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i'm on the same boat..perhaps i loaded to soon but am not concerned because the mkt cap vs what the potential value are not in line just like my $clsn investment
their cash runway is till q4 2012
source: http://bit.ly/yNewNH
weakness could just be a lack of catalysts & probable need for a raise to extend that runway into 2013
1:5 reverse split
1) The Doxorubicin binds to the DNA of the tumor when released inside the tumor.
2) I dont believe that is an issue (i have read countless research information and not 1 mention about that) ... not saying its a bad question but its totally above my head
3) I havent researched into DCTH so I can't answer in specific
4) Cant answer that with any level of certainty, but its defiantly going to be a higher mkt cap then where it is right now
sorry to late reply and for some of the vague answers but unless there's research data out there for it, i cant give you exact answers.
thanks
$NEOP related. You can read and decide for yourself whether or not Neoprobe chose the correct comparator for their NEO3-05 and NEO3-09 trials.
COMPARATORS
IX. Select comparator(s) from among commonly used FDA-approved drugs for the targeted new indication that decision makers deem to have the greatest clinical net benefit
Rationale. There are relatively few instances in which only a placebo comparison would be acceptable
for trials of FDA-approved drugs being examined outside currently labeled indications. Instead, trials
should utilize active comparators that are FDA approved and commonly used for the targeted indication. If there are multiple comparators that meet these criteria, the comparator should be the FDA-approved agent with the greatest clinical net benefit for the targeted indication; clinical net benefit reflects both survival and HRQoL benefits as well as safety concerns. While a placebo arm may be required by the FDA in certain circumstances, it frequently will be unnecessary when an active comparator trial is designed to demonstrate superiority or non-inferiority in a post-approval trial.
Implementation.
- Comparators should be commonly used for the targeted indication, but the best comparator is not
necessarily the market leader in terms of sales. Market size may reflect marketing practices of
pharmaceutical manufacturers and/or rebates and discounts rather than the most favorable
benefit-to-risk profile. Comparators with low net benefit profiles should be avoided because
demonstrating superiority to such a comparator would not provide meaningful evidence of net
benefit. Also, comparators with infrequent use are less informative for prescriber and payer
decision-making since the trial results will not answer relevant questions about the comparative
effectiveness of more commonly used drugs. The final selection of comparators should be informed
by discussions with decision makers. Trial designers should bring together a panel of prescribers,
payers, and informed consumers or patients/patient advocates to assist with the process of
selecting a comparator.
- Comparisons to “current best care” should only be used when this type of standard of care reflects
evidence-based clinical practice in the community. When a recently updated national consensusbased clinical guideline exists, the comparator treatment arm should reflect that guidance, not
merely expert opinion or routine care. Analysis of up-to-date administrative claims data sets can be
used to verify “standard of care.
- Placebo comparisons may be acceptable when there are no approved therapies for the targeted
indication in the targeted line of therapy. Typically, the “placebo” comparator should be Best
Supportive Care.
$CLSN – My brief Celsion Corporation DD
Friday's open $3.18
Friday's close $3.13
52-week high $3.87
52-week low $1.98
Market capitalization 61.5M
Avg. volume (10-day) 448.0K
Shares outstanding 19.6M
In my opinion, the investment of Celsion at this price with this market capitalization is an absolute steal. Currently, the company is conducting a pivotal Phase III clinical trial for primary liver cancer and a Phase II study for recurrent chest wall breast cancer.
If you’ve ever read any of my previous postings you’d see that I like to tailor my DD for the average investor who doesn’t want to spend countless hours researching the research material to decipher it. I also like to keep it short and simple. So with that being said, here’s a quick glance of why I believe this could be a great investment opportunity.
So what is Thermodox?
- Imagine if you will, that you can take an FDA approved chemotherapy drug Doxorubicin and be able to target just the tumor in a much higher concentration (up to 30 times greater than free drug & 3-5 times greater than traditional liposomes) with less exposure to other areas. This is what the Thermodox treatment is. Doxorubicin is coated in a liposomal encapsulation that only melts away when heated by inducing mild hypothermia (hyperthermia means a body temperature that is higher than normal). Radiofrequency ablation (RFA) is the most commonly used type of local hyperthermia. RFA is used to heat up the region of the tumor and therefore releasing the high concentration of the chemotherapy drug to attack the tumor.
Product of Interest to Me
Thermodox: A proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. ThermoDox® is administered intravenously and in combination with hyperthermia. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
CATALYST(s): Interim Analysis - Sept 2011 – (ref: http://bit.ly/kB8gMW Page 14)
OTHER CATALYST(s): Trial enrollment Halt due to sufficient data.
MY BRIEF RISK ANALYSIS: Medium to Below Average for Sept interim. For a longer term investment, your risk increases.
Bear Side: The company has had a couple share offerings in the past couple of months and Thermodox has not previously completed any phase 3 trials. Of the available data involving humans, only 1 patient was treated for primary liver cancer and 5 others for metastatic liver disease. Therefore, little data is available involving humans.
Bull Side: The phase 3 trial is being conducted under a SPA (Special Protocol Assesment) so a trial design failure is reduced significantly. Doxorubicin is already a FDA approved chemotherapy drug, RFA is already used medical procedures, and Liposomal technology has been used since the 1990’s. Celsion is only introducing a capsulated form of the same drug in conjunction with mild hypothermia and releasing the drug in the tumor site. Also, take note of insider buying in the last few months indicating insider confidence in their product.
Slides
DD Links
Celsion Website
http://bit.ly/m92tKL
Celsion 2011 Annual Shareholder Meeting
http://bit.ly/jBY6I9
Griffin Securities Report
http://bit.ly/mfWlRS
Gekkowire's Celsion CLSN report
http://bit.ly/mEQAoI
Biotech Stock Mailbag: Celsion (Adam Feuerstein)
http://bit.ly/kE6qbv
Thermodox Video
http://bit.ly/kUeQLQ
Celsion's ihub page
http://bit.ly/jEuQgp
Insider trades
http://bit.ly/lk8pNU
Other Resource Links
Radiofrequency Ablation of Hepatic Tumors: Increased Tumor Destruction with Adjuvant Liposomal Doxorubicin Therapy
http://bit.ly/mqaG45
Radiofrequency ablation of small hepatocellular carcinoma with intravenous pegylated liposomal doxorubicin
http://1.usa.gov/kjTSv6
Multi-targeting cancer chemotherapy using temperature-responsive drug carrier systems
http://bit.ly/mQ3lCL
$CLSN – My brief Celsion Corporation DD
Friday's open $3.18
Friday's close $3.13
52-week high $3.87
52-week low $1.98
Market capitalization 61.5M
Avg. volume (10-day) 448.0K
Shares outstanding 19.6M
In my opinion, the investment of Celsion at this price with this market capitalization is an absolute steal. Currently, the company is conducting a pivotal Phase III clinical trial for primary liver cancer and a Phase II study for recurrent chest wall breast cancer.
If you’ve ever read any of my previous postings you’d see that I like to tailor my DD for the average investor who doesn’t want to spend countless hours researching the research material to decipher it. I also like to keep it short and simple. So with that being said, here’s a quick glance of why I believe this could be a great investment opportunity.
So what is Thermodox?
- Imagine if you will, that you can take an FDA approved chemotherapy drug Doxorubicin and be able to target just the tumor in a much higher concentration (up to 30 times greater than free drug & 3-5 times greater than traditional liposomes) with less exposure to other areas. This is what the Thermodox treatment is. Doxorubicin is coated in a liposomal encapsulation that only melts away when heated by inducing mild hypothermia (hyperthermia means a body temperature that is higher than normal). Radiofrequency ablation (RFA) is the most commonly used type of local hyperthermia. RFA is used to heat up the region of the tumor and therefore releasing the high concentration of the chemotherapy drug to attack the tumor.
Product of Interest to Me
Thermodox: A proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. ThermoDox® is administered intravenously and in combination with hyperthermia. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
CATALYST(s): Interim Analysis - Sept 2011 – (ref: http://bit.ly/kB8gMW Page 14)
OTHER CATALYST(s): Trial enrollment Halt due to sufficient data.
MY BRIEF RISK ANALYSIS: Medium to Below Average for Sept interim. For a longer term investment, your risk increases.
Bear Side: The company has had a couple share offerings in the past couple of months and Thermodox has not previously completed any phase 3 trials. Of the available data involving humans, only 1 patient was treated for primary liver cancer and 5 others for metastatic liver disease. Therefore, little data is available involving humans.
Bull Side: The phase 3 trial is being conducted under a SPA (Special Protocol Assesment) so a trial design failure is reduced significantly. Doxorubicin is already a FDA approved chemotherapy drug, RFA is already used medical procedures, and Liposomal technology has been used since the 1990’s. Celsion is only introducing a capsulated form of the same drug in conjunction with mild hypothermia and releasing the drug in the tumor site. Also, take note of insider buying in the last few months indicating insider confidence in their product.
Slides
DD Links
Celsion Website
http://bit.ly/m92tKL
Celsion 2011 Annual Shareholder Meeting
http://bit.ly/jBY6I9
Griffin Securities Report
http://bit.ly/mfWlRS
Gekkowire's Celsion CLSN report
http://bit.ly/mEQAoI
Biotech Stock Mailbag: Celsion (Adam Feuerstein)
http://bit.ly/kE6qbv
Thermodox Video
http://bit.ly/kUeQLQ
Celsion's ihub page
http://bit.ly/jEuQgp
Insider trades
http://bit.ly/lk8pNU
Other Resource Links
Radiofrequency Ablation of Hepatic Tumors: Increased Tumor Destruction with Adjuvant Liposomal Doxorubicin Therapy
http://bit.ly/mqaG45
Radiofrequency ablation of small hepatocellular carcinoma with intravenous pegylated liposomal doxorubicin
http://1.usa.gov/kjTSv6
Multi-targeting cancer chemotherapy using temperature-responsive drug carrier systems
http://bit.ly/mQ3lCL
Thank you barefootrunner for that video. As you already know, im knee deep into this one as of today @ 3.16
Don't get me wrong Young, I agree with you that these prices are a gift but only to those who are willing to sit on their hands for an undetermined amount of time.
IMO, it will take time for $CBLI to progress. The major reason for the sell off and probably the reasoning for the dilution was because of the delay with BARDA. They have to resubmit a new proposal and wait for a reply.
BARDA has indicated that the Company may resubmit an updated proposal upon confirmation from the FDA there are no objections to the Company proceeding with its development plan as a result of this review
http://yhoo.it/l3bOY9
I've had this one in my watch list for several months and I'm still undecided to buy or not .... if i do, it'll have to be closer to their catalyst timeframe sept/oct b/c of their financials
I would never take scientific or statistical advise/calculation from a biased investor either short or long. That being said, I would send an e-mail to their management if you're really that interested.
Aschinger Carl J Jr still owns 158k shares
Blair Anthony K left to Devicor
David Bupp is ex-ceo who has established a pre arranged selling plan
that may take place from time-to-time, subject to certain criteria stated in the plan, including certain minimum price levels and daily volume activity
If the insiders were all liquidating their shares for no reason, then its a sign of concern. This IMO is not the case
Not necessarily; the enterprise value of $350M+ remains bloated, IMO. The stock has been heavily pumped in the past few months, not only by posters on iHub, but also by one of NEOP’s non-executive directors. Insiders are now selling.
I'm going to give my opinion on this matter. Since the collapse of RIGS in the 1990's and under David Bupp's direction, they approached the FDA with the utmost caution. Before conducting their trials, they would meet with the FDA to discuss everything to death before proceeding. It drove long term investors crazy because everything took so long to develop. The approach to the trials neo3-05 and neo3-09 were not treated any different.
As Mark Pykett (CEO) explained in one of the latest CC's..
"The clinical trial design process was exhaughsted. Neoprobe consulted multiple clinical investigators on the design of the trial and continually engaged the FDA including extensive discussions on trial endpoint. The basic non inferiority design of neo3-05 and 09 trials was essentially identical between the 2 protocols. The FDA has reviewed the protocol design not once but twice and has reviewed results from one trial while offering recommendation and guidance on the second trial. That is why we are confident in the design, regulatory positioning, clinical value, and findings of lymphoseek clinical studies and what they mean to the agent and more importantly to the potential impact on patient care."
Important Notes I've taken for Neoprobe's $NEOP Lymphoseek and Trial Design
All of the quotes below are taken from the lastest conference calls since the news of NEO3-09 results.
- Lymphoseek Trial Design Commentary and the How the FDA played a Role
Mark Pykett - Neoprobe Corp. - President, CEO
"Vital blue dye is the only FDA approved on label agent used in in clinical practice in the US for ILM procedures. It is the only on-label agent. In a non inferiority design aginst the standard of care, the FDA requires a comparison to the on-label agent and will not endorse studies to off-label agents in this case, sulfur colloid. To gain approval in the US, FDA would not allow a comparison to an off-label agent. So a study against sulfur colloid would not have supported approval.""
Mark Pykett - Neoprobe Corp. - President, CEO
"The clinical trial design process was exhaughsted. Neoprobe consulted multiple clinical investigators on the design of the trial and continually engaged the FDA including extensive discussions on trial endpoint. The basic non inferiority design of neo3-05 and 09 trials was essentially identical between the 2 protocols. The FDA has reviewed the protocol design not once but twice and has reviewed results from one trial while offering recommendation and guidance on the second trial. That is why we are confident in the design, regulatory positioning, clinical value, and findings of lymphoseek clinical studies and what they mean to the agent and more importantly to the potential impact on patient care."
Mark Pykett - Neoprobe Corp. - President, CEO
"Additionally, as we have discussed previously, we also believe Lymphoseek offers significant advantages over generic sulfur colloid agents typically utilized off-label in connection with vital blue dye in lymphatic mapping procedures. We believe it is reasonable to view Lymphoseek as an agent that potentially offers the opportunity to replace these two combined agents with one agent in lymph node mapping procedures, as well as an agent with reliable procedural characteristics that can improve clinic workflow and productivity compared to that achieved with the current standard of care agents."
Mark Pykett - Neoprobe Corp. - President, CEO
"An analysis of the composite data for both (technical difficulty) Phase III studies revealed a false negative rate for Lymphoseek of 0.01% and a false negative rate of vital blue dye of 22.76%. Lymphoseek's substantially lower failed detection rate means that it missed fewer lymph nodes containing cancer, a key finding given that the objective of intraoperative lymphatic mapping is to determine if the cancer has spread to the lymph nodes. This is very important because the goal of intraoperative lymphaticmapping is to determine if indeed the cancer has spread to the lymph node."
Mark Pykett - Neoprobe Corp. - President, CEO
"There are several key takeaways from the NEO3-09 data. First, the study met all of its primary and secondary endpoints. Second, the primary endpoint of concordance was highly statistically significant. Third, Lymphoseek showed better detection of lymph nodes in a reverse concordance analysis. Fourth, the pre-specified test for Lymphoseek superiority was highly statistically significant as well. Fifth, Lymphoseek's failed detection rate was zero, substantially lower than vital blue dye's failed detection rate, meaning that it was better at detecting lymph nodes that had cancer, which may be the most important element of superiority and is the whole point of doing the lymph node biopsy procedure. Finally, Lymphoseek continued to show a very strong safety profile with no serious or significant drug-related adverse events reported, both in this study and in the overall population of over 500 patients in all studies to date"
"Stephen Dunn - LifeTech Capital - Analyst
Great. Are you looking then -- in your opening comments, it appeared that you're looking for -- to market this to replace both vital blue dye and [T-99] in combination or as the model was vital blue dye. So you're planning on marketing this as a mono to replace those two?
Mark Pykett - Neoprobe Corp. - President, CEO
We believe that, because of the superiority that we've demonstrated against the vital blue dye in this study as well as the superior performance characteristics against sulfur colloid, that it is reasonable to view and we do view Lymphoseek as an agent with an opportunity to replace two standard agents with one, with Lymphoseek. I think that's an important point in terms of product positioning."
Important Notes I've taken for Neoprobe's $NEOP Lymphoseek and Trial Design
All of the quotes below are taken from the lastest conference calls since the news of NEO3-09 results.
- Lymphoseek Trial Design Commentary and the How the FDA played a Role
Mark Pykett - Neoprobe Corp. - President, CEO
"Vital blue dye is the only FDA approved on label agent used in in clinical practice in the US for ILM procedures. It is the only on-label agent. In a non inferiority design aginst the standard of care, the FDA requires a comparison to the on-label agent and will not endorse studies to off-label agents in this case, sulfur colloid. To gain approval in the US, FDA would not allow a comparison to an off-label agent. So a study against sulfur colloid would not have supported approval.""
Mark Pykett - Neoprobe Corp. - President, CEO
"The clinical trial design process was exhaughsted. Neoprobe consulted multiple clinical investigators on the design of the trial and continually engaged the FDA including extensive discussions on trial endpoint. The basic non inferiority design of neo3-05 and 09 trials was essentially identical between the 2 protocols. The FDA has reviewed the protocol design not once but twice and has reviewed results from one trial while offering recommendation and guidance on the second trial. That is why we are confident in the design, regulatory positioning, clinical value, and findings of lymphoseek clinical studies and what they mean to the agent and more importantly to the potential impact on patient care."
Mark Pykett - Neoprobe Corp. - President, CEO
"Additionally, as we have discussed previously, we also believe Lymphoseek offers significant advantages over generic sulfur colloid agents typically utilized off-label in connection with vital blue dye in lymphatic mapping procedures. We believe it is reasonable to view Lymphoseek as an agent that potentially offers the opportunity to replace these two combined agents with one agent in lymph node mapping procedures, as well as an agent with reliable procedural characteristics that can improve clinic workflow and productivity compared to that achieved with the current standard of care agents."
Mark Pykett - Neoprobe Corp. - President, CEO
"An analysis of the composite data for both (technical difficulty) Phase III studies revealed a false negative rate for Lymphoseek of 0.01% and a false negative rate of vital blue dye of 22.76%. Lymphoseek's substantially lower failed detection rate means that it missed fewer lymph nodes containing cancer, a key finding given that the objective of intraoperative lymphatic mapping is to determine if the cancer has spread to the lymph nodes. This is very important because the goal of intraoperative lymphaticmapping is to determine if indeed the cancer has spread to the lymph node."
Mark Pykett - Neoprobe Corp. - President, CEO
"There are several key takeaways from the NEO3-09 data. First, the study met all of its primary and secondary endpoints. Second, the primary endpoint of concordance was highly statistically significant. Third, Lymphoseek showed better detection of lymph nodes in a reverse concordance analysis. Fourth, the pre-specified test for Lymphoseek superiority was highly statistically significant as well. Fifth, Lymphoseek's failed detection rate was zero, substantially lower than vital blue dye's failed detection rate, meaning that it was better at detecting lymph nodes that had cancer, which may be the most important element of superiority and is the whole point of doing the lymph node biopsy procedure. Finally, Lymphoseek continued to show a very strong safety profile with no serious or significant drug-related adverse events reported, both in this study and in the overall population of over 500 patients in all studies to date"
"Stephen Dunn - LifeTech Capital - Analyst
Great. Are you looking then -- in your opening comments, it appeared that you're looking for -- to market this to replace both vital blue dye and [T-99] in combination or as the model was vital blue dye. So you're planning on marketing this as a mono to replace those two?
Mark Pykett - Neoprobe Corp. - President, CEO
We believe that, because of the superiority that we've demonstrated against the vital blue dye in this study as well as the superior performance characteristics against sulfur colloid, that it is reasonable to view and we do view Lymphoseek as an agent with an opportunity to replace two standard agents with one, with Lymphoseek. I think that's an important point in terms of product positioning."
thank you Sheff
Thank you
np cabos, i cant stand low quality bashing of my stock and people's acceptance of it
My thoughts on $NEOP Seeking Alpha Article titled: "The Short Case for Neoprobe: Skeptical of Its Primary Asset's Success" link http://bit.ly/k9aejl
This will be my last article regarding Neoprobe simply because I have come to realize that no matter how much I, or anyone else for that matter, writes about it, the bears will always misrepresent any company they want to and manipulate its price. With that being said, those bursts of bearish movements always come back to reality when a company has the fundamentals in place to keep moving forward. I could put in a lot more time into this but I have decided that Neoprobe management will take care of it all this weekend at ASCO.
Now, I’m going to pick this bearish and incompetent article piece by piece.
Author: “The current standard of care for sentinel lymph node biopsy is the combination of a blue dye (isosulfan blue or methylene blue) and a radioactive technetium-99 sulfur colloid. This combination results in the identification of a sentinel lymph node upwards of 95% of the time[1].”
My Reply: Here is the author's reference piece for [1].
Background: Sentinel lymph node biopsy (SLNB) is commonly performed using radioisotope and/or blue dye. However, it is still undefined which reagent is more suitable for identifying sentinel lymph nodes(SLN). Methods: A consecutive series of 640 breast cancer patients who underwent SLNB at Keio University Hospital in Japan from January 2001 to June 2006 was analyzed. The SLN was identified by a combination of technetium-99m tin colloid and isosulfan blue dye. The correlation between clinicopathological factors and the distribution of radioisotope and blue dye was analyzed. A SLN found to be the single metastatic lymph node by axillary lymph node dissection was considered as "true SLN", since this SLN was the only metastatic lymph node among entire axillary nodes, suggesting it may be the first lymph node in a regional lymphatic basin that received lymphatic flow from the primary tumor. 73 cases with "true SLN" were extracted to verify the efficiency of radioisotope and blue dye as a tracer of SLN. Results: In 640 cases, the total number of SLNs successfully identified was 1558 from 625 (97.8%) cases. SLNs showing both hot and blue were present in 491 cases (76.7%), whereas blue nodes alone were present in 19 cases (3.0%) and the presence of hot nodes alone were detected in 115 cases (18.0%) There was no significant correlation between clinicopathological features and the distribution of those reagents to the SLNs. Among 73 "true SLN" cases, 70 (95.9%) cases were successfully mapped. In these cases, 48 (65.7%) "true SLN" showed both hot and blue, and 22 (30.1%) showed hot alone, however, there was no "true SLN" showing blue alone. Conclusions: Addition of blue dye to radioisotope increased the successful mapping rate by 3.0%, but did not enhance the identification rate of "true SLN". Combination of radioisotope and blue dye is considered to be a more useful methodology for detection of SLNs than either reagent alone, however under the situation that one must be chosen, radioisotope should be better answer.
The need for further nodal dissection after sentinel node biopsy has been challenged as well. A recent study from The American College of Surgeons Oncology Group (Z0011 trial) was published on February 9, 2011 in the Journal of theAmerican Medical Association.7The objective of the study was to determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node metastasis of breast cancer. This was a noninferiority trial conducted at 115 sites enrolling 891 patients from May 1999 to December 2004. All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by sentinel lymph node biopsy (SLNB) were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 in rder to indicate that SLNB alone is non-inferior to ALND. Disease free survival was a secondary endpoint. Randomization was 445 patients toALND and 446 randomized to SLNB alone. The median number of nodes removed was 17 with ALND and 2 with SLNB alone. The results among patients were the use of SLNB alone compared with ALND did not result in inferior survival. In fact, though small, the survival rate for SLNB alone was larger than ALND in the later years of the analysis. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% with ALND and 92.5% with SLNB alone. 5-year disease-free survival was 82.2% with ALND and 83.9% with SLNB alone. While the utility of axillary lymph node dissections may be disputed, the importance of sentinel node biopsy procedures is only underscored by these results.
My thoughts on $NEOP Seeking Alpha Article titled: "The Short Case for Neoprobe: Skeptical of Its Primary Asset's Success" link http://bit.ly/k9aejl
This will be my last article regarding Neoprobe simply because I have come to realize that no matter how much I, or anyone else for that matter, writes about it, the bears will always misrepresent any company they want to and manipulate its price. With that being said, those bursts of bearish movements always come back to reality when a company has the fundamentals in place to keep moving forward. I could put in a lot more time into this but I have decided that Neoprobe management will take care of it all this weekend at ASCO.
Now, I’m going to pick this bearish and incompetent article piece by piece.
Author: “The current standard of care for sentinel lymph node biopsy is the combination of a blue dye (isosulfan blue or methylene blue) and a radioactive technetium-99 sulfur colloid. This combination results in the identification of a sentinel lymph node upwards of 95% of the time[1].”
My Reply: Here is the author's reference piece for [1].
Background: Sentinel lymph node biopsy (SLNB) is commonly performed using radioisotope and/or blue dye. However, it is still undefined which reagent is more suitable for identifying sentinel lymph nodes(SLN). Methods: A consecutive series of 640 breast cancer patients who underwent SLNB at Keio University Hospital in Japan from January 2001 to June 2006 was analyzed. The SLN was identified by a combination of technetium-99m tin colloid and isosulfan blue dye. The correlation between clinicopathological factors and the distribution of radioisotope and blue dye was analyzed. A SLN found to be the single metastatic lymph node by axillary lymph node dissection was considered as "true SLN", since this SLN was the only metastatic lymph node among entire axillary nodes, suggesting it may be the first lymph node in a regional lymphatic basin that received lymphatic flow from the primary tumor. 73 cases with "true SLN" were extracted to verify the efficiency of radioisotope and blue dye as a tracer of SLN. Results: In 640 cases, the total number of SLNs successfully identified was 1558 from 625 (97.8%) cases. SLNs showing both hot and blue were present in 491 cases (76.7%), whereas blue nodes alone were present in 19 cases (3.0%) and the presence of hot nodes alone were detected in 115 cases (18.0%) There was no significant correlation between clinicopathological features and the distribution of those reagents to the SLNs. Among 73 "true SLN" cases, 70 (95.9%) cases were successfully mapped. In these cases, 48 (65.7%) "true SLN" showed both hot and blue, and 22 (30.1%) showed hot alone, however, there was no "true SLN" showing blue alone. Conclusions: Addition of blue dye to radioisotope increased the successful mapping rate by 3.0%, but did not enhance the identification rate of "true SLN". Combination of radioisotope and blue dye is considered to be a more useful methodology for detection of SLNs than either reagent alone, however under the situation that one must be chosen, radioisotope should be better answer.
The need for further nodal dissection after sentinel node biopsy has been challenged as well. A recent study from The American College of Surgeons Oncology Group (Z0011 trial) was published on February 9, 2011 in the Journal of theAmerican Medical Association.7The objective of the study was to determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node metastasis of breast cancer. This was a noninferiority trial conducted at 115 sites enrolling 891 patients from May 1999 to December 2004. All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by sentinel lymph node biopsy (SLNB) were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 in rder to indicate that SLNB alone is non-inferior to ALND. Disease free survival was a secondary endpoint. Randomization was 445 patients toALND and 446 randomized to SLNB alone. The median number of nodes removed was 17 with ALND and 2 with SLNB alone. The results among patients were the use of SLNB alone compared with ALND did not result in inferior survival. In fact, though small, the survival rate for SLNB alone was larger than ALND in the later years of the analysis. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% with ALND and 92.5% with SLNB alone. 5-year disease-free survival was 82.2% with ALND and 83.9% with SLNB alone. While the utility of axillary lymph node dissections may be disputed, the importance of sentinel node biopsy procedures is only underscored by these results.
1. it eliminates the need for dilutive financing
- near term, yes, long term 1.5 yr+, perhaps not (only cause of development for rigs and possible acquisition(s))
2. it monetizes an asset that I didn't know NEOP had, and that I did not care about, and which I doubt anyone playing NEOP attached any value to.
- it was their only revenue, so yes they did value this but felt it more important to pursue lymphoseek and develop rigs
3. they got a good price - someone else posted (on YMB?) that this was 3 years worth of revenue from a sector that had been declining
- they got a great price for it and they were averaging 9M annually, so the 30M cash + up to 20M more later is a great price
4. with cash in hand NEOP can develop their drug once approved
- they can pursue a wider range of usage (other then breast cancer, melanoma, head and neck cancer) with lymphoseek through clinical trials while concurrently develop RIGS (1.5B+ sleeper)
5. although NEOP still could partner, or ultimately agree to a buyout, the cash allows them to deal from strength and get a better deal if they choose to deal
- they already have the best partner in the radio pharmaceutical area with cardinal health. albeit, it won't suprise me if cardinal just flat out buys them out
6. NEOP is now a pure drug play and should be awarded higher multiples accordingly
- yup
7. It strongly signals that management is confident of approval
- absolutely
8. as a pure play, NEOP now becomes a cleaner company to buy if a big pharma company wanted to do so
- yup, concentrating your business into 1 particular sector makes you more attractive
Additional Notes: They now have cash to advance RIGScan, which at one point in time took their pps from 1.50 all the way to the mid to upper 19's before the fda denied the application. Several years later, they found that the patients who used rigscan during the trials had a correlation with overall survivability. As shown in the graph below.
Lymphoseek has not been priced yet, so the estimates of the market cap that you see floating around are not accurate. I suspect that because Lymphoseek is a superior product and will be insurance reimbursable, you will see a higher price tag then the mkt cap of 450M you see floating around. Add RIGScan to this picture and this company can easily have a 2-3B mkt cap 1 to 1.5 years from now.
I jumped the gun on this one I think. After several re-readings, I can see that the holders of pref shares can voluntarily convert their prior to July 7. If they don't convert prior to that date, it will be converted for them on that effective date.
Since I'm not certain whether or not the voluntary conversion will be more beneficial now rather then later for the pref or common share holders. Therefore, I will leave it to the finance experts to figure this out. Sorry if I confused any of you
Given this news and the circumstances surrounding the financing of the company, this is great news. The "dilution risk" that has been surrounding them with the public sentiment has been addressed by this move. Take note that the date of the conversion "July 7, 2011" is after the PDUFA date, "June 22, 2011".
Let the runup continue.
Thanks $heff.
Thanks $heff for the DD you've provided. I have started a position at 1.14 this morning and will also be holding through PDUFA.
On top of the DD you have provided, I have also noticed this past weekend that one of the people I respect the most in biotech is also involved. It was this same reason that leaned me into buying into FCSC.
FROM http://www.nih.gov/about/people/langer.htm
Robert Langer is an engineer who wants to change the world. He's bringing industry along for the ride.
Biorubber, microspheres, timed-release polymers, transdermal patches. Robert S. Langer, Sc.D., is a long-time NIH grantee who has had a hand in developing all kinds of innovative ways to engineer new tissue and deliver drugs to their precise targets in the body. Burn victims and patients with certain cancers and heart disease are better for it.
"I'm an engineer. I try to solve problems," Langer says. His reasoned approach has yielded more than 500 patents; more than 40 products resulting from his work are now on the market or in human testing. "I want to see science do good, to help people," says Langer, a professor of chemical and biomedical engineering at the Massachusetts Institute of Technology in Boston.
The 55-year-old's success in that endeavor has earned him accolades from every corner. Discover Magazine named him one of the 20 most important people in medical technology. Forbes selected him as one of the 15 innovators worldwide who will reinvent our future. In 2002, Langer won the $500,000 Draper Award, engineering's version of the Nobel Prize.
Throughout his career, Langer has received major support from the NIH. Today, he has grants from five NIH institutes. "The NIH has been the single biggest supporter of our lab," he says. "It enables us to do research. The money gives you the freedom to come up with the ideas you come up with—and those ideas can hopefully change the world in a better way."
"The NIH's investment is amplified enormously by biotech companies," he adds. For example, the field that he helped launch, controlled drug delivery, includes things like transdermal patches used for nicotine replacement therapy, inhalation therapy being studied for diseases such as diabetes, and druginfused microchips. It is a $20 billion U.S. industry. In terms of health benefits, Langer claims, more than 10 million people in the United States alone use these kinds of systems.
Early in his career, Langer realized that industry had to figure prominently if he wanted his inventions to reach the public. The private sector has the capacity and expertise to do final-stage testing, large-scale manufacturing, and obtain Food and Drug Administration approvals that academia does not. At first, he was swimming against the tide. Now he's seen as a visionary. He told the Boston Globe in a May 2003 article, "Some academics feel science should be pure, so they avoid interactions with companies. But when done well, I think the benefits are enormous—in treatments for disease, in new companies, in jobs." Langer has launched at least a dozen biotech firms and advises several more. More than 100 companies hold licenses to his patents. That means his discoveries reach the marketplace to help people.
One example is the Gliadel Wafer. In the mid-1980s, Langer and Henry Brem, M.D., a neurosurgeon at the Johns Hopkins University who had worked with Langer in the lab of renowned cancer researcher Judah Folkman, M.D., created a dime-size wafer to deliver chemotherapy directly to a site in the brain where a tumor has been removed. The Gliadel Wafer became the first therapy in more than two decades to extend the lives of patients with a deadly brain cancer called glioblastoma.
Langer and colleagues in June 2002 reported development of a new flexible plastic called biorubber. Biorubber can be impregnated with medicine or serve as a scaffold that can stretch and snap back like a rubber band, similar to human tissues such as the lungs' air sacs. The researchers are sharing samples with scientists around the world to test biorubber's utility in various settings.
Langer's work has also made possible the drug-eluting stent, which became available to patients with heart disease in 2003. Used for patients with life-threatening narrowing of the arteries, one such stent is marketed by Johnson & Johnson and coated with a drug called rapamycin that is slowly released into the blood vessel to prevent restenosis—narrowing of the vessel that the stent was used to widen. He says he expects the new stents will save 100,000 lives. Sounds like Langer is making good on his goal of changing the world, thousands of patients at a time.
I follow the progressions of $VVUS since I keep it on my watch list. I do believe that it will get the fda nod next time around however, Avanafil will be a dead on arrival product IMO unfortunately. The market is overcrowded with ED products including one by GSK/Merck called Staxyn last year which is IMO better then Avanafil.
If you want more info on VVUS I recommend you follow @TroKalayjian on twitter, he's big on em.
thanks bud
Jim, I am playing the catalysts on this one.
- potential partnership
- nda submission
- panel
- pdufa
This concern is already described in detail in Jason's report. Here's the copy/paste
Alexza has spent the past few months analyzing the data from the pulmonary safety programs and from the phase 3 trial. The company hired outside consultants to help analyze if there is a safety concern with Staccato or AZ-004. Some of the key points that management made in their discussion with the FDA
- All respiratory symptoms that developed after treatment in the phase 1 study were either self-limiting (resolved spontaneously) or readily managed with an inhaled bronchodilator.
- No intravenous intervention was necessary due to respiratory side-effects in either the phase 1 pulmonary safety study or the pivotal phase 3 program.
- There were no serious adverse events (SAEs) in the phase 1 or the phase 3 pivotal program. Respiratory events in the phase 3 program (~750 patients) were less than 1%.
- During the clinical trials, use of standard bronchodilators was prohibited while on drug
Alexza believes it has presented evidence that the placebo device is safe, including a blinded expert review of the flow-volume loops data from the healthy subject study as further evidence that there appears to be no meaningful or consistent pattern suggestive of airway obstruction in these subjects. Alexza also provided an analysis showing that there is no meaningful temporal relationship between placebo administration and decreases in FEV1. Management believes this evidence and analysis confirms that the changes seen were likely background events in the population studied, where the repeated and extensive pulmonary function testing may have contributed to some of the observations. Management plans to include this information in the new filing for approval.
The information that Alexza has complied over the past several months on the pulmonary safety will also help develop a Risk Evaluation and Mitigation Strategy (REMS) program designed to identify potential subjects that could exhibit pulmonary safety issues on AZ-004 (e.g. patients with asthma and COPD). The FDA noted at the meeting in December 2010 that it would be reasonable to propose a REMS program for the use of Staccato loxapine, and requested that as part of the company's resubmission.
We note in April 2011, Alexza met again with the FDA for a Type-C meeting to discuss the proposed REMS and the key elements within the REMS for screening at risk patients prior to taking AZ-004. At this meeting, the FDA emphasized that there are two key components for a risk mitigation proposal: 1) Adequacy of monitoring, via patient observation, for a period of time relative to the likely occurrence of a respiratory adverse reaction, and 2) Availability of rescue medication (e.g., inhaled albuterol) should an adverse reaction occur.
Alexza plans to address this updated guidance from the FDA in its draft REMS proposal contained within the AZ-004 NDA resubmission. The FDA indicated that a complete review of the proposed REMS in conjunction with the full clinical review of the resubmitted NDA will be necessary to determine whether the REMS will be acceptable. The FDA stated it would present the AZ-004 application to an Advisory Committee. The objective of this Advisory Committee meeting would be to discuss the proposed approach for managing the risks of AZ-004 in relationship to its patient benefits. We believe this is good news. It allows Alexza management to discuss the pulmonary safety of Staccato in an open, back-and-forth, dialogue with the FDA. It also allows shareholders to listen in and make an investment decision prior to the actual PDUFA date.
$ALXA -Alexza Pharmaceuticals DD
Current Price 1.40
Previous Close 1.38
Open 1.39
Avg Daily Vol (13 Wks) 576,141
52-Wk High 3.68
52-Wk Low 0.86
In my opinion Alexza Pharmaceuticals is positioned well to have a decent 2nd half of 2011 runup based on their development efforts to address their latest CRL and a few near term potential catalysts. As a plus, the dilution risk that most biotech companies have has been mitigated to a low risk assessment on my part due to their recent offering on 5/10/2011.
Product of Interest to Me
AZ-004: Staccato Loxapin
INTENDED INDICATION: Acute Treatment of Agitation associated with Schizophrenia or Bipolar Disorder.
PATIENT POPULATION: 2.4 million schizophrenia patients and 5.7 million bipolar disorder patients in the United States; agitation is a common and severe symptom.
STATUS: Successfully completed two Phase 3 trials: a 344-patient trial for schizophrenia and a 314-patient trial for bipolar disorder. Both trials met primary and secondary endpoints. The company submitted an NDA in December 2009, and a Complete Response Letter was issued by FDA on October 8, 2010.
