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Bang on, Jeff and Pete, I agree 100%. And Jeff, thanks for all your GVAX - CEGE info. I found it interesting that CEGE actually acquired GVAX when they bought Somatix Therapy Corporation in 1997.
That is a good one. I must be hitting some nerves.
Pumpers and bashers don't support their claims that would take too much work. True I have spent a lot of time on this stock. But I am not chasing a whack of stocks. You will see I haven't posted anywhere else. That is because this is the one stock (not POS) that is most undervalued and abused by MM and shorting.
I am using this as a trial run for a hobby to take into retirement. Basically I look for a grossly undervalued stock and investigate the crap out of the company, its employees, its activities and its history and any other connections I can find.
If successful, the research techniques I have developed will allow for an earlier retirement and something that will be shared with fellow retirees. Basically there will be many more of us.
Sorry if that upsets you. Now as Jeff said go tell your boss.
Smallinvestor, presently no real investment analyst or firms are really covering or writing about Biosante since the December fall. Even the Teva Bio-t-gel has stalled coverage due to the agreement.
Confirmation that they will be seeking NDA approval for Libigel, a product for which they will have the market for themselves will increase the coverage. More institutional investors will be drawn to the coverage and this will increase price. Once Biosante is on their radar they will see that there is more to Biosante then just Libigel.
Expect a quick rise when shorts are forced to cover, followed by a a slight drop (profit taking) then a long steady growth and this chapter should be behind us.
The big drop had large volume 48 million of 110 million shares,most of the activity since March has involved less then 3% of outstanding shares. Once real money looking for large profits and volume comes in we will see consistent share price appreciation.
Seventh Libigel Safety Data Review release Oct 11, 2011
Eight Libigel Safety Data Review release February 9, 2012
If they only need the same period of time as was used between the 7th and 8th safety data reviews, we could see the 9th Safety Data Review release tomorrow.
JohnNewen - Chimp Fatrs! LOL
So you follow the charts, then you must be familiar with Thomas Bulkowski. According to Bulklowski only 56 % of stocks lose ground 3 months post split. That means 44% are successful.
His warning depends if the company did it solely to prevent de-listing. However other factors can make it a good move.
The chart won't predict a short squeeze on very good news or a buyout offer.
So bottom line the reverse split is not the end of the world.
Thomas Bulkowski
Good post Zeppo, just adds more perspective.
A little perspective.
Simes has been the CEO of two companies which were later successfully sold Unimed and Gynex, before taking the reigns of Biosante. The company has survived 9/11 the 2008 financial crisis. They are on the cusp of a major break through (good news willing) that may revolutionize a number treatments, HSSD, Tetsoterone replacement, Hypertension, Dyslipidemia, Diabetes Mellitus and Alzhiemer's.
For all this to happen they have to satisfy the FDA. If it does take a little longer, so be it, it will be well worth the wait.
The move to merge with Cell Genesys may eventually to be seen as one of the most astute business moves in history. Time will only tell.
Remember they all own more shares than most of us. So they may not keep shareholders informed. But I am certain there are reasons they have let things play out the way they have and in time we shall learn the rest of the story.
Jeff, Abstracts from GVAX Lung Cancer trials in China. Were you aware of Cell Genesys and their work in China. With estimates of approximately 350 million smokers in China, I can see why they would be working on treatments for lung cancer.
Abstracts
Abstract explore granulocyte - macrophage colony-stimulating factor (by granulocyte-macrophage Colony stimulating factor, the proportion of GM-CSF) gene-modified tumor cell vaccine before and after treatment of DC in peripheral blood of patients with lung cancer two different subsets (DC1, DC2), treatment before and after the ratio of change in correlation with clinicopathological features and survival. Methods: 74 patients who received GM-CSF gene-modified tumor cell vaccine (GM-CSF, modified tumor the cell vaccine, the combination of GVAX) treatment in patients with lung cancer, the proportion of peripheral blood DC and lymphocyte subsets in flow cytometry before and after treatment analysis before and after treatment changes in the proportion of DC, DC proportion of pre-treatment serum markers and immune cells before and after treatment, the relationship between DC ratio on survival of patients with lung cancer before and after treatment. Results: after receiving GVAX vaccine in treatment of peripheral blood DC1 and DC2 proportion of no significant change (PDC1 = 0.786, bit 15-0 PDC2 = 0.779); neural enolase (NSE) levels higher than normal levels of NSE group of DC subsets in the group; DC2 proportion of Treg before treatment after treatment, a negative correlation; DC2 proportion of early stage lung cancer patients after treatment, lower than the average survival time was higher than the mean survival time was significantly prolonged. Conclusion: DC2 proportion after treatment as early in patients with GVAX vaccine efficacy and prognosis of immune parameters and their influence on the prognosis may be related to the proportion of patients with peripheral blood Treg certain.
Abstract :Dendritic cells (DC) can be divided into two subgroups based on the markers and functions: myeloid DC (DC1) and plasmacytoid DC (DC2). This study evaluated the clinical significance of the proportion of the DC subgroups in the peripheral blood of lung cancer patients before and after GVAX vaccineation. Methods: Seventy-four patients with lung cancer were enrolled in the study. Flow cytometry was used to detect the proportion of DCs and lymphocyte subgroups before and after GVAX vaccination. The correlation of DCs with serum markers and immune cells was tested. The Kaplan-Meier was used to analyze the correlations between DCs and survival of patients. Results: There was no significant change in the proportion of DCs after GVAX vaccination. The proportion of DCs was higher in the group with elevated levels of neuron-specific enolase (NSE) than in normal controls. A negative correlation was observed between the proportion of DC2 post-GVAX vaccination and the proportion of Treg pre-GVAX vaccination. For patients with early lung cancer, those with a proportion of DC2 below the mean value after vaccination had better overall survival compared with those with a proportion of DC2 greater than the mean value. Conclusion: A low proportion of DC2 after GVAX vaccination is a predictor of better prognosis for patients who received GVAX vaccination. DC2 proportion post-GVAX vaccination may have a correlation with the proportion of Treg in the peripheral blood pre-GVAX vaccination.
Cell Genesys in China
If Teva royalty revenues start to roll in. It will also prolong the run.
I believe the efficacy results of the Bliss safety trial will be sufficient. Plus it will have measured a greater audience enhancing its accuracy.
3656 Enrolled in Bliss Trial vs 1172 enrolled in two Bloom trials.
This along with the rest of the previously clinically accepted data should make for a good argument.
Suezia or is it Sues ya or Sues You? Just like the rest of the fear mongering fictitious law suits.
Pete, keep contributing, everybody has their own area expertise, it is by all the contributions from different areas that provide a much bigger picture. It is the best way to counter market manipulation.
I am certain the professor would agree, but he has used up quite a few free post today. I for one would like him to have a few left in case breaking info is learned.
Professor, could it be that naked shorting caused this delay? Since they are starting from scratch there only 20.14 million shares to distribute. I wonder if some brokerage firms got caught? If so, then those that have settled had the least or no naked shares.
Given that Biosante purchased a gel machine, I think the manufacturing will stay in house, JMHO.
It looks like Bayer is slightly behind Biosante and Pantarhei as they recently completed the following phase II trial.
Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido.
Trial
Pantarhie is looking to partner for phase III. Logical choice may be Bayer. Who will want to use concomitants when a single drug will do?
Yet, another potential future use for Libigel. Note that Susan R Davis who is involved in this study, is also heading the Cognitive study in Australia.
Future use
Is Biosante Abbott's farm team? Yet another position that moved from Biosante to Abbott.
Linda Andrews
Jeff, Biosante the movie you mentioned earlier, may have an international audience. There may be more GVAX trials and treatments then Simes presented in the conference today. China appears to be working with the GVAX and it looks like the abstract relates to a phase II Lung Cancer trial.
According to the Chinese Journal of Clinical Oncology 2012 No. 39, 9
74 patients with lung cancer GVAX treatment of peripheral blood dendritic cells and its clinical significance
by
Cao fir Renbao Zhu Zhang Xinwei Han Ying Zhang Wei Hung Hui Zhen-Zhen Qi Ying Yang XuenaRen Xiu Bao
Note: Biosante's website and today's slide presentation does not mention Lung Cancer.
Abstract
Professor, you may very well be right on Biosante intending to go it alone for Libigel, It may have been their intention all along. In 2007 they hired Joy Thomas away from Baxter Health to fill the job of VP Corporate Development. Where she was Sr Director of Business Development. Once Libigel is a go, I expect her to show up on the Management webpage.
Hiring
Ms. Thomas comes to BioSante after 13 years with Baxter Healthcare Corporation where she was most recently Senior Director, Global Strategy & Business Development for its Renal Division. Earlier she was Director, Strategic Marketing and Planning for its Medication Delivery Division. Ms. Thomas holds a Bachelor of Science degree in Finance and Russian from the University of Illinois, and a Master of Business Administration in International Business and Finance from the University of Chicago.
Joy Thomas linkedin
If they intended on staying a R&D company and out licence their products, I believe Thomas' skills and experience are wasted.
I believe, they could also run a phase IIIb trial for HSDD efficacy trial while commencing on the Testosterone NDA submission and update the NDA submission prior to decision for approval. It would a hybrid of the two examples you gave and maybe even allow them to keep on track with the 2013 Q2 - Q3 approval date.
Like they did with Aduro and the Hussman foundation.
Professor, I read your Abbott - Biosante connections Yahoo post
Just to add another twist into the plot.
Bristol-Myers Squibb and its partner, Abbott, presented an update of Phase 2 results on the investigational cancer immunotherapy elotuzumab.
BMS Abbott partnership
Thanks iricos and welcome to the board.
Jeff, saw it on JHU website.
Good to see you and the Professor followed up on other employee backgrounds (i.e., Abbbott)on Yahoo. I had to step out for the evening.
Thanks
Jeff, if I am not mistaken the Dr Oz show was from January 2011. Though, Ron's story is a great success.
I expected them to release something already as they did last year going into the Jeffries conference. Flip a coin your chances are just as good.
Another interesting fact, Abbott has already acquired one company in which Simes was formerly the CEO.
From 1994 to 1997, Mr. Simes was President, Chief Executive Officer and a Director of Unimed Pharmaceuticals, Inc., (currently a wholly owned subsidiary of Abbott Laboratories) a company with a product focus on infectious diseases, AIDS, endocrinology and oncology.
May mean nothing, but you never know. Abbott did sue Teva over Bio-t-gel patent infringement.
The Web administrator is subtle in giving Libigel the green light or the Libigel is environmentally friendly. Take your pick.
Medi, was she there to spy on Biosante or help Biosante. If Abbott wants their info she may be there to a spy, if Abbott wants to partner she may be there to help.
You saw that, too. Spy or mentor? The timing is what gets me.
The recent posting for SAFETY SPECIALIST - Contractor
REPORTS TO: Manager, Pharmacovigilance
Interstingly Alfreda Boreika
Sr. Clinical Safety Analyst at Abbott Laboratories
Was the Clinical Trial Safety Manager, Pharmacovigilance
BioSante Pharmaceuticals, Inc.
October 2010 – May 2012 (1 year 8 months)
Boreika
With everything going on at Biosante, the timing of the move is peculiar. Maybe just a coincidence.
Jeff, as Gene testing (aka DNA based testing) becomes more prevalent, I can see the GVAX type vaccines increasing in use.
Gene testing
Thanks Professor, I guess I have more dots to connect.
I agree with senderos, regardless of what has happened I believe the company will do what is best for shareholders. Remember the management and the Board are shareholders too. Traders are on their own.
Professor, on Jan 31 Biosante released the following statement
The LibiGel Phase III safety study continues and will continue during further analysis of the LibiGel efficacy data and until a final strategic decision has been made. It is BioSante's objective to meet with the FDA to determine the best path forward, and to make a decision whether to continue the LibiGel safety study within the next 90 days
Now many, myself included, took that to mean they had yet to make the request to meet the FDA. Within 90 days could mean day 1 or day 89.
What was preventing Biosante from requesting the meeting once the top line results were revealed. Their discussion could have revolved around the 505(2)(b) NDA submission which you have work hard at proving.
If they then met prior to the February 20th conference in Isreal
The following statement on the agenda takes on much more credibility.
A CLEAR PATHWAY TO APPROVAL FOR LIBIGEL® TREATMENT OF POSTMENOPAUSAL WOMEN WITH HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
Your thoughts?
To Professor and the board, your right, I apologize and I will refrain from speculating in the future.
JohnNewen, Google scholar, this is usually peer reviewed, then I used the key info in regular Google. It often brings up different hits. Google ranking system can make it easy to miss important nuggets of information.
Possibly, but I think Biosante is now continuing as normal and are set up to make an NDA run, in the event that the shareholders turn down the buyout offer.
Once again this is still just a theory. Time will tell if I am right.
Jeff,you bring up some good points, but I am still leaning towards a buyout. If it was a partnership, Biosante's share price would have no bearing on the partner or the deal. In order to get biggest return for investors they played along. Teva was pulling the strings. "Play nice or the deal is off."
I am wondering if the final condition was the passing of he final safety hurdle.
As for raising money to go alone they could have approached shareholder for a R/S or an increase in total shares for the purpose of distribution to finance operations until revenues catch up. With all their cards on the table.
Remember what I have been suggesting is still circumstantial, simply a theory based on facts I uncovered.
I guess we will find out in the next little while.
If my theory is correct we know they have a HSDD and testosterone markets to themselves, most likely hypetension and Dyslipidemia ready to go for NDA, they buy back their Bio-t-Gel royalty. Get Global rights to Bio-t-gel and Elestrin (outside US)which is approved in Isreal and may have already been purchased from Valeant since we haven't heard boo about the product.
And at least one phase 3 cancer trial ready to start
My guess is somewhere north of $8 Billion (based on the offers have been going around and rejected)