccine has at least 6...maybe 8, (of 16) recipients who have lived for over 4 years with 3 of those achieving 5 year survival - so I had the impression that ICT-107 was in the lead as regards OS...of course there is that seeming detail which may limit IMUC's treatment to only about half the overall target population.
As regards durability/storage...is there a marked difference regarding 'shelf life' btwn the two - for instance does one or both of these treatments need to remain refrigerated following production?
*Interesting trading today immediately following the R/S....only roughly 10,000 shares traded, at least that we are privy to, with a 20% s/p appreciation! You mentioned the ' up to' $25 million capital raise upcoming....so maybe 6 million shares at $4?? Obviously the tutes weren't stampeding into Northwest today, but they sure weren't shorting it either. Considering the potential, the wise dual tract P-3 trial approach, and the inherent platform technology...astounding that BP hasn't just made them an offer already.
Thanks for shedding a bit more light on Northwest Bio....for everyone involved, investors and patients - hopefully DCVax-L turns out to be even more effective than the P-1 trials suggest.
ICT-107 Into Perspective: Part 2 [View article]
Looking forward to the updated article/interview when it is cleared for publication and any insights you have regarding NWBO as well.
Northwest Biotherapeutics' DCVax Cancer Vaccines Could Lead To A Sea Change In Cancer Treatment [View article]
Taking A Flyer On This Cash-Rich Biotech With Recent Insider Buying [View article]
A123 Systems: An Object Lesson In Toxic Financing [View article]
Dendreon's Provenge Needs To Pull Itself Together Soon [View article]
Who knows what comes along in that extra avg. year of quality life, life free from the terrible ravages of chemo.....one never knows who the lucky outliers will be which live for many years after Provenge treatment. I truly believe that the onco docs are only now even beginning to realize the true potential of Provenge administered at optimum times for best true efficacy - I look forward to the synergies which will be achieved as Provenge is combined with other new treatments soon to be available.
Dendreon's Provenge Needs To Pull Itself Together Soon [View article]
Proven is not chemo.....not surprised you have made only 2 comments!
A subset of individuals, individuals with advanced unresponsive prostate cancer who have on average about 18 months to live - this subset of persons receive tremendous benefit from Provenge treatment...they have been known to recover and live for 6 or 7 years!
Imagine you have the choice of ineffective chemo which makes you so sick you likely despair of living anyway, or receiving Provenge which has only very mild transitory side effects like a mild case of the flu - and possibly living for years further.
Guys at death's door, treated with Provenge, often feel so good once it kicks in they resume playing golf! Of course Provenge given earlier in the disease process, before chemo has about destroyed the immune system, will only increase the size of that recipient subset who live additional years. Now combine Provenge with another miracle treatment and you are likely to achieve the equivalent of complete remission.....think about it, try and educate yourself a bit, then engage brain before opening mouth - it works so much better that way and people don't laugh at you then.
A New Look At Galena's NeuVax While Lowering Analyst's Raised Red Flags [View article]
Trovagene: The 1 Stock That Could've Saved Steve Jobs' Life [View article]
P.S. - why not do the 'right' thing and correct your statements regarding SQNM. The only thing holding SQNM back currently is the patent litigation cases - if they win a preliminary injunction in a couple of weeks the s/p appreciation will resume as the huge short interest is forced to cover. If they fail with the legal route, then all bets are off as the Ariosa/LabCorp test in much much cheaper.
BTW....congrats on that INHX call - that was indeed outstanding.
ImmunoCellular Therapeutics ICT-107 To Impress At ASCO 2012 [View article]
Stop-Start Realities And EV Fantasies [View article]
Any comments on MXWL's precipitous s/p slide since the recent earnings beat with minor downside guidance? Short interest has been slowly climbing, and recent s/p action would seem to indicate the next SI report will reflect no let-up on that front. Granted all the likely causative factors leading to a long overdue market correction at least, - still, seems from the start/stop projections you refer to that MXWL should have a bright future especially as the battery technology from AXPW doesn't appear quite ready for prime time (my assumption only for lack of that definitive first big auto contract win). I see you mentioned the pairing of the AGM battery with the MXWL supercapacitor module - yet the s/p action indicates the shorts are confident further blood can be wrung from this puppy. I am wondering if you think MXWL has begun to place on the acquisition short list of JCI or whoever? Or inversely have the shorts got wind of some major yet to be officially announced market setback looming for MXWL? Considering the recent very poor earnings report out of XIDE, I can see them being hammered into heavy oversold territory - yet they are just borderline on that front.....but look at MXWL on the RSI!
Best2U always