CATALYST(s): NDA resubmission in 3rd Quarter (July target), MAA Filing, and Panel/PDUFA Run up
OTHER CATALYST(s): Management has made it clear they would want to have a partnership/agreement deal done before their NDA submission.
MY BRIEF RISK ANALYSIS: Minimal, company already had enough cash on hand to fund for 1 yr before their direct offering at the price of 1.35 on 5/3/2011. They have addressed 3 of the 4 concerns noted in the FDA CRL they received last year and believe that they have the sufficient data (~750 patients) needed to address the 4th concern. Basically, there is more upside then downside at this point in time with the PPS ranging in the 1.35 – 1.40 PPS range.
DD Links
Zacks Report (Jason Napodano) http://bit.ly/lGX9Rb
Most Recent Webcast (5/10/2011) http://bit.ly/jBBkso
ALXA Sec Filings: http://1.usa.gov/mF0Fbk
SA Article http://bit.ly/lIaanV
Staccato Visual and Details http://bit.ly/iCBolK
Other things to Note
5/16/2011 NEW Form SC 13G SEC Filing http://1.usa.gov/lre4Tz
Reporting Persons: RA Capital Management, LLC, Peter Kolchinsky, RA Capital Healthcare Fund, L.P.
In the aggregate, the Reporting Persons beneficially own 3,975,678 shares of the Common Stock of the Issuer, representing approximately 5.5% of such class of securities
5/16/2011 NEW Form SC 13G SEC Filing http://1.usa.gov/kgCTyx
Reporting Persons: Boxer Capital, LLC, Boxer Asset Management Inc, MVA Investors LLC, Aaron Davis, Joseph Lewis
The Reporting Persons may be deemed to beneficially own 4,609,709 Common Shares which constitute approximately 6.4% of a notional number of the Issuer’s outstanding Common Shares
$ALXA -Alexza Pharmaceuticals DD
Current Price 1.40
Previous Close 1.38
Open 1.39
Avg Daily Vol (13 Wks) 576,141
52-Wk High 3.68
52-Wk Low 0.86
In my opinion Alexza Pharmaceuticals is positioned well to have a decent 2nd half of 2011 runup based on their development efforts to address their latest CRL and a few near term potential catalysts. As a plus, the dilution risk that most biotech companies have has been mitigated to a low risk assessment on my part due to their recent offering on 5/10/2011.
Product of Interest to Me
AZ-004: Staccato Loxapin
INTENDED INDICATION: Acute Treatment of Agitation associated with Schizophrenia or Bipolar Disorder.
PATIENT POPULATION: 2.4 million schizophrenia patients and 5.7 million bipolar disorder patients in the United States; agitation is a common and severe symptom.
STATUS: Successfully completed two Phase 3 trials: a 344-patient trial for schizophrenia and a 314-patient trial for bipolar disorder. Both trials met primary and secondary endpoints. The company submitted an NDA in December 2009, and a Complete Response Letter was issued by FDA on October 8, 2010.
CATALYST(s): NDA resubmission in 3rd Quarter (July target), MAA Filing, and Panel/PDUFA Run up
OTHER CATALYST(s): Management has made it clear they would want to have a partnership/agreement deal done before their NDA submission.
MY BRIEF RISK ANALYSIS: Minimal, company already had enough cash on hand to fund for 1 yr before their direct offering at the price of 1.35 on 5/3/2011. They have addressed 3 of the 4 concerns noted in the FDA CRL they received last year and believe that they have the sufficient data (~750 patients) needed to address the 4th concern. Basically, there is more upside then downside at this point in time with the PPS ranging in the 1.35 – 1.40 PPS range.
DD Links
Zacks Report (Jason Napodano) http://bit.ly/lGX9Rb
Most Recent Webcast (5/10/2011) http://bit.ly/jBBkso
ALXA Sec Filings: http://1.usa.gov/mF0Fbk
SA Article http://bit.ly/lIaanV
Staccato Visual and Details http://bit.ly/iCBolK
Other things to Note
5/16/2011 NEW Form SC 13G SEC Filing http://1.usa.gov/lre4Tz
Reporting Persons: RA Capital Management, LLC, Peter Kolchinsky, RA Capital Healthcare Fund, L.P.
In the aggregate, the Reporting Persons beneficially own 3,975,678 shares of the Common Stock of the Issuer, representing approximately 5.5% of such class of securities
5/16/2011 NEW Form SC 13G SEC Filing http://1.usa.gov/kgCTyx
Reporting Persons: Boxer Capital, LLC, Boxer Asset Management Inc, MVA Investors LLC, Aaron Davis, Joseph Lewis
The Reporting Persons may be deemed to beneficially own 4,609,709 Common Shares which constitute approximately 6.4% of a notional number of the Issuer’s outstanding Common Shares
Jim Cramer has added $EXEL, $INCY, $NKTR, and $NEOP to his biotech watch http://bit.ly/kJ2A2U
Note: I dont care much for Cramer, but it brings visibility to some of the companies we follow here
re: $AMRN
Thanks, was about to post it as I read yours already... here's the link http://bit.ly/jYLXlg
Thank you Rainmaker for the DD you have provided. I have looked at the information you provided and other DD information around the web including their latest webcast and SEC filings.
I will not be investing in this company. You can send me a PM if you want more info. Good luck and wish you the best.
This one move def put $NSPH in my radar. I will dig deeper into them this weekend. Thanks for sharing this Rainmaker!
To add on this, they noted in the CC (still ongoing) that it is the fiduciary responsibility of the company to have the S-3 if and when it is needed
$AMRN plans on submitting NDA Q3 http://bit.ly/mkEnKk