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Just realized that there is a phase 2b to the Parkinson Disease CRE 120 trials still ongoing. Therefore if this is the target of their acquisition Phase III may not start until 2013 or 2014
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
You are most likely right they don't care about the shares movement by message board posters. I would be looking for info that may come from disgruntled employees or whistle blowers. They have to vent and venting can materialize anywhere including message boards.
But maybe, I expect them to be more thorough then they are.
Valuable information can be found almost anywhere. I agree analysts and institutions most likely won't post here unless they are following a lead. But, if they are good at what they do they will look at all leads including message boards. A junior analyst has to start somewhere. True you may have to filter through a lot of crap to find the nugget. You can use the lead and then seek information to corroborate it.
All the research I have done on this company. Leads me to believe that there is a reason for everything they do or don't do. The company has some very intelligent and methodical people. In time we will see how smart they were. I believe they would have loved to tell us everything will be okay and explain why, but it may have been premature and could have negatively impacted future plans or run afoul of the FDA. They must play by their rules
If you take a good look at diversity of the BPAX Pipeline and the timing of the milestone movements of the various products it ensures there is always one or more product at the forefront. It looks like it was designed by a very good project manager (not left to chance.)
They realize they must restore share value, but without derailing their long term vision.
Not so Nutsy Professer, as i understand it Jeff from Yahoo board has been a long time GVAX proponent. Obviously I concur with his assessment. I believe the coverage from the Lancet could attract more well healed and well informed investors which should put some upward pressure on the share price before Libigel info comes out.
That is correct but can't help but notice the coincidence that Biosante is presenting at 10:30 am on Feb 14th.
I have added the Ceregene link look at pipeline, board of directors
Ceregene
News article explaining that in 2001 Ceregene was formed as a subsidiary of Cell Genesys
Cell Genesys Subsidiary
I have already provided the link to the phase 2 trial.
Once again this purely speculation.
They had already stated publicly that hey were shopping for a product or a company. As for you conversation. I wasn't their. I am sure they have script read off. Any media or PR department has a script and they must stay on message.
I believe the call will be pointless and the information will be released when BioSante Pharmaceuticals, Inc. Presents at Biotechnology Industry Organization's 14th Annual BIO CEO & Investor Conference, Feb-14-2012 10:30 AM. I believe they want to time it with the announcement of the Bio-t-gel. This way if approved(which may have already happened) I don't know if there is lag time between the formal approval and when the PDUFA makes their announcement. I had read that usually the company gets a letter of approval for their timely disclosure before the FDA makes the formal announcement(don't know if this is factual).
Ceregene (privately owned company) was once part of Cell Genesys which Biosante bought out in 2009 and by process of elimination the product that makes the most sense to purchase would be Ceregene's CRE 120 used to combat Parkinson Disease. It has completed Phase 2 trials and would be ready to go straight to phase III possibly with the support of the Michael J. Fox foundation.
Note: Simes sits on Ceregene's board of directors.
CRE 120 trial
Realize that this is just conjecture. The announcement of Bio-t-Gel approval followed by the phase 3 trial for Parkinson would give a big pop.
Now on Sale Biosante up to 75 % of Retail Market Price. Hurry these prices won`t last!
The following will show you companies selling for far above BPAX with a fraction their pipeline diversity or proven ability to get FDA approval.
Sangamo Bioscience - has 1 Phase II and two Phase I/II clinical Market Cap = $222.48 mllion
Amicus Therapeutics - has 1 phase III and 1 phase II trials Market Cap = $232.18 million
Corcept Therapeutics - 1 awaiting PUDFA, one phase II trial Market Cap= $232.48 million
Cadence pharmaceuticals - has one approved drug and nothing in the pipeline that I can see. Market Cap= $256.37 million
Geron Corp. has 6 phase II trials. Market Cap =$262.29 million
Arena Pharmaceuticals has 1 product FDA issued CRL October 2010, 1 phase II Market Cap =$283.29 million
Navidea Biopharmaceuticals has one product just approved , and 2 phase III trials Market cap = $ 304.35 million
MannKind Corp. has 1 phase III trial Market Cap = $306.02 million
Chelsea therapeutics has 1 phase III trial and 4 phase II trials market cap = $308.62 million
Anthera pharmaceuticals has 1 phase III and 2 phase II trials Market Cap $318.26 million
Progenics Pharmaceuticals has 1 approved product, 1 FDA approval, 1 phase III trial and 1 phase II trial Market Cap = $321.08 million
Aegerion Pharmaceuticals – Has 1 phase III trial Market cap = $349.94 million
Oncotheryion has 1 phase III and 4 phase II trials Market Cap = $358.53 million
Ziopharm oncology 5 phase II trials Market Cap = $361.42 million
Oncolytics has 1 phase III trial and 9 phase II trials of Market Cap = $365.45 million (very similar to the BPAX cancer program)
Raptor Pharmaceuticals has 1 phase III and 3 phase II trials Market Cap = $372.16 million
Now look at Biosante
Biosante = Has 1 approved product , 1PUDFA decision this week, I in late stage phase 3 trials , 1 product in stage 2/3 trials, 3 phase 2 cancer trials awaiting money or partners to go to Phase 3 trials, Through the university a phase 2 trial being conducted in conjunction with the partner’s product. And 4 designated orphan drugs. In addition 16 % stake a company with 1 phase 2 cancer trial and a 19 % stake in another company with 2 phase 2 trials. Market Cap = $93.62 million
Now what do you think BPAX is worth?
Yes and no. The bad press doesn't attract the uneducated investor. What probably has the biggest impact on share value not being realized is that many do not understand how good the BPAX cancer program really is. Libigel, Bio-t-Gel Elestrin, The Pill Plus are small potatoes to the real prize.
What I find interesting is the Price/Earnings ratio where BPAX is above the industry average by 272%. I attribute that to many companies doing cancer research having large expenses. If you look at what the Market Cap is on most companies doing strictly cancer research, they are trading at a much greater market value then BPAX. These companies for the most part have no diversity and are relying on one or two products in clinical trials, many in phase II. This proves to me that Cancer vaccine has not been priced into the market(yet).
This is where many are underestimating the business savy of BPAX Management. By getting 4 products Orphan Drug designation it opened the door to research opportunities at a lesser cost. This enhanced the work with John Hopkins University who is helping find partners and attracted additional funding. They have out-licenced to the university who will partner with other companies who want to try the GVAX in combination with one of their drugs. This is newest way to treat cancers. There are 17 cancer products presently in the BPAX pipeline using this process I see this number growing very quickly. It is like preparing a meal you have to try out different ingredients to see what works. BPAX will never have the cure for cancer treatment by itself. But no one else will either. But BPAX is poised to be an ingredient in many cancer cures. I believe the Lancet will be doing many more articles on GVAX as it is tried in different combinations. When these treatments are approved GVAX has a 30 % royalty established through the agreement with the university.
Bottom line, BPAX is able to move forward cancer research and eventually share in the spoils, while minimizing their expenses. This in addition to the fact that GVAX can be mass produced will translate into larger profits over the other cancer treatment products once approvals start coming in.
A few items to help you assess BPAX true value.
Price/ Earnings Ratio
BPAX Price/ Earnings Ratio = -1.54
Industry Average Price/ Earnings Ratio = -4.20
BPAX has a Price/ Earnings Ratio that is 272.73 % above industry average.
Earnings Growth
BPAX 2011 Earnings growth = 16.43%
Industry Average 2011 Earnings growth = 9.20%
BPAX has a 2011 Earnings growth that is 78.57 % above industry average
Market Cap
The average Market Cap of the industry = $3.108 Billion
BPAX Market Cap = $93 million
BPAX Market Cap is at 3,342 % below the industry average
The Lancet is the world's leading general medical journal and specialty journals in Oncology, Neurology and Infectious Diseases. Has increased it's coverage of GVAX quite a bit. This should help give the cancer program street credibility and attract more longs.
GVAX
I agree, if Greece stabilizes then it bodes well for all markets. However, Greece has been anything but predictable. Then there is Spain.
And the only one who can honestly say they did their due diligence on BPAX. Mind you if a person is covering many stocks it may be difficult to do the digging so they skim the top for information and make their assessment.
Slight correction Libigel did get submitted for approval it is still in the trials. They will be meeting with the FDA for guidance on how to proceed.
It is for hypogonadism for which there are 5 million + sufferers (viagra etc... is not the competition and wouldn't work). There are a few competitors but they either involve needles or topical gels - topical gels transfer testosterone to you female partner. Bio-t-gel doesn't. Where did you get $1 million from?
I prefer more accurate math Bio-t-gel has much greater revenue projections then you estimate. Common $1 million that workout $10 - $15 for Teva. I have linked a more realistic projection.
Bio-t-gel
And this only for the US. Biosante still owns the rights to the rest of the world. Teva is in over 60 countries. I see another agreement with Teva for the rest of the world down the road once Bio-t-gel marketing in the US is established.
Saw it before, but thanks and good for the newbies to see.
The dollar value you are referring is the Market cap = number of shares x Stock quote = Share price mean nothing other then under a buck for de-listing. Market Cap tells you what the company is assessed at on that day. Share price was around $0.53 cents on the previous post. It was liken to a dated document from January. (97 million was today's Market cap)
Comparisons don't matter for day traders because they have a short time frame High risk - high rewards philosophy. But for the uneducated trader and a potential long investor- comparisons do matter.
Even a trader may pause if they actually looked at the stock they had in their hands at this low price and did a little due diligence.
Since Biosante is not starving for cash anyone wanting to buy the company would probably have to fork over $1 Billion = $9 / share and that is before Libigel is approve. They have to go on the assumption it will get approved if they wait after approval the price will be higher.
Too big a gamble for the shorts to ride it out. Safety is not an issue since there are other similar products on the market. What benefit is there? Transdermal (AIS) technology is more advanced no needles, no topical gel which can be absorbed by the partner. This is why there is such a strong belief it will get approved. Playing the devil's advocate. There may be a slight pull back if not approved but BPAX is still grossly undervalued that the price will continue to climb, it just might take a little longer.
If you are concerned look at what other company's are trading at and look at their pipeline. I put it together for those new to BPAX and to show the fire the shorts are playing with.
BPAX Value Assessment
I thinks this may come out of the Feb 14th. We will probably get an up to date Market Data Overview presentation, similar to the Jan 2011 on their website. I have been checking to see if they have updated it (not yet). Biosante has a busy month I expect little nuggets at each event as more info comes available.
BioSante Pharmaceuticals, Inc. Presents at Biotechnology Industry Organization's 14th Annual BIO CEO & Investor Conference, Feb-14-2012 10:30 AM
BioSante Pharmaceuticals, Inc. Presents at Citi Global Healthcare Conference 2012, Feb-27-2012 03:30 PM
BioSante Pharmaceuticals, Inc. Presents at 24th Annual OC Growth Stock Conference, Mar-11-2012
BioSante Pharmaceuticals, Inc. expected to report Fiscal Year 2011 results on March 15, 2012. This event was calculated by Capital IQ (Created on July 28, 2011).
I forgot to add that most of these companies have never taken a product through FDA approval.
18 reasons why BPAX should be trading between $3 to $4 even without Bio-t-gel or Libigel
I have made this easy for anyone who wants to compare product pipelines I have also included the company's Market Cap. If Bio-t-Gel is approved and the information below sinks in you are looking at a $4 to $5 share price on February 14th.
Biosante Product Pipeline $98.47 million
Overview
Cancer Vaccine
Other companies with Annual revenue less then $10. million and a negative Net Annual Income
Novavax $162.11 million
Cell Therapeutics $212. million
Keryx $234.38 million
Amicus Therapeutics $234.96 million
Corcept $259.43 million
Cadence pharma $268.46 million
YM bioscience $278.94 million
Chelsea Therapeutics $308.00 million
MannKind $316.53 million
Anthera $323.17 million
Progenics $337.29 million
Oncothyreon $341.89 million
Aegerion $356.93 million
Ziopharm $364.16 milliom
Oncolytics Biotech $366.89 million
Raptor Pharma $370.72 million
Avanir $401.38 million
Map Pharma $472.40 million
Is this new info on the Biosante Cancer webpage?
Pancreatic Cancer — Results of Phase II
Phase II clinical study that showed BioSante's Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. A new multicenter clinical study is planned to begin this year.
In the study, titled, "A Lethally Irradiated Allogeneic GM-CSF-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma: A Phase II Trial of Safety, Efficacy, and Immune Activation," published in the February 2011 issue of Annals of Surgery, the primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses. The median disease-free survival of patients was 17.3 months (95% CI, 14.6–22.8) with median survival of 24.8 months (95% CI, 21.2–31.6). The administration of immunotherapy was well tolerated. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that "an immunotherapy approach integrated with chemoradiation is safe and effective for resected pancreas cancer."
The 60 patient Phase II study was conducted by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland. The research was funded by the National Institutes of Health and other foundations. BioSante's Pancreas Cancer Vaccine is made from allogeneic pancreatic cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth.
Cancer program alive and kicking new patent application posted today.
New Cancer Vaccine Patent Application
This all supports my earlier analysis that any buyout should at least be in the $Billion range.
Buyout Value
Mo-John I added another link to the post with more Biosante info.
