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they are necessary aren't they...hog
$TROV...Cantor Reiterates Buy on TrovaGene Inc Following Data Presentations
March 16, 2015 12:59 PM EDT by Jason Cohen, Editor in Healthcare • Insights
In a research report issued today, Cantor analyst Sung Ji Nam reiterated a Buy rating on TrovaGene Inc (NASDAQ:TROV) with an $8 price target, after several presentations at major medical conferences.
Nam noted, “TROV has underway clinical studies with 15 leading cancer treatment centers around the world (>2,500 patients in aggregate) involving its liquid biopsy platform (PCM). TROV’s initial target cancer areas are lung, colorectal, pancreatic, and melanoma. For example, TROV has underway four clinical studies for lung cancer, and expects to enroll over 500 patients in aggregate. TROV expects to present and publish results from these studies throughout this year to drive early adoption for PCM starting in 2H.”
http://www.smarteranalyst.com/2015/03/16/cantor-reiterates-buy-trovagene-inc-following-data-presentations/
$STWS...nice looking chart conix....good volume today...hog
Citrati...thank you sir...pretty much what i was thinking...looking for a bottom but guess i need to wait a little longer...i hope your portfolio is looking better than mine right now...lots of red numbers on my screen...hog
no kidding...i erased my rampage...just say that people dont have a clue what she is going thru....hog
Neuralstem: Initial Take on Top Line Results of Phase 2 ALS Trial of NSI-566 Neural Stem Cells (CUR, Buy, $3.08)
POSTED by LARRY SMITH on MAR 12, 2015 • (0)
The topline data for the phase 2 trial of NSI-566 stem cells were released today. The initial stock reaction indicates that some investors were disappointed with the results as the stock sold off sharply at the opening. However, I view the results as encouraging and believe that if they are replicated in an upcoming phase 2/3 trial, that NSI-566 neural stem cells have a high probability for approval in treating ALS. My buy recommendation on the stock continues. I will write more on the results in this phase 2 trial as the data becomes available. Neuralstem will present at the Barclay’s conference today (March 12) at 2:35 PM EDT and could provide more information. The press release stated:
The study met primary safety endpoints. The maximum tolerated dose of 16 million transplanted cells and the surgery was well tolerated.
Secondary efficacy endpoints at nine months post-surgery indicate a 47% response rate to the stem cell treatment, as measured by either near-zero slope of decline or positive slope of ALSFRS score in seven out of 15 patients and by either a near-zero decline, or positive strengthening, of grip strength in seven out of 15 patients.
The average ALSFRS score for responders at 9 months after treatment was 37. Non-responders scored an average of 14. These scores represent 93%, versus 35%, of the baseline score retained, respectively, by the responders versus non-responders at 9 months, which is a statistically significant difference.
As measured by an average slope of decline of ALSFRS, responders’ disease progression was -0.007 point per day, while non-responders’ disease progression was -0.1 per day, which was again statistically significant.
Lung function as measured by Seated Vital Capacity shows that responder patients remained within 94% of their starting scores, versus 71% for non-responder patients.
The trial met its primary safety endpoints. Both the surgery and cells were well-tolerated, with one patient experiencing a surgical serious adverse event. In this study, cervical intervention was both safe and well-tolerated with up to 8 million cells in 20 bilateral injections
I will give my first impression of the data. However, I find that it takes time and thought to come to a final conclusion and there is much more to try to understand. There appears to be a sub-set of patients who respond very positively to NSI-566 neural stem cell transplants. In the previous phase 1 trial, five patients had an impressive response out of 12 treated. However, some of the early patients treated in the trial were end stage ALS patients who had little hope of recovery and volunteered for the trial to help determine that the surgery and cells were safe so that they could be implanted in healthier patients who might benefit, like Ted Harrada. There were other patients with bulbar onset disease who don’t appear to respond to the NSI-566 cells.
