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Nutsy, Jeff, the following excerpt supports Nutsy's claim that the FDA does have flexibility in deciding on whether to accept a single trial. I don't know if this guidance extends to unmet needs. Note: there is a claim that it is non-binding.
The evidence critical for supporting drug approval, including the preferred number of clinical trials, is discussed in the guidance for industry FDA Approval of New Cancer Treatment Uses for marketed Drug and Biological Products and in the FDA Modernization Act of 1997. In most cases, the FDA recommends at least two adequate and well-controlled clinical trials. In certain cases, evidence from a single trial can be sufficient (e.g., in cases in which a single multicenter study provides highly reliable and statistically strong evidence of an important clinical benefit (Is the CV Benefit good enough to qualify?), such as an effect on survival, and in which confirmation of the result in a second trial would be practically or ethically impossible). For drugs approved for treatment of patients with a specific stage of a particular malignancy, evidence from one trial may be sufficient to support an efficacy supplement for treatment of a different stage of the same cancer
Guidance
I believe the FDA recognizes the placebo effect has become a problem when many drugs today may not get approved if they had to compete with the placebo used today. Hence the non-inferiority trials against existing drugs.
I think the FDA and Biosante should use Libigel as the litmus test to apply the enhanced Benefit-Risk assessment in Regulatory Decision Making which is in the PDUFA Reauthorizing Goals and Procedures FISCAL YEARS 2013 THROUGH 2017
Benefit-Risk Assessment
I also previously found info from a Benefit-Risk Workshop
If the workshop recommendations were applied it would negate the placebo effect.
Jeff,unless I am missing something the parts you hi-lighted in bold are consistent with the December 14th release by Biosante
December 14 release
I consider pumping mostly what you see on Yahoo price predictions with no supportive evidence or reasoning same for buyouts rumors. What you are seeing here is consultative analysis,a big difference.
You shouldn't stop learning even on weekends. If investors were restricted to only selling and buying shares, no options, no put etc... Either you own the stock or you don't. Much of the discussions which you call pumping would not be needed.
True it is mostly in a positive fashion. But even you have to admit there is something going on. What has happened to Biosante's share price is not normnal and does not pass the smell test.
There is a good group on this board and I for one have learned a lot from the discussions.
Another reason I have faith in the company is:
Louis W. Sullivan, M.D. (Chairman of the Board)
Biosante's Bio on Sullivan
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. Since retiring from the Bush Administration, Dr. Sullivan has been associated with the Morehouse School of Medicine in Atlanta, Georgia. Currently, he serves as President Emeritus and he previously served as President and Dean of the School from 1981 to 1985 and as President from 1985 to 1989 and from 1993 to 2002.
Dr. Sullivan serves on the board of directors of Henry Schein Inc., United Therapeutics Corporation and Emergent BioSolutions Inc. Dr. Sullivan also serves as chairman of the National Health Museum in Atlanta, Georgia and as chairman of the Sullivan Alliance to Increase Diversity in the Health Profession.
Forbes Bio on Sullivan
77 Years Old
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. Since retiring from the Bush Administration, Dr. Sullivan has been associated with the Morehouse School of Medicine in Atlanta, Georgia. Currently, he serves as President Emeritus and he previously served as President and Dean of the School from 1981 to 1985 and as President from 1985 to 1989 and from 1993 to 2002. Dr. Sullivan serves on the board of directors of Henry Schein Inc., United Therapeutics Corporation and Emergent BioSolutions Inc. Dr. Sullivan also serves as chairman of the National Health Museum in Atlanta, Georgia and as chairman of the Sullivan Alliance to Increase Diversity in the Health Profession. Dr. Sullivan previously served on the boards of directors of Inhibitex, Inc., 3M Corp., Bristol-Myers Squibb Company, Cigna Corporation and Georgia Pacific Corp.
Forbes Bio
This person is very well connected and supports quality.
That is exactly what I have been wondering. Ardea went for $1.26 Billion on the back of one product a gout treatment (Phase III trial) and a liver cancer treatment in phase II trials.
I agree, and it might not take long, as it leads right into the Jefferies 2012 Global Healthcare Conference June 4-7, New York city, where Biosante is suppose to be presenting.
Jeff, I just looked at the opportunities page again. I am most intrigued by what is missing.
There is no mention of oncology.
Now look at the first sentence on the About us page of Biosante's website
"BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology"
About Us
Seems very odd. Unless, they have a partner already speaking for the entire Cancer Program.
Thanks for the attachment.
Jeff, Nutsy according to the 10K Tang is not suppose to purchase more shares until after the ASM, Could this be interpreted as not increase his position? Thereby, allowing Tang to sell and reacquire the shares at a lower price. There appears to be a lot of creative wording in the agreement, as Jeff had previously stated. If Tang could argue that he understood the essence of the agreement to mean position in the company, with no more voting share accumulation, he may be able to counter that reacquiring of shares to reestablish his net position at the time of the agreement was acceptable.
The agreement may be able to prevent the acquisition of additional voting shares, but I see an opening for reacquiring shares.
Personally I got in at $2.13 and I am down to $0.72. I'd be down even further if I could of foreseen the manipulation.
I still see $2.13 as a very good bargain if you can hold on for more then a year.
Good luck to whatever you decide. Bottom line is you have to be comfortable with what you own.
I agree with the trust assessment. That is why I did not think he would force himself on the Board but may eventually work his way there.
They appear comfortable with Tang owning up to 20% of BPAX for a reason, but obviously in the case of a merger it, could be an impediment so he agrees to get back to under 10% if a merger occurs.
Hopefully, you get back in before it pops. If not, I hope our paths cross again.
Take care.
Jeff, you asked earlier why would Biosante post that they are looking for partners, since they are well connected in the industry and shouldn't need to. This could be a way of seeing countries like China, India and Russia have to offer. It could also elevate the going price to partner (i.e higher royalties, milestone paymnents).
duplicate error
Correction forgot to add the word Billion to AstraZeneca's net revenue, it should read $10 billion.
Saw a post on yahoo which makes sense. It could be related to the Biotech Index semi-annual rebalancing.
Index Shuffle
If he goal is to get on the Board, Tang won't be selling he will be accumulating through stop loss triggers. Going one step further could he help orchestrate a partnership with AstraZeneca?
AstraZeneca is hurting in the new product front and has a number of patents approaching expiration. On the other hand they posted almost $10 in net revenue last year.
Just another possible scenario.
Could this be part of Tangs master plan to eventually get on Biosante's Board of Directors?
After all he is on AP Pharma's Board.
AP Pharma Board
He is also on Ardea Bioscience Board which is presently being acquired by AstraZeneca for $1.26 Billion
Ardea Board
I can't remember what was there before either.
Good work.
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.