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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.
Just to add what many don't realize is that Biosante still has global rights to Bio-t-gel and Elestrin outside of the US. Smart move on their part, let the market for these products develop once they are popular they can obtain a greater royalty percentage for the rest of the world. Or use the money from royalties to help launch their global marketing efforts.
I can't tell you where it will be but I can tell you that BPAX was floating around the $2.50 and the average analyst 1 yr target price was $6 prior to the December drop. Libigel was presumed dead by many.
Since then:
Bio-t-Gel strongly appears to be heading for PDUFA approval
But make no mistake Libigel the big prize (was never dead)and with the 2012 patent applications regarding Libigel outlining a 70% reduction in cardiovascular disease in addition to subset analysis of efficacy data, plus a 90% chance of not only meeting but exceeding safety trials in addition to the possibility that Libigel improves cognitive functioning. It looks like Libigel could very well be a much bigger product then originally realized. Female Viagra which will not only will help you live longer but can help delay the onset of alzhiemers. Even if the Female Viagra can arguably be matched by a placebo the health benefits are not there with the placebo.
Long term there is the cancer research.
In the end make your own assessment. But earlier I suggested that the any realistic buyout should be in the $1 billion ($9 to $10 per share) and that would have to come out before the safety results are made public later this summer . Afterwards the price will only go up. Those who have truly have researched BPAX know what I am talking about.
Good info anyone wanting to learn more about BPAX cancer program
Follow the link within the post and read the threads
Slight correction - the Pancreatic Cancer trial is Phase II being led by Aduro Biotech with a completion date of October 2014.
How does one tell Emperor $heff "he has no clothes" without being banished?
The real question should be "Why was BPAX downs so much in the first place?" It still has a long way to go before it reaches it's FAIR market value. Even with pending lawsuit which will eventually get thrown out (no insider dumped their shares before the stock price crash of 80% and some were buying stock up to 1 month earlier).
I am pretty confident you won't have to wait 4 years to take a good profit. But if the company is not bought out you may want to keep your toe in the water with some of your shares for the Cancer vaccine ride.
Aduro's phase II trials of GVAX pancreas has an estimated completion date October 2014. The Chronic Myeloid Leukemia (CML) and Acute Myeloid Leukemia (AML) — Phase II trials complete they are waiting a partner to go to Phase III. They have also move forward on melenoma and breast cancer through the out-licensing through John Hopkins
GVAX out-license.
I have seen a number of companies with a market cap in excess of $500 million with one drug in Phase III trial an nothing to speak of in the pipeline.
Take a look at Dendreon Market Cap $2.11 billion. If GVAX is successful. It could be lights out for Dendreon as Gvax can be mass produced. Which means a higher profit margin while providing a product at a lower price.
Biosante could be a very interesting company in 4 to 6 years. The pipeline is shaping up like a set of dominoes. When one gets across the finish line the others will probably follow one after the other just like falling dominoes.
While you are waiting for the cancer vaccines to move forward there is The Pill Plus to keep us entertained.
From a project management standpoint, this company is well set up for continuous movement and progress.
Long term, if BPAX is not bought out and healthy revenue has started to accumulate, I wouldn't be surprised if they went after a marketing and distribution company to take the company to the next level. They will have a very good R&D program, an extremely good patent portfolio (ranked in the top 15 in 2010.) They will have experience in taking 3-4 drugs through FDA approval. The marketing arm will allow them to maximize profits and really lift the value of the company.
Any company seriously looking at buying BPAX must factor in that Libigel will get approved. Simes stated that he wanted to bring Libigel across the finish line to maximize the value of the product before selling the rights to the product. That is why so much money has been spent on the safety trials. Coincidentally the consensus is that there is a 90% chance of meeting or exceeding the safety targets. The company has funding to last through next year. If a company waits until after the safety results are released the price will definitely go up.