The response rate in the first phase 1 trial is indeterminate. We know that the numerator is five, but we don’t know the denominator. The minimal possible response rate in phase 1 was 42%. Now, the response rate in the second trial is 7 of 15 or 47%. These two trials seem to establish that the NSI-566 neural stem cells are very effective in a sub-group that may be about 50% of ALS patients.
There was no information on results on the five individual dosing cohorts of the phase 2 study in the press release, but I am sure we will learn more on this. One of the keys going forward will be whether this sub-group of responders can be prospectively defined. The Company said “We believe these types of endpoints, measuring muscle strength, will allow us to effectively predict patients that will respond to treatment, adding a sensitive measure of the therapeutic effects after treatment. Testing this hypothesis will be one of the primary goals of our next trial.”
So how good are the results? I think that the thinking on NSI-566 has been overly influenced by the well-publicized, remarkable results experienced by Ted Harrada. This may have caused expectations to be at too high levels. The initial reaction of investors seems to be that the results were alright but perhaps a little disappointing. However, I view these results as encouraging and think this initial reaction is incorrect. There have been no successful trials in ALS to compare these results to. In my mind, I try to compare these results to late stage cancer patients who like ALS patients are in a desperate life threatening condition and usually have no treatment options.
In late stage cancer patients an overall response rate of 47% that is durable over a nine month period as seen with this phase 2 ALS trial would be extremely positive. The checkpoint modulators, Opdivo and Keytruda, are showing durable responses of about 30% in patients with late stage melanoma or lung cancer. These drugs are being hailed as breakthroughs in these diseases. I think that we can view NSI-566 neural stem cells in the same light in regard to ALS. This looks like a breakthrough.
In the 47% of patients who responded to treatment we are seeing durable responses over nine months. One of the key things to look for is whether these responses will be maintained over three years or so as was seen with Ted Harrada and two other patients from the phase 1 trial. Nine months of duration of effect is impressive but two years or more would be outstanding.
The disease states of responders have roughly stabilized over nine months. Let me put this in perspective by looking at the ALSFRS-r score. On this score, a perfectly normal patient would score 48. Most patients are diagnosed with ALSFRS-r scores in the high 30s or low 40S. Deaths, usually from respiratory issues, begin to occur in the 10 to 20 range. The responders had an ALSFRS-r score of 37 at nine months while non-responders averaged 14. This is a remarkable result.
The seated vital capacity (SVC) score also seemed to indicate that respiratory function was significantly improved in the responders relative to the non-responders. I need to do more work on the interpretation of these results.
I think that the next trial of NSI-566 could begin in coming months. If these phase 2 results are replicated, I think that it could be the basis for approval. One of the key issues in the potential commercialization of NSI-566 in ALS will be the ability to prospectively define who will benefit. This is a complicated surgery. I think that many or most patients faced with a 50/50 chance of the surgery being able to prolong their life by at least the nine months seen so far, would opt to go ahead. However, it could be a deterrent for some.
$CUR...Neuralstem: Initial Take on Top Line Results of Phase 2 ALS Trial of NSI-566 Neural Stem Cells (CUR, Buy, $3.08)
POSTED by LARRY SMITH on MAR 12, 2015 • (0)
The topline data for the phase 2 trial of NSI-566 stem cells were released today. The initial stock reaction indicates that some investors were disappointed with the results as the stock sold off sharply at the opening. However, I view the results as encouraging and believe that if they are replicated in an upcoming phase 2/3 trial, that NSI-566 neural stem cells have a high probability for approval in treating ALS. My buy recommendation on the stock continues. I will write more on the results in this phase 2 trial as the data becomes available. Neuralstem will present at the Barclay’s conference today (March 12) at 2:35 PM EDT and could provide more information. The press release stated:
The study met primary safety endpoints. The maximum tolerated dose of 16 million transplanted cells and the surgery was well tolerated.
Secondary efficacy endpoints at nine months post-surgery indicate a 47% response rate to the stem cell treatment, as measured by either near-zero slope of decline or positive slope of ALSFRS score in seven out of 15 patients and by either a near-zero decline, or positive strengthening, of grip strength in seven out of 15 patients.
