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The benefit of Biosante deal to partner with John Hopkins University and the Sidney Kimmel Comprehensive Cancer Center. At no additional cost to Biosante.
Identification of Annexin A2 (ANXA2) as a Pancreatic Cancer Antigen
In addition it is not the same type of product.
An oral enteric formulation acting on the central nervous system (CNS) with therapeutic characteristics that benefit sufferers of sexual health disorders. It is intended as a treatment for HSDD both as a standalone and as an adjunct to testosterone therapy for the disorder.
It does nothing for testosterone replenishment or CV benefits which has been identified by Libigel. And a along way off.
Follow up on MPR12001 (Yahoo Board)and SEC complaint
I told you I had filed with the SEC going through a friend of mine about the malipulation and fraud being committed on BPAX. The individuals and hedge funds involved are in a lot of trouble. Besides not having shares to cover their shorts they have commited outright lies about the company. This will take time, but I am assured I am not the only one who has been taken noticed of by the SEC about BPAX. He could not provide me with whom it is or how many but it is assured this is being investigated. My case is HO::~00195451~::HO
in case you too want to file. Mention this case ID.
Thanks for the referral.
Found this article in the American Heart Journal
A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder
Safety trial
I don't know if the results are starting get out but there seems a definitely increase in interest. The article lays out the process and rational in easy to understand language.
I found this statement in the conclusion interesting. Don't know if it refers to future product development,expansion of the target audience or for general consumption by other researchers.
Conclusions
The BLISS study is an important and novel study for establishing the safety of LibiGel testosterone therapy in postmenopausal women with HSDD. The operational principals of this study may be applicable to conducting safety studies for other drugs in other populations with low event rates. The study has been ongoing since 2008 and has been actively enrolling and randomizing participants. The BLISS study is designed to document the efficacy and safety of LibiGel for treatment of HSDD, a common condition for which there is no FDA-approved pharmaceutical treatment in women.
This is probably true with most industries but less so in the biotech industry. In the biotech industry they also rise on their potential for future revenue. I counted 38 companies trading above Biosantes' market cap all with less annual revenue than Biosante.
One being Pharmasset with a market cap of $10.36 Billion which was bought by Gilead.
In what world does a company like Sangamo get a market cap of $279.68 Million and Biosante has to fight for a Market Cap of $86.50 Million?
Sangamo Pipeline
There are many more Sangamo's out there.
I'll take my chances with Biosante, thank you very much.
You are correct it is only an application at this point. But it is the information within the application about CV efficacy which should make us sit up and take notice. At least 70% risk reduction in CV events
As for the patent application this an area where they excel, based on the Patent Board's Scorecard ratings for Biosante the last couple of years, they are well versed in the process of obtaining patents and very capable of obtaining this one.
Top 15 2010
I would love to be a fly on the wall at the FDA meetings.
CV Stats
Patent indicates at least a 70% risk reduction.
More than 42 million women currently living with or at risk for heart disease in the United States.
35.3% of deaths in American women over the age of 20, or more than 432,000, are caused by cardiovascular disease each year
You know a large percentage of these women are post menopausal.
Info on CV
Do the math. HSDD is small potatoes compared to this market.
I saw that.
Biosante has very educated people in their camp. They must have a reason for doing it.
Possibilities include:
Susbset analysis of Bloom trials showed something promising and meetings with FDA are working on another more restrictive trial singling out the target audience to prove efficacy.
FDA is requesting something to have Testosterone delivery and CV reduction included or the primary purpose of Libigel.
Decision to take Libigel to NDA application rather then look to have a partner take over.
To fund a phase 3 cancer trial.
To fund the Pill Plus phase III trials
Prepare the company for a sale
I am certain there are other possibilities and that it will all make sense when the information is released.
I agree, the activity leading to June could be explