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Thanks Jeff good pickup by Jadite.
I have hi-lighted info that may indicate where this position is headed. It leads me to believe they have a partner, for a Libigel NDA submission and the trial work for the CV benefits and maybe even trial work for GVAX.
New position is as follows
CLINICAL RESEARCH ASSISTANT - L3
SUMMARY:
This position´s primary function is to support the multiple activities required for the successful initiation and completion of clinical trials.
REPORTS TO: Vice President, Clinical Development
Joanne Zborowski (Vice President, Clinical Development)
Ms. Zborowski has served as our Vice President of Clinical Development since 2010. Prior to this Ms. Zborowski served as Director of Clinical Development since 2007 and has been with BioSante since 2002.
Before joining our company, Ms. Zborowski began her pharmaceutical industry career with Abbott Laboratories. From 1990 to 1998, she held positions in Medical Affairs and the Pharmaceutical Products Division where she worked on neuroscience, oncology and cardiovascular indications. Ms. Zborowski held similar consulting positions from 1999-2002.In light of this posting
Joshuri, the average pps that Management and the Board have bough at is almost twice your average pps. Their goal is to maximize the return not only for the shareholder but themselves as well. Do yourself a favor. Google biotech buyout, takeover, merger for the last year. Look at the value of the deals, and the pipeline of the companies. I take it that you have been keeping up to date on the info Nutsy, Jeff, and those on this board have provided in relation to pipeline. Then compare the Biosante's pipeline to the ones that have been sold. For example Inhibitex sold for $2.5 billion for a couple of drugs in phase II trials.
Inhibitex Pipeline
Biosante has a better more advanced and diversified pipeline. Even if Biosante were sold for $2.5 billion that would be over $20 /share. Personally if Libigel moves forward on an NDA submission I would vote down a $20 offer, as I believe the company could get a much better deal or with their pipeline they could go it alone.
Those who are patient will be rewarded.
I for one would be willing to pay a flat fee for every transaction (no exemption). The fee would go to beef up the SEC to support investigations to bring integrity to the markets. Those 100 block shares and computer generated trading that bring down the price would become costly. It would stop this nonsense rather quickly.
Biosante knows how to best use the CV data. Look at Dr. Snabes resume. This wont be the first heart related medication he helped get to market.
Michael C. Snabes, M.D., Ph.D. (Senior Vice President, Medical Affairs)
Before serving as Senior Vice President, Medical Affairs, Dr. Snabes was BioSante's Vice President, Clinical Development from 2008 to 2010 and a medical consultant to BioSante on clinical and regulatory matters since 2005. Dr. Snabes has been a board certified reproductive endocrinologist and holds a Ph.D. in physiology and reproductive endocrinology.
Before joining our company, Dr. Snabes was an Associate Professor in the Section of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology at The University of Chicago Pritzker School of Medicine. From 2003 to 2004, Dr. Snabes served as Medical Advisor in Clinical Research and Development in Inflammation, Arthritis, and Pain at Pfizer, Inc. and from 1999-2003 in the same position at Pharmacia, Inc. where he worked on the successful development of the COX-2 inhibitors, Celebrex and Bextra. From 1997 to 1999, Dr. Snabes served as Associate Director in Clinical Research in Women's Health at Searle/Monsanto. Dr. Snabes is an elected Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology. Dr. Snabes is the author of more than 150 publications and abstracts.
Food for thought. If a Libigel NDA submission occurs sometime in the fall, what impact would positive cognitive results from the study in Australia have leading up to the PDUFA date. This study should be completed by November 2012.
Cognitive Study
Here is the Board If you meant Simes, yes he is on the board. It has a good cross section of financing, medical research and application and governmental experience. The Honorable Louis W. Sullivan, M.D. has been our Chairman of the Board since 1998 and has been a director of our company since its formation. Dr. Sullivan served as Secretary of Health and Human Services in the cabinet of President George H.W. Bush from 1989 to 1993
Board of Directors
If something was wrong with the company, they would have to take appropriate action. Their silence throughout the last couple of months speaks volumes, it indicates management has the support of the Board. Not to mention many on the board have a lot more to lose financially then pretty well all of us.