In order for the company to seriously entertain a buyout it should be in the $1 billion range. $9 - $10 per share. They have to make it appealing to sell early. Remember, back in November 2011 many analysts had a 1 yr target of $6 on BPAX and a strong buy. Libigel has always been about safety first. Even if the sexual satisfaction is in doubt. The testosterone deficiency is real and there is no other approved product on the market for women. Libigel was more then successful in delivering testosterone to pre-menopausal levels while the placebo did not move the needle. The cardiovascular and possible cognitive benefits can only enhance it's value.
In addition
The buying company will obtain:
Global distribution rights to Elestrin outside the US.
Global distribution right to Bio-t-gel outside the US
The future potential winfall from the Pill Plus
Biolook
And all the cancer vaccines. which could be advanced at a quicker rate with proper funding.
With BPAX's deep pipeline a company with deep pockets should see the return on their investment rather quickly.
Thanks for the support. We've all been new at this at one point.
Firstly do your own due diligence. No one will take of your interests better then yourself.
Libigel (aka Female Viagra - Company announced that Libigel got equalled by the placebo effect on the sexual effectiveness)The market treated it like this was the only product Biosante had in mid December. Read the threads to see why Libigel is still in play and not dead. Including benefits of a 70% decreased risk of cardiovascular disease for those using Libigel.
Bio-t-gel PDUFA Feb 14 Teva responsible for regulatory process amd marketing.
I have provided you with some additional information to speed up your research.
Look at the Biosante website lots of info, read up on the products and the pipeline
The look at the following links it will help speed up your research.
Collection of significant information
Cancer Vaccines
Read the threads.
Now you should have a good understanding of BPAX
With this knowledge you may want to assess its true value.
Assessing Bpax value
Exercise in determining a true market value for BPAX
This is primarily for new BPAX followers to assist them in doing their own due diligence.
First go to the Biosante website, get to know BPAX look at the products and read about their development ensure you look at the cancer vaccine link it will let you know where the company sit in relation to cancer research.
Now that you have an understanding of BPAX go see how it compares in its present valuation to where you believe it should be.
Biotechnology and drugs
This is a list of 310 Biotech an Drug companies
Find Biosante (today at $81.41 million , page 11)
If Biosante is not on the page,sort the list of 310 companies by market cap
Now click on the company names above Biosante.
This will bring you to the stock price quote and chart page, on the right hand side of the page lower down you will see the link to the company that you are comparing BPAX to. Now look at that company's product and pipeline. See how they compare.
Repeat this process up the list and you will see how truly undervalued BPAX really is.
Personally I was looking for companies with two FDA approved drugs and a cancer research program similar to that of BPAX.
I was researching on the assumption that Bio-t-gel gets approved.
I am presently at companies with a Market Cap of $350 million and I am still climbing the list. (Note I excluded generic drug approval from the comparison)
Remember once the pps is above $1, it is all about market cap
Hope this helps in making a decision
That means the 30 day waiting period is over. Kopp sold Dec, 31st, filed Feb. 2nd, should be interesting if Kopp's wants back in on Monday.
Let's see Kopp sells all, while Vanguard adds 2,876,786 shares. Who do you think employs the best advisors?
What if someone bought small number of shares at $1.01 at the close. How many shares would it take to restart the de-list clock?
Does the de-listing crap go away? It would be just another form of stock manipulation, which BPAX has obviously been experiencing.
Well said. I could never decipher the science but the Prof makes it easy to digest. Until they publish a Clinical Trial for Dummies. We need people like the Professer. You know the MM's have their own Nutsyprofesser.
I am not certain as to the similarities other then they both use a trans-dermal gel. Male testosterone medication is usually at a higher dose then what is required for women. Therefore Libigel is required for a safe method to restore post menopausal women testosterone levels. Even if the Female Viagra may not be in play as anticipated.
There is still an unmet need for female testosterone restoration where Libigel is the only company in a position to address this need because of the extensive safety trials. The success of the safety trials to date estimate a 90% chance of approval based on safety.
Biosante may be able to save the Female Viagra image with subset data analysis or another more restricted trial. Their meeting with the FDA will no doubt dictate what avenue they will pursue.