I may be wrong but they may be letting Bio-t-gel have it's moment.
I expect Teva and Biosante will have a media conference or something when approved then you will see this info officially released along with their next step. Unless something bigger is in the works.
AF is either very lazy in his research or a stock manipulator. Either way he has no credibility with the educated investor. GVAX hold was lifted. True there were concern when Cell Genesys was conducting Phase III cancer trials but they were using it as a cure and were treating patient late stage cancer. They were to far gone to get their own immune system restarted the trial was stopped and GVAX use was put on hold.
However those who survived ended up living or are living much longer.with this new info, GVAX was reformulated and is now used in combination with Chemotherapy or other types of therapy and is used to boost the immune system to fight the cancer. If a person goes though chemotherapy there is often residual cancer cell that survived. If left untreated the cancer can grow again. Gvax acts like a mop by boosting the immune system to the point where these cells are mopped up and destroyed.
HIV Aids ran into a similar problem it wasn't until they started combining medications to treat it that they found success. This is the new way to treat cancer and much success is being achieved.
I have attached a link to more Biosante cancer info.
Cancer program
More info on BPAX I had fun assessing the value which gave me a visual as to who under rate BPAX was
More Info
It looks like the Libigel extension study is complete
Extension study
In addition to today's media release on the stock for debt swap
This transaction will extend BioSante's cash runway and is important as we continue to analyze the best path forward for LibiGel®,
I believe they wanted money to further explore the subset data analysis, as the Nutsyprofessor expected.
I wouldn't discount the revenue value of Bio-t-Gel. Immediate revenue may not be great but the existing agreement is only for the United States. Teva currently employs approximately 47,000 people in over 60 countries and reached $16.1 billion in net sales in 2010. The global potential with a company like Teva is great.
While waiting for Libigel developments, don't be surprised if they announce the start of Phase III trials of the Pill Plus by Pantarhei Bioscience.
They could release their decision this morning.
I found this post Recent Example of early PDUFA decisions
INCY got FDA approval yesterday yet their PDUFA was for Dec. 3,so 17 days earlier than expected.
If you use that example into consideration,Anturol's PDUFA of Dec 8th would instead be decided next week on Nov. 21,just 4 days from now!
Note: I have not validated the information but then again I am not risking getting caught on the outside looking in.
For those selling with the intention of profit taking and getting back in on a dip. Please realize the FDA has made approval decisions on numerous drugs weeks' before the actual PDUFA date, especially when there has been an extension. There may be no dip better then the price you bought it at before you sold.
Good one
Too bad one of these market manipulators couldn't be charged with conspiracy to commit murder. You just need to make an example of one. It would make things really interesting and bring balance back to investing.
Maybe an ambulance chaser will take this idea and run with it as a wrongful death class action suit.
Nothing like fighting fire with fire.
Imagine the headlines "Major Institution subject of Class Action Wrongful Death suit." I bet they develop ethics real quick by then.
Reality check time, I can only hope that the market manipulators including bloggers and institutions alike never need the cure these companies are trying to deliver. The intentional delay of the progress of these companies is costing lives. Particularly companies doing cancer research like Biosante. Time is a luxury many cancer patients do not have.
We can all live without the iPad or the iPhone. Many can't live without the cure.
I am not certain on the exact royalties figure I have read as high as 10% and as low as 7%. As for milestone, the company website states milestone payments upon commercialization but I believe one of the filings I read listed payments at both approval and marketing. The number $10 Million at approval rings a bell. But it may be announced before I find it again.
Gary I am glad you turned a profit. Honestly, I looked at the similar type of scenario accept I held my position over $2 for a couple of months. When the stock dropped 80% I averaged down playing the bounce and the PDUFA. When the bounce didn't happen. I wondered if I made a mistake. It was the best investment thing that ever happened to me. I ended up digging through the posts the previous company headlines the websites and then the Nutsyprofessor and their like minded people on Yahoo board along with the information on this board including looking up clinical trial information, patent information and partnership info and their trials. Now I had a good understanding of Biosante and the product pipeline.
What clinched it for me was when I queried the 310 Drug and Biotech companies on Google finance and sorted them by market cap. I then looked up every company with a greater market cap then Biosante and went to their website. I looked at how their products and pipeline,the financial and potential earnings all compared to Biosante. This was an eye opener. They didn't compare, not even come close to comparing until the upper $300 million market cap. I couldn't wait until the first trading day of the new year. Trust me anyone, who simply does a comparative product and pipeline analysis as I did will not be selling their shares at these cheap prices to turn a quick buck.