I can't help but think there is a much bigger plan afoot. There are very intelligent people in Management and on the Board of Directors. They have a master plan which as a group we have tried to piece together. Obviously we are still missing a couple of pieces to this puzzle (i.e., partnering, buyout,etc...).
I have no doubt that when it all unfolds, one or more of us will look back and say how did I miss that. Personally I think in the end the puzzle will concentrate on the CV reduction and possibly GVAX.
If voted down, they would need a plan "B" to present to Nasdaq on how get the price above $1, otherwise risk losing the 180 day extension.
You are right on the assertion that it should go back up but no one can honestly predict the price as it is so heavily manipulated. Personally I am not concerned about share price at the moment, as I intend on keeping this company as part for my portfolio for years to come (unless it sells). This may be killing day traders but investors have a much longer horizon and those with additional cash see this as an opportunity that does not come by often.
Biosante is presenting at Jeffries in a little over 2 weeks, last year they had a number of announcements just prior to the same conference. I expect we will get a number of announcements this year as well.
Thanks Jeff, I had looked up Cell Genesys history and the work at John Hopkins, particularly Dr. Jaffee and knew that Provenge had an easier path to approval. I also learned that CEGE spawned several companies including Abgenix which later sold for around $2.2 Billion (CEGE obviously kept its star asset - GVAX). I will look further into the individual trials. I have an idea of the value of the company. Your info may have just raised the target price I had in mind.
ASCO 2012 Abstracts for GVAX
ASCO
The safety results will have to be accompanied by the PR that they have an NDA path for a Libigel (HSDD, Testosterone, CV, etc...) for a large boost. We all know the value of the safety data, but many investors might not make the connection, otherwise the price would not be sitting where it is. Safety data alone may produce a smaller boost but not the big bang.
The manipulation in order to accumulate shares will persist as long as people keep selling. I noticed a number of post on yahoo about potential buyouts at $2-$4 (patents included) and a number responded they would sell.
Do you think this is testing the waters to see where the next major shakedown might take place allowing for further accumulation? This would capture those who are in it only to get back to even from the drop in December. Once this play is completed then the big boosts will occur bringing the price in line with its true value. Obviously there will be tests along the climb.
Nice breakdown.
Welcome aboard Jeff, I appreciate all your post on Yahoo.
Interesting theory. In order for Tang to reach 19.99 %, it would appear that much of the manipulation would be at his hands. Seeing that trading volumes have been low. It has made the price control easier to accomplish.
Thanks DG you are correct. A bit tired I guess.
The gel filling machine from Aptar Pharma can be used for libigel, and other products,
Key Features:
Several actuator options ensuring a wide range of dose volumes
Exact dispensing of products from liquid to viscous formulation
Airless pump supports airless or atmospheric filling
High barrier protection for oxygen and light sensitive products
More than 90% restitution rate
Supports 360° use for convenient application
Unique experience in airless filling technology
Machine
I wonder if Elestrin which is presently manufactured by DPT LABORATORIES LTD will be manufactured by Biosante in the future?
Elestrin
Since it cost nothing to play:
From a business perspective you would like to do it earlier allowing for greater share consolidation (10:1) freeing up more shares for later distribution, if required, without jumping through additional regulatory hurdles.
For the investor the opposite as the share total dilution would be less (2:1 or 3:1)
Since Management and the Board of Directors collectively own 2,647,541 shares(not including outstanding options, I expect a balancing act, where a 5:1 ratio will suit their needs.
This stuff might work on yahoo but we have a very well educated board here. So you are going to have to do lot better then that.
Pharmasset - Phase II trial completed about to start Phase III for hepatitus nothing else to speak of, no revenue sells for over $11 Billion
Inhibitex $ 2.5 Billion same thing no revenue.
These companies were bought for their science and patents, there are others
Now Biosante was rated in the top 20 biotechs for the quality of their science and patents by Patent Board and tops in research intensity in February.
Big pharma is in trouble with expiring patents and would love to gobble up a company like Biosante. With Gvax being nominated as one of the top 5 vaccines this year and the discovery that low dose testosterone reduces the risk of CV events by 71%, You are going to have to do much better then that.
I would be highly surprised if the company has not been fielding offers. But management and their board of Directors no the value of the company.
Note: If you are paid to post on this board. Well they can say goodbye to that money.
This is a sign of semi-bad news (laying off to preserve cash)
Jan. 31st, 2012 Corporate update
In order to conserve cash, a reduction of 21 full-time equivalents of employees and contractors has been implemented, representing 25 percent of BioSante's headcount. In addition, if the safety study is halted, the monthly burn rate will decline to approximately $1 million per month, pending other corporate product development and activities.
Corporate update
This is a sign of good news and it is yet to be released but posted on Biosante career web page May 11th, 2012. They appear less worried about preserving cash. Now ask yourself, why?
Biosante is looking at hiring for the following positions
05/11/2012 CAPA Manager
05/11/2012 Director, Quality Assurance
BPAX Jobs
Don't get me wrong I am not saying I want a reverse split. It is strictly a tool in their war chest. However to support expansion it is a tool that has worked in the past. The other option is debt financing which has its issues and can be very restrictive. With what is going in Europe right now and the US debt who can predict the future of interest rates. From business perspective issuing more shares to support expansion may be the most logical and safest choice.
Where it works is when the company has potential to grow. I think BPAX has a lot of growth potential and can one day become a major player based on the quality of their science.
Remember nothing that has happened with this company or stock has been typical.
How it can work
Market reaction to the PR of a NDA submission and what is happening with the CV data will dictate whether a reverse split will even be needed.
You are correct, I am police officer and I have been looking for clues in relation to Biosante since December. I thought the name (Joe Friday's tag line on Dragnet) give it away. I see you can spot clues as well by picking up on the terms investigate and case.
That is why I try to support everything with a link, old habit, I am use to corroborating my evidence.
I read a book called Wikinomics by Don Tapscott on mass collaboration, ironically he was right about its power. That is what the constructive groups on iHub and Yahoo have been doing with Biosante by sharing their information. It is a powerful tool to counter market manipulation by harnessing the collective knowledge of the group. Almost like investigative investing which goes well beyond due diligence.
It has been fun.
Your welcome, oddly this is the first time I have ever investigated/ researched a stock to this extent. It is like trying to solve a case. I have learned a lot over the last couple of months which will serve me well as a hobby when I retire.
R3D is right they don't need a reason to play with the stock. But on the topic of R/S, Biosante needs to show NASDAQ that they have a plan to get back above $1. They obviously are not going to prematurely divulge the info they have that would appease NASDAQ, so approval from the shareholders will be enough to grant them 180 days grace (should they need it) There is a lot of info the company has yet to release some of which I and many others have uncovered and posted in the past.
A reasonable persons could easily deduce from the CV pantents, Commercial Production patents and statements from management believing they found the reason for the elevated placebo, the purchase of a $800,000+ gel filling machine and the advertising for a Director of Quality Assurance and a CAPA Manager. That Biosante is moving forward on the idea of submitting an NDA for Libigel (HSSD? CV- Hypertension and Dyslipidemia? Testosterone Replacement? Maybe all of them?) and has every intention of manufacturing it.
If Biosante finds a suitable partner, the upfront signing bonus can finance a manufacturing facility. However if the offers don't make sense, Biosante will most likely go it alone. A R/S in order to elevate the share price prior to issuing more shares to finance the manufacturing and maybe even a marketing program makes total sense and will draw a number of institutional investors negating the impact of share dilution and maximizing ROI in the long run.
In relation to Diabetes Mellitus more work will be required but data on at least 608 test subjects is a very good starting point to formulate a phase III or a phase III b trial.
In 2009, the diabetes treatment market generated worldwide sales of over $25 billion, with strong growth from the previous year. The incidence and prevalence of diabetes mellitus are on the rise worldwide, in line with lifestyle changes and ageing populations. In particular, the increasing prevalence of diabetes is closely linked with that of obesity, creating significant market opportunities in developed nations and some developing countries. The World Health Organization estimates the number of diabetics to exceed 350 million by 2030. Governments and other healthcare providers around the world are investing heavily in prevention and treatment of this serious - but controllable - disorder.
As our new report – World Diabetes Market Analysis 2010-2025 – shows, the diabetes market is one of the most important sectors in the pharmaceutical industry. All segments of the diabetes therapy market have been expanding, but which will grow fastest in years to come? What are the main therapeutic and commercial trends to watch?
Could the post menopausal women section end up migrating towards testosterone restoration (Libigel)?
Diabetes Market
The Global Anti-Hypertension Market In 2009 was estimated to be $36.9 Billion
Hypertension Market
Note: the following is an excerpt of the above article.
"Due to expected patent expiry of blockbusters such as Diovan, Cozaar and Avapro, the market is forecast to decline at a CAGR of -5.5% between 2009 and 2016."
US Market.
Due to the increasing availability of generic antihypertensive agents in the coming decade, the hypertension drug market is projected to decline from $26 billion in 2009 to $23 billion in 2019 in the U.S. France, Germany, Italy, Spain, United Kingdom, and Japan, according to a report by Decision Resources, a pharmaceutical and health care research firm.
Novartis's Diovan/Tareg is expected to suffer the greatest decline; its sales are projected to decrease more than $1 billion in 2013, following the entry of generic versions of the drug. By 2019, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, calcium channel blockers, and diuretics will all be subject to generic competition, the report concludes.
US Hypertension
Biosante is well positioned to help a company such as Novartis who are losing their star patents.
In 2009 the Dyslipidemia Market was approximately $33 billion of which approx. $18 Billion was in the US. In 2009 the primary form of treatment for Dyslipidemia is statins (approx $29 B Globally & $15 B in US). The percentage of non-statin treatment has been increasing at the expense of statins especially in the US.
Dyslipidemia Market
Something interesting from the Bliss trial
Hypertension - number of patients in the trial = 1962
Dyslipidemia - number of patients in the trail = 1870
This was out of 2899 enrolled patients by April 2011. Seem to me there may be enough evidence (especially if their groups had a CV risk reduction of approx. 71%) to get this group in the NDA application.
From what I have read phase 3 trials usually look for 1000 - 3000 patients.
More work may be needed for the following groups.
Diabetes mellitus - number of patients in the trial =608
Current smoker - number of patients in the trial = 569
Bliss trial
As I understand it the cognition study stopped recruiting only because they reached the required number. They do not have results yet to match to placebo this is a study or phase 1 at best at the present moment. The Bloom trial had the uncharacteristic placebo effect. The study in Australia is to address another unmet need Alzheimers. But you are correct that the cognition study in Australia will have to watch for that.
If Biosante isolates the cause of the high placebo effect and gets HSDD back on track. Libigel with it's HSSD along with the other possible uses including: Testosterone HRT, CV reducing benefits and cognition improvement, might very well become the medical equivalent of duct tape.
Libigel Cognitive study has stopped recruiting, link dated April 26th, 2012. We should hear something early in the New Year.
Testosterone and Cognition Study (LIBIGEL STUDY)
Recruitment is CLOSED
Principal researcher:
Prof Susan Davis
Researchers have been investigating whether restoring testosterone levels in older women to those of younger women will improve brain function and ultimately protect against dementia. They recently found that a small dose of testosterone administered each day for 6 months was associated with improved visual and verbal learning and memory in a small group of postmenopausal women.
You may be eligible to participate if you are:
55-70 years old
Postmenopausal
Have no significant health problems
Not using hormone replacement therapy or antidepressants
The study will be run over 6 months and there are 4 visits to the study centre at The Alfred Centre, located in Prahran, Melbourne. At each visit, cognition testing will be performed using a computer. There is no need for computer literacy to participate in the study.
Study info
Take a serious look at the Biotech companies with the same market cap as Biosante. Look at their cashflow, pipeline and walk your way up to until you find a company with similar cash flow and pipeline. It is the price of the stock that is ridiculous not your perceived pumping. What you see as pumping, I see as proving that the company is grossly undervalued due to extreme manipulation and uncovering what has yet to be revealed. Connecting the dots so to say.
