NeoGenomics: Poised To Grow Further In 2013 And Beyond [View article]
NEO will turn profitable in 1Q13, full year EPS will be $0.04 per share based on revenue of $70 million according to my model. see the below link for details.
Atossa Genetics: Room For Further Price Appreciation [View article]
I don't know how much FedMed will reimburse Atossa. As long as it reimburse Atossa, it's good for Atossa.
Atossa just began limited marketing of ForeCYTE and ArgusCYTE at the end of last year, therefore revenue for the last quarter of 2012 was minimal, this is reasonable. Atossa, together with Clarity Women's Health, formally launched the ForeCYTE Test nationally on January 14, 2013.
With the expansion of its reimbursement network, sales should pick up in 2013. Even with this, my estimate for 2013 sales is only $3.15 million, which is conservative in my view. But sales will accelerate beyond 2013. Of course, the sales ramp should be closely watched in the next few quarters.
I am also optimistic about the diagnostics business in general which has a decent growth in the past few years and will continue the trend in the years to come.
My analysis of Atossa is based on the fundamentals of the Company, not only the FedMed event.
Advaxis (ADXS) Is On Track To Achieve 2012 Goals [View instapost]
They are very encouraging. 12-month survival rate is 31% compared to historical control of 5%. Although this is still a small population trial, it warrants further investigation.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
I agree that the historical control (Stupp trial) is not a perfect substitute for the IMUC Phase I trial. I want to emphasize that it’s a common practice to compare clinical trial results to the Stupp study results for the treatment of glioblastoma, especially for Phase I trials since there is very limited treatment options on the market right now.
I also would like to emphasize that in addition to the historical comparison, IMUC also compared its ICT-107 vaccine against a tumor lysate vaccine trial conducted at the same time. These two trials (ICT-107 and tumor lysate) used the same surgeons, same center and same inclusion criteria in terms of the level of resection and age of patients. The vaccines were given about 5 months post-surgery in both the cases. ICT-107 was given to all patients with HLA-A1/A2 as the antigens are designed to respond only in those patients and all non-HLA A1/A2 were given tumor lysate vaccine from their own tumors. HLA type is not known to have any bias towards survival (just like various blood types don’t have any bias towards cancer survival).
There was a statistically significant increase in overall survival from 20.2 months for tumor lysate to 38.4 months for ICT-107 even with such a small number of patients. Median PFS also significantly increased from 9.3 months for tumor lysate vaccine to 16.9 months for ICT-107.
Although, this was not a prospective study design and not randomized, this further validates the clinical data and shows that patient selection hasn’t played a key role here.
Even the Phase I design was not perfect; the data are very impressive to me. The most important thing is that we all agree that the Phase II trial is really a well-designed study to demonstrate efficacy by comparing it to a control group that gets a dummy vaccine.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
IMUC's active immunotherapy technology is dendritic cell (DC) -based vaccine. Both ICT-107 and ICT-121 are CD-based. The difference between ICT-107 and ICT-121 is that ICT-107 is activated by cellular antigens, while ICT-121 is activated by a peptide (CD-133). The company calls ICT-121 off the shelf vaccine because the antigen CD-133 is ready to use, could be synthesized in lab, not like cellular antigens.
ICT-107 is an add-on therapy to the soc in both Phase I and Phase II trials. The major point is to see the difference between the SOC and SOC+ICT-107. Therefore, I am not very much concerned about the patient status. Of course, Phase II is a much better controlled trial.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
This is the first time I got the confirmation that IMUC will be seeking AMEX listing. Right now, it seems that IMUC meets the standard, but it's not a sure thing for it. Because the exchange will also conducts a subjective review of all listing candidates. Things will be looked at include nature of a company's business; market for its products; reputation of its management; historical record and pattern of growth; financial integrity; demonstrated earnings power; and future outlook.
I believe management will try their best to be successful because it will benefit the company as well as its shareholders.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
Actually, I am also positive on ADXS. Preliminary results from two phase II clinical trials for cervical cancer and CIN are both encouraging. The Company should be able to find a partner after the trials are finished. If this deal can materialize, share price will soar. Cash burn is a little concern. Until they can find a partner, dilutive financing is necessary to advance these trials.
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
Sorry for being late responding to your comments.
I think ONTY is a very decent company. Pipeline is very strong, very diversified, and has many middle to late stage candidates. Pipeline targets huge cancer markets such as NSCLC, Brain cancer, head & neck cancer.
Balance is also very strong. Cash burn is not an issue right now for the Company.
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
Management did not indicate how long the enrollment will take. The Company is currently on track for the initiation of approximately 100 investigator sites in the U.S. and abroad.
We may get some clue when the data safety monitoring board finishes an interim analysis for safety and futility after 70 events.
ATOS: Any Retreat In Share Price Should Provide A Good Entry Opportunity [View instapost]
TKMR Is On Track To Advance TKM-Ebola Program [View instapost]
One statistics is that since 2001, government has spend about $8 billion on 12 defined supplier contracts.
NeoGenomics: Poised To Grow Further In 2013 And Beyond [View article]
http://bit.ly/11jngdn
Atossa Genetics: Room For Further Price Appreciation [View article]
Atossa just began limited marketing of ForeCYTE and ArgusCYTE at the end of last year, therefore revenue for the last quarter of 2012 was minimal, this is reasonable. Atossa, together with Clarity Women's Health, formally launched the ForeCYTE Test nationally on January 14, 2013.
With the expansion of its reimbursement network, sales should pick up in 2013. Even with this, my estimate for 2013 sales is only $3.15 million, which is conservative in my view. But sales will accelerate beyond 2013. Of course, the sales ramp should be closely watched in the next few quarters.
I am also optimistic about the diagnostics business in general which has a decent growth in the past few years and will continue the trend in the years to come.
My analysis of Atossa is based on the fundamentals of the Company, not only the FedMed event.
A Great Move For Galena Biopharma [View article]
Galena Shares Are Attractive [View article]
Galena Shares Are Attractive [View article]
Advaxis (ADXS) Is On Track To Achieve 2012 Goals [View instapost]
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
I also would like to emphasize that in addition to the historical comparison, IMUC also compared its ICT-107 vaccine against a tumor lysate vaccine trial conducted at the same time. These two trials (ICT-107 and tumor lysate) used the same surgeons, same center and same inclusion criteria in terms of the level of resection and age of patients. The vaccines were given about 5 months post-surgery in both the cases. ICT-107 was given to all patients with HLA-A1/A2 as the antigens are designed to respond only in those patients and all non-HLA A1/A2 were given tumor lysate vaccine from their own tumors. HLA type is not known to have any bias towards survival (just like various blood types don’t have any bias towards cancer survival).
There was a statistically significant increase in overall survival from 20.2 months for tumor lysate to 38.4 months for ICT-107 even with such a small number of patients. Median PFS also significantly increased from 9.3 months for tumor lysate vaccine to 16.9 months for ICT-107.
Although, this was not a prospective study design and not randomized, this further validates the clinical data and shows that patient selection hasn’t played a key role here.
Even the Phase I design was not perfect; the data are very impressive to me. The most important thing is that we all agree that the Phase II trial is really a well-designed study to demonstrate efficacy by comparing it to a control group that gets a dummy vaccine.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
ICT-107 is an add-on therapy to the soc in both Phase I and Phase II trials. The major point is to see the difference between the SOC and SOC+ICT-107. Therefore, I am not very much concerned about the patient status. Of course, Phase II is a much better controlled trial.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
I believe management will try their best to be successful because it will benefit the company as well as its shareholders.
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
The Next 3 Big Things For ImmunoCellular Therapeutics [View article]
http://seekingalpha.co...
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
I think ONTY is a very decent company. Pipeline is very strong, very diversified, and has many middle to late stage candidates. Pipeline targets huge cancer markets such as NSCLC, Brain cancer, head & neck cancer.
Balance is also very strong. Cash burn is not an issue right now for the Company.
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
We may get some clue when the data safety monitoring board finishes an interim analysis for safety and futility after 70 events.