The average ALSFRS score for responders at 9 months after treatment was 37. Non-responders scored an average of 14. These scores represent 93%, versus 35%, of the baseline score retained, respectively, by the responders versus non-responders at 9 months, which is a statistically significant difference.
As measured by an average slope of decline of ALSFRS, responders’ disease progression was -0.007 point per day, while non-responders’ disease progression was -0.1 per day, which was again statistically significant.
Lung function as measured by Seated Vital Capacity shows that responder patients remained within 94% of their starting scores, versus 71% for non-responder patients.
The trial met its primary safety endpoints. Both the surgery and cells were well-tolerated, with one patient experiencing a surgical serious adverse event. In this study, cervical intervention was both safe and well-tolerated with up to 8 million cells in 20 bilateral injections
I will give my first impression of the data. However, I find that it takes time and thought to come to a final conclusion and there is much more to try to understand. There appears to be a sub-set of patients who respond very positively to NSI-566 neural stem cell transplants. In the previous phase 1 trial, five patients had an impressive response out of 12 treated. However, some of the early patients treated in the trial were end stage ALS patients who had little hope of recovery and volunteered for the trial to help determine that the surgery and cells were safe so that they could be implanted in healthier patients who might benefit, like Ted Harrada. There were other patients with bulbar onset disease who don’t appear to respond to the NSI-566 cells.
The response rate in the first phase 1 trial is indeterminate. We know that the numerator is five, but we don’t know the denominator. The minimal possible response rate in phase 1 was 42%. Now, the response rate in the second trial is 7 of 15 or 47%. These two trials seem to establish that the NSI-566 neural stem cells are very effective in a sub-group that may be about 50% of ALS patients.
There was no information on results on the five individual dosing cohorts of the phase 2 study in the press release, but I am sure we will learn more on this. One of the keys going forward will be whether this sub-group of responders can be prospectively defined. The Company said “We believe these types of endpoints, measuring muscle strength, will allow us to effectively predict patients that will respond to treatment, adding a sensitive measure of the therapeutic effects after treatment. Testing this hypothesis will be one of the primary goals of our next trial.”
So how good are the results? I think that the thinking on NSI-566 has been overly influenced by the well-publicized, remarkable results experienced by Ted Harrada. This may have caused expectations to be at too high levels. The initial reaction of investors seems to be that the results were alright but perhaps a little disappointing. However, I view these results as encouraging and think this initial reaction is incorrect. There have been no successful trials in ALS to compare these results to. In my mind, I try to compare these results to late stage cancer patients who like ALS patients are in a desperate life threatening condition and usually have no treatment options.
In late stage cancer patients an overall response rate of 47% that is durable over a nine month period as seen with this phase 2 ALS trial would be extremely positive. The checkpoint modulators, Opdivo and Keytruda, are showing durable responses of about 30% in patients with late stage melanoma or lung cancer. These drugs are being hailed as breakthroughs in these diseases. I think that we can view NSI-566 neural stem cells in the same light in regard to ALS. This looks like a breakthrough.
In the 47% of patients who responded to treatment we are seeing durable responses over nine months. One of the key things to look for is whether these responses will be maintained over three years or so as was seen with Ted Harrada and two other patients from the phase 1 trial. Nine months of duration of effect is impressive but two years or more would be outstanding.
The disease states of responders have roughly stabilized over nine months. Let me put this in perspective by looking at the ALSFRS-r score. On this score, a perfectly normal patient would score 48. Most patients are diagnosed with ALSFRS-r scores in the high 30s or low 40S. Deaths, usually from respiratory issues, begin to occur in the 10 to 20 range. The responders had an ALSFRS-r score of 37 at nine months while non-responders averaged 14. This is a remarkable result.
The seated vital capacity (SVC) score also seemed to indicate that respiratory function was significantly improved in the responders relative to the non-responders. I need to do more work on the interpretation of these results.