It is no different then you price predictions.
I agree on getting ready, my assumption that they met the FDA is based more on the 90 day time frame in the January PR and FDA guidelines on meetings. Nutsy also had a good point, that they may want the minutes of the meeting in their hands prior to any type of PR on the matter. Personally I believe they are timing everything to benefit from the Jeffries Conference first week of June. There will be a flood of PR possible from now through the Shareholder's Meeting up to the Conference.
I agree that we should always exercise some caution. But The FDA has guidelines and time lines to meet companies upon their request. If memory serves me,it is 60 days from request.I believe I read that the FDA would like a 90% compliance on these target dates. If I digested what I read correctly and Biosante wasn't delayed in the request to meet the FDA they probably have met.
I may be wrong, but Biosante hires quality personnel, I can't see them posting jobs at this level until after they had met with the FDA and realizing what path they have to follow. If there is a lengthy delay, why hire now?
I agree, that is why I have more faith in the investigative posters, on the message boards, those making statements that can be corroborated.
Obviously Roth Capital is wasting their money on paying analysts. A fact checker scouring the yahoo and iHub boards would do a much better job of predicting a 1 year target price. Apparently Roth Capital cuts BioSante Pharmaceuticals price target $0.90 to $0.75.
CNBC
Or are they part of the group conspiring to keep the price artificially low? Either way I wouldn't invest with them as their due diligence appears to be very limited.
Regardless of what happens, I would put the collaborative efforts of those on this board and the Yahoo board against any analyst. Numbers only tell you part of the story. That is where Nutsy, Jeff , Jadite and others from the Yahoo board along with the constructive contributors from this board have been able to see the story beyond the numbers.
I agree that the future looks bright. I expect additional hiring to come as it relates to production. These hires will set it up properly and ensure continuous improvement and quality control but they will need staff to run it.
I believe it goes beyond correcting the placebo and preventing future placebo effects. It goes toward manufacturing and production. Remember they bought a filling machine and have filed a patent application for commercial production.
You are right though on the implication that they have identified the cause of the placebo effect.
Part of the NDA approval process includes inspection of the manufacturing process. This, I believe is the primary reasons for the hiring.
The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The following resources provide summaries on NDA content, format, and classification, plus the NDA review process:
NDA Application
Proof biosante met with FDA and they liked what they heard.
Why else would Biosante be looking for following positions (posted today):
Director, Quality Assurance
SUMMARY:
This position has overall responsibility for the Quality Assurance (QA) function. Provides strategic direction to the organization to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance with applicable regulations.
REPORTS TO: President & CEO
CAPA MANAGER
SUMMARY:
This position has overall responsibility for the management and implementation of the Corrective and Preventive Action (CAPA) Process to ensure compliance with applicable regulatory requirements.
REPORTS TO: Director, Quality Assurance
Biosante Careers
Interesting slide show on the original set up for the Bloom trial
Bloom
I noticed that it originally had stratification for the following;
- No estrogen
- Oral estrogen
- Non oral, systemic estrogen
This apparently was moved over to the Bliss Trial
Primary efficacy outcome
Inventory of Sexual Events and Desire (ISED)
ISED Validation
To my understanding Biosante was being used as guinea pigs for the ISED in efforts to have patients more active in determining efficacy. Designed to reduce but not eliminate the subjectivity of the testing method. Not certain this method has ever been tested on another drug seeking approval,
In the key secondary efficacy out come measure you will notice Subject's Global Assessment Question, this is used in the Bliss trial. I don't know if this was part of the Bloom trial also or if they separated this as well.
It appears that the way the SPA was set up left for a number of permutations to pull data to create plausible pathway to NDA submission (ie, Efficacy from Bliss trial with supportive confirmatory evidence of elevated testosterone in the Bliss trail)
Bliss Trial
I don't know, BMY did pay $2.5 Billion for Inhibitex and offered $3.5 Billion for Amylin. BMY Yevoy was used in combination with GVAX Prostate not pancreas. So who knows?
Another GVAX study has started. A pilot study but obviously showing the versatility of GVAX and the combination therapy approach of the future.
Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
Study