Similar product are already FDA approved. So safety has already been proven. From my understanding BIO-T-Gel is a trans-dermal application where gel is absorbed and delivered throughout the body, similar to an injection. Other products include topical treatments which have been known to transfer some testosterone to the sexual partner. Not good for a partner who has normal testosterone levels. Other methods include injection so with Bio-t-Gel no more needles are required.
It was positive news for those familiar with the company. For those unfamiliar we must let them do their due diligence before they jump on board. I still believe the MM are still manipulating this stock. Until the MMs are done accumulating this manipulation will continue. Some may be attributed to the shorts but the consistency of preventing a run over the last 10 days leads leads me to believe this is the MM. If this was professional sports they could be cited for collusion. I think Nutsyprofessor indicated that we are within 6 million shares of the 49 million shares that were dumped right after Dec 14th.
I wonder if the company did a 1 for 5 reverse split if that would end some of the manipulation. BPAX would be trading at $3.25 It would end the misguided delisting issue once and for good. It won't stop MMs from manipulating, as they are smart enough to look at the Market Cap of a company and not the PPS to see if there is value.
Why BPAX cannot walk away from Libigel.
Interesting article about a presentation given in November 2011 by Professor Susan Davis at international meetings reporting on the research undertaken within the Women's Health Research Program regarding the effectiveness and safety of testosterone therapy for women
Professor Susan Davis is also heading the cognitive study of Libigel in Australia.
Testosterone in women
Female Viagra or not, a safe delivery method for Testosterone is required.
By Q3 2012 Libigel extended trial and subset analysis of Bloom Trials results should be out and Bio-T-gel PDUFA Feb 14th would have passed. If these are all positive. Expect approx. $6 PPS, more if serious buyout rumors surface. Sept. to mid Dec. 2011, BPAX had a 1 year target price of $6.
Funny how the analysts have an average 1 year target price of $2.85 (338% ROI) yet most still have BPAX as a Hold, not Buy or Strong Buy. Could it be the Institutions are not done accumulating? I bet when they are done accumulating you will see the strong buy recommendations fly off the shelf.
Two CV Patent Applications regarding Libigel (January 2012)
Methods for treating sexual dysfunction while decreasing cardiovascular risk
Abstract
Methods for treating female sexual dysfunction are provided. In particular, methods for treating a woman having HSDD by administering to the woman a therapeutically effective amount of an androgen, whereby the therapeutically effective amount of the androgen is administered in a manner that results in a reduction in expected number of cardiovascular events in the woman are provided.
Methods for decreasing cardiovascular risk in postmenopausal women
Abstract
Methods for decreasing the risk of cardiovascular events in postmenopausal women having a high risk for a cardiovascular event are provided. In particular, methods for decreasing the risk of cardiovascular events in postmenopausal woman at high risk for cardiovascular events by administering to the woman a therapeutically effective amount of an androgen, whereby administering the androgen decreases the risk of cardiovascular events in the woman compared to untreated postmenopausal woman at high risk for cardiovascular events are provided.
While examining other biotech companies it appears that when looking at cancer research, all you need is a phase 3 trial to get a +$300 million market cap bump. A number of companies concentrating on cancer research have only one product in phase 3 with no product ever getting FDA approval yet their market cap is above $300 million.
Biosante presently has completed two phase two trials with promising results
Chronic Myeloid Leukemia (CML)
Acute Myeloid Leukemia (AML)
Due to the cost of phase III trials, Biosante must wait to move these forward or find a partner to take then to the next level.
Aduro is presently conducting a new Phase II trial with the GVAX Pancreas vaccine.
Share price popping possibilities include:
Bio-T-Gel PDUFA Feb 14
Libigel Gel Extention trial results
Subset data analysis from the Bloom trials, remember it appears they did not equally distribute the placebo and Libigel between those with HSDD and those without, if so, there is a 75% chance that the efficacy on the intended population (those with HSDD) was under-reported.
Announcement Libigel's Cardiovascular benefit.
Announcement of Phase III trials for the Pill Plus.
Finding a partner for the phase III cancer trials.
Libigel safety trial results.
It looks like a load gun just waiting for someone to pull the trigger.
I agree. One piece of positive news and you have lost your low entry point