I think that the next trial of NSI-566 could begin in coming months. If these phase 2 results are replicated, I think that it could be the basis for approval. One of the key issues in the potential commercialization of NSI-566 in ALS will be the ability to prospectively define who will benefit. This is a complicated surgery. I think that many or most patients faced with a 50/50 chance of the surgery being able to prolong their life by at least the nine months seen so far, would opt to go ahead. However, it could be a deterrent for some.
http://smithonstocks.com/neuralstem-initial-take-on-top-line-results-of-phase-2-als-trial-of-nsi-566-neural-stem-cells-cur-buy-3-08/
Nice PT of 33....
$DSCO AEROSURF, the Company's novel investigational drug-device combination product being developed to deliver aerosolized KL4 surfactant to premature infants with respiratory distress syndrome (RDS), addresses a significant unmet medical need. The phase 2 clinical program consists of an ongoing phase 2a trial designed to assess safety and tolerability of aerosolized KL4 surfactant delivered through continuous positive airway pressure (nCPAP), and a planned phase 2b trial intended to determine the optimal dose and define the expected efficacy margin for a phase 3 clinical program. Based upon the Company's most recent assessment of the clinical trial plan, the Company now anticipates phase 2a data in the first quarter of 2015.
chart...
$NBS...We also are planning the release of one-year data from the PreSERVE Phase 2 trial for acute myocardial infarction on March 15, 2015 at the Annual Scientific Sessions of the American College of Cardiology. We expect that these results will further corroborate the results observed at 6 months of a clinically meaningful effect of our NBS10 candidate.” - See more at: http://www.neostem.com/media/press-releases/news-item/neostem-inc-announces-2014-year-end-financial-results-and-provides-corporate-update/#sthash.ThmQnHZN.dpuf
CHART
you are kicking butt with S*N...i fumbled there...hog
Bowel and Bladder control is a huge win for these pts and NVIV going forward...the costs involved are tremendous if a pt doesnt have control of b & b...
NVIV...InVivo Therapeutics Reports 2014 Year End Financial Results and Business Update
InVivo Therapeutics Holdings (USOTC:NVIV)
Intraday Stock Chart
Today : Wednesday 11 March 2015
InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2014.
Mark Perrin, InVivo’s CEO and Chairman, said, “2014 was a momentous year for InVivo in every sense of the word. It’s gratifying to look back on how much we accomplished last year and exciting to see the trajectory the company is following. We are in a much better position to execute on our corporate goals than we were only 15 months ago and are significantly closer to achieving our mission: to redefine the life of the spinal cord injury patient. I’m pleased with how we’ve advanced as a company and am very much looking forward to a fruitful 2015.”
Business Highlights
Hired experienced leadership team
InVivo’s five corporate officers, all new to the company since January 2014, bring significant depth and breadth regarding the development, approval, and commercialization of products. As a cohesive unit, the company is on a path poised for success.
Initiated pilot trial with Neuro-Spinal Scaffold
In 2014, the first-ever implantation of the company’s Neuro-Spinal Scaffold took place. In the months that followed, an appreciable improvement in the first subject’s motor and sensory function was reported (improved from AIS A to C) as well as complete recovery of bowel function and improvement in bladder function. The second-ever implantation of the Neuro-Spinal Scaffold was done in January 2015.
Accelerated pilot trial timeline with FDA
In December 2014, InVivo was able to expedite the original subject enrollment plan by eliminating mandatory holds between enrollment of the final three subjects, thereby reducing the clinical timeline. Barring any significant safety issues, concurrent enrollment of subjects three through five is anticipated to open by the end of March 2015.
Raised cash to fund trial and operations
In May 2014, InVivo successfully raised approximately $16.1 million to fund the ongoing pilot trial and operations. The company also recently closed an additional round of financing, led by our largest shareholder, and received gross proceeds of $12 million. InVivo believes it is in a strong cash position to further advance the company’s mission.
Realigned and focused R&D efforts and reduced burn
The company is solely focused on developing therapies for spinal cord injury patients. By reducing headcount, streamlining processes, and subsequently realigning and focusing internal efforts, InVivo is on a great path to success.
Financial Results
For the year ended December 31, 2014, the company reported a net loss of approximately $18,346,000, or $0.21 per diluted share, compared to a loss of $38,756,000, or $0.52 per diluted share, for the year ending December 31, 2013. Included in results for the years ended December 31, 2014 and 2013 were non-cash losses of $376,000 and $18,871,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the derivative warrant liability, non-cash losses associated with modification of warrants in 2013 and restructuring costs incurred in the second quarter of 2014, adjusted net loss for the year ending December 31, 2014, was $17,970,000, or $0.20 per diluted share, compared to an adjusted net loss of $19,120,000, or $0.26 per diluted share, for 2013. The company ended the year with $13,459,000 of cash and cash equivalents.
Adjusted net loss and adjusted net loss per diluted share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the company’s operations on a period-to-period comparable basis after taking into account the impact of the identified items.
InVivo Therapeutics Reports 2014 Year End Financial Results and Business Update
Print
Alert
InVivo Therapeutics Holdings (USOTC:NVIV)
Intraday Stock Chart
Today : Wednesday 11 March 2015
Click Here for more InVivo Therapeutics Holdings Charts.
InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2014.
Mark Perrin, InVivo’s CEO and Chairman, said, “2014 was a momentous year for InVivo in every sense of the word. It’s gratifying to look back on how much we accomplished last year and exciting to see the trajectory the company is following. We are in a much better position to execute on our corporate goals than we were only 15 months ago and are significantly closer to achieving our mission: to redefine the life of the spinal cord injury patient. I’m pleased with how we’ve advanced as a company and am very much looking forward to a fruitful 2015.”
Business Highlights
Hired experienced leadership team
InVivo’s five corporate officers, all new to the company since January 2014, bring significant depth and breadth regarding the development, approval, and commercialization of products. As a cohesive unit, the company is on a path poised for success.
Initiated pilot trial with Neuro-Spinal Scaffold
In 2014, the first-ever implantation of the company’s Neuro-Spinal Scaffold took place. In the months that followed, an appreciable improvement in the first subject’s motor and sensory function was reported (improved from AIS A to C) as well as complete recovery of bowel function and improvement in bladder function. The second-ever implantation of the Neuro-Spinal Scaffold was done in January 2015.
Accelerated pilot trial timeline with FDA
In December 2014, InVivo was able to expedite the original subject enrollment plan by eliminating mandatory holds between enrollment of the final three subjects, thereby reducing the clinical timeline. Barring any significant safety issues, concurrent enrollment of subjects three through five is anticipated to open by the end of March 2015.
Raised cash to fund trial and operations
In May 2014, InVivo successfully raised approximately $16.1 million to fund the ongoing pilot trial and operations. The company also recently closed an additional round of financing, led by our largest shareholder, and received gross proceeds of $12 million. InVivo believes it is in a strong cash position to further advance the company’s mission.
Realigned and focused R&D efforts and reduced burn
The company is solely focused on developing therapies for spinal cord injury patients. By reducing headcount, streamlining processes, and subsequently realigning and focusing internal efforts, InVivo is on a great path to success.
Financial Results
For the year ended December 31, 2014, the company reported a net loss of approximately $18,346,000, or $0.21 per diluted share, compared to a loss of $38,756,000, or $0.52 per diluted share, for the year ending December 31, 2013. Included in results for the years ended December 31, 2014 and 2013 were non-cash losses of $376,000 and $18,871,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the derivative warrant liability, non-cash losses associated with modification of warrants in 2013 and restructuring costs incurred in the second quarter of 2014, adjusted net loss for the year ending December 31, 2014, was $17,970,000, or $0.20 per diluted share, compared to an adjusted net loss of $19,120,000, or $0.26 per diluted share, for 2013. The company ended the year with $13,459,000 of cash and cash equivalents.
Adjusted net loss and adjusted net loss per diluted share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the company’s operations on a period-to-period comparable basis after taking into account the impact of the identified items.
$NVIV...InVivo Therapeutics Reports 2014 Year End Financial Results and Business Update
Print
Alert
InVivo Therapeutics Holdings (USOTC:NVIV)
Intraday Stock Chart
Today : Wednesday 11 March 2015
Click Here for more InVivo Therapeutics Holdings Charts.
InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2014.
Mark Perrin, InVivo’s CEO and Chairman, said, “2014 was a momentous year for InVivo in every sense of the word. It’s gratifying to look back on how much we accomplished last year and exciting to see the trajectory the company is following. We are in a much better position to execute on our corporate goals than we were only 15 months ago and are significantly closer to achieving our mission: to redefine the life of the spinal cord injury patient. I’m pleased with how we’ve advanced as a company and am very much looking forward to a fruitful 2015.”
Business Highlights
Hired experienced leadership team
InVivo’s five corporate officers, all new to the company since January 2014, bring significant depth and breadth regarding the development, approval, and commercialization of products. As a cohesive unit, the company is on a path poised for success.
Initiated pilot trial with Neuro-Spinal Scaffold
In 2014, the first-ever implantation of the company’s Neuro-Spinal Scaffold took place. In the months that followed, an appreciable improvement in the first subject’s motor and sensory function was reported (improved from AIS A to C) as well as complete recovery of bowel function and improvement in bladder function. The second-ever implantation of the Neuro-Spinal Scaffold was done in January 2015.
Accelerated pilot trial timeline with FDA
In December 2014, InVivo was able to expedite the original subject enrollment plan by eliminating mandatory holds between enrollment of the final three subjects, thereby reducing the clinical timeline. Barring any significant safety issues, concurrent enrollment of subjects three through five is anticipated to open by the end of March 2015.
Raised cash to fund trial and operations
In May 2014, InVivo successfully raised approximately $16.1 million to fund the ongoing pilot trial and operations. The company also recently closed an additional round of financing, led by our largest shareholder, and received gross proceeds of $12 million. InVivo believes it is in a strong cash position to further advance the company’s mission.
Realigned and focused R&D efforts and reduced burn
The company is solely focused on developing therapies for spinal cord injury patients. By reducing headcount, streamlining processes, and subsequently realigning and focusing internal efforts, InVivo is on a great path to success.
Financial Results
For the year ended December 31, 2014, the company reported a net loss of approximately $18,346,000, or $0.21 per diluted share, compared to a loss of $38,756,000, or $0.52 per diluted share, for the year ending December 31, 2013. Included in results for the years ended December 31, 2014 and 2013 were non-cash losses of $376,000 and $18,871,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the derivative warrant liability, non-cash losses associated with modification of warrants in 2013 and restructuring costs incurred in the second quarter of 2014, adjusted net loss for the year ending December 31, 2014, was $17,970,000, or $0.20 per diluted share, compared to an adjusted net loss of $19,120,000, or $0.26 per diluted share, for 2013. The company ended the year with $13,459,000 of cash and cash equivalents.
Adjusted net loss and adjusted net loss per diluted share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the company’s operations on a period-to-period comparable basis after taking into account the impact of the identified items.
http://ih.advfn.com/p.php?pid=nmona&article=65815962&symbol=NVIV
now if i had bought with you then they would probably have declared bankruptcy today...lol...hog
$CYNAF...Cynapsus Therapeutics Inc. today announced that it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding Cynapsus’ APL-130277 drug candidate for the acute...
Cynapsus plans to initiate a pivotal Ph3 program evaluating the safety and efficacy of APL-130277 in PD patients in the Q215
agreement was reached on the design, duration and size for the Phase 3 studies, as well as for primary and key secondary endpoints...
CTH-105 final data is impressive insofar as to re-confirm no tox, no dropouts and eff. & rapid sublingual uptake.
http://finance.yahoo.com/news/cynapsus-therapeutics-provides-clinical-regulatory-201000515.html
lol..Cynapsus Therapeutics Provides Clinical and Regulatory Update for...
Cynapsus Therapeutics Inc. today announced that it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding Cynapsus’ APL-130277 drug candidate for the acute...
agreement was reached on the design, duration and size for the Phase 3 studies, as well as for primary and key secondary endpoints
$CYNAF Cynapsus plans to initiate a pivotal Ph3 program evaluating the safety and efficacy of APL-130277 in PD patients in the Q215
.http://finance.yahoo.com/news/cynapsus-therapeutics-provides-clinical-regulatory-201000515.html
$NVIV...pt #1 latest update...click show all updates...this studys endpoint is safety...http://www.gofundme.com/fytic4
$CYNAF announces it has completed an End-of-Phase 2 meeting with the FDA regarding Cynapsus’ APL-130277 drug http://finance.yahoo.com/news/cynapsus-therapeutics-provides-clinical-regulatory-201000515.html …
from twitter...Raj R ?@rajramaswamy 3m3 minutes ago
$CYNAF - per PR today, great to see co lining up the ducks in row (all study results) and starting P3 in 2q15. Execution at its best
Psionic...my best friend / gf bought MEIP today on my encouragement and if i didnt advise her she wouldnt be in NVIV, CUR, TGTX and she bought SYN when i got left in the dust...hell telling her may be the wrong choice of words...she's a country girl from south arkansas...lol...hog
i know...i was just laughing at the timing...i had been telling my friend to look at what you were holding and she picked that one...a small position...all good...just have to ride longer...hog
$IMNP...dontcha hate when you buy and $heff sells...even worse when you tell you giflfriend to buy and the same day $heff posts he sold...lol...hog
http://investorshub.advfn.com/$heffs-$tation-of-$tocks-&-$olid-DD-9413/ and on twitter...125k followers there..he's a good guy...ive made some good money following his plays...hog
$TROV...Trovagene Schedules Release of Fourth Quarter and Year End 2014 Financial Results and Investor Conference Call
Feb 26, 2015
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SAN DIEGO, Feb. 26, 2015 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that it will report financial results for the fourth quarter and the twelve months ended December 31, 2014 on Thursday, March 12, 2015 at 4:00 p.m. Eastern Daylight Time (1:00 p.m. Pacific Daylight Time).
A molecular diagnostics company with unique intellectual property around the discovery that DNA and RNA, present in urine, can be diagnostic of cancer and infectious disease.
Trovagene's senior management team will host a conference call on Thursday, March 12, 2015 at 5:00 p.m. Eastern Daylight Time (2:00 p.m. Pacific Daylight Time) to discuss the results and update investors on the Company's progress.
A live webcast of the call will be available online at www.trovagene.investorroom.com. To access the conference call, please dial (888) 347-6081 (domestic), (412) 902-4285 (international), or (855) 669-9657 (Canada), conference ID# 10061230. To access the telephone replay of the call, dial (877) 344-7529 (domestic), (412) 317-0088 (international), or (855) 669-9658 (Canada), replay ID# 10061230. The replay will be available one hour after the conclusion of the call. The webcast and telephone replay will be archived on the Company's website following the conference.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company's technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene's precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.
Contact
Investor Relations
Media Relations
David Moskowitz and Amy Caterina
Investor Relations
Ian Stone
Account Director
Trovagene, Inc.
Canale Communications, Inc.
858-952-7593
619-849-5388
ir@trovagene.com
ian@canalecomm.com
Logo - http://photos.prnewswire.com/prnh/20120620/LA28014LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/trovagene-schedules-release-of-fourth-quarter-and-year-end-2014-financial-results-and-investor-conference-call-300042381.html
SOURCE Trovagene, Inc.
$TROV...financials, 3/12...from Yahoo message board....
mgm2020 • Mar 9, 2015 3:18 PM Flag
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I just got off the phone with Amy Katerina at TROV IR---discussed many points with her....
First thing she told me was that TROV will be speaking at 3 key conferences in the next 8 weeks. The European Lung Conference is taking place in April and TROV will be there to speak about their lung cancer detection test. 2 of the bigger conferences this year are in May---AACR and ASCO, and TROV will be at both. When I pressed her about commercialization, what she said was that the tests ARE available right now, but when I asked her about insurance panel coverage and reimbursement she said that the tests are not similar to drugs, where the drug becomes approved and then the company goes panel to panel to be placed on formularies. The insurance companies begin covering the tests initially on a patient by patient basis, and some are covering the tests while some are not. But they do have a sales and marketing team in place that will be very active in the second half of the year. I asked her to give me a percentage of confidence that the BRAF and KRAS tests will be available and rolled out this year and she said she "had no reason to believe that by the end of 2015 the BRAF and KRAS tests will be commercialized". She also said that they are working with Medicare Part D to get the tests covered, but the problem is, that there is no exact code for the type of test that TROV has using urine as the test sample and measuring cancer load and mutational status. I brought up EXAS and BIOC, and she was aware of both, saying that EXAS has only one test, and bioc also uses a blood sample, but she stated that she thought the TROV tests provide much superior results. I will continue this in my next post. Less
Sentiment: Strong Buy
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pgsjackson • Mar 9, 2015 4:37 PM
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Great post. I am assuming, from your optimism, that when you said, she "had no reason to believe that by the end of 2015 the BRAF and KRAS tests will be commercialized" it was a typo. Just making sure you meant to say that she HAD reason to believe they will be commercialized...
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mgm2020 • Mar 9, 2015 6:13 PM
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Can't believe I missed that. Yes, she said she had no reason to believe that by the end of 2015 the tests would NOT be commercialized. So---I took that to mean she had 100% confidence at this time.
Sentiment: Strong Buy
mgm2020 • Mar 9, 2015 3:24 PM Flag
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I asked her about the HPV test that they have developed and she said that they are looking to "partner" on that globally. I do not know exactly what that means, but I like it. They are compiling more trial data, and the data that comes out this time will be on a much larger scale----in the hundreds of tests, and it will not be a prospective or retrospective study, but a blinded trial to verify precision and accuracy. It looks like the second half of the year is when everything should be taking place and she sounded very confident that the tests would be ramped up and commercialized AND covered by insurance by the end of this year. I see the upcoming "earnings" announcement as a non-even and basically clarification of what to expect for the remainder of this year. I also brought up the secondary and the 23% discount on the stock price and she basically said "that's what the market would bear" and the underwriters. But she said that the recovery in the stock price is encouraging also. That's all I have. Give her a call. She is willing to answer all of your questions. Less
Sentiment: Strong Buy
$TGTX...TG Therapeutics, Inc. to Host Conference Call on Fourth Quarter and Year-End 2014 Financial Results and Business Update
Date : 03/10/2015 @ 8:30AM
Source : GlobeNewswire Inc.
Stock : TG Therapeutics, Inc. (MM) (TGTX)
Quote : 16.02 0.4 (2.56%) @ 5:20PM
TG Therapeutics, Inc. to Host Conference Call on Fourth Quarter and Year-End 2014 Financial Results and Business Update
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TG Therapeutics, Inc. (MM) (NASDAQ:TGTX)
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Today : Tuesday 10 March 2015
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TG Therapeutics, Inc. (Nasdaq:TGTX), today announced that a conference call will be held on Thursday, March 12, 2015 at 8:30am ET to discuss results for the fourth quarter and year-end 2014, and provide a business outlook for 2015. Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer, will host the call.
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Year-End 2014 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The Company also has a pre-clinical program to develop IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.
TGTX - G
CONTACT: Jenna Bosco
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: jb@tgtxinc.com
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514... what catalyst would that be??? financials??? hog
Hound...i thought you were nuts for selling at 3.05....nice call...hog
The scaffold has proven safety...who wouldnt want it if injured and i would be begging for stem cells to boot...stinks the pps is where it is but i look at it as a gift...the study isnt even 40% complete with so many catalysts to come...3 more pts will be announced and updates to follow...they should have plenty of money going forward so really shouldnt be any surprises...all my opinion of course...hog
i have added...hog
snort snort...thank you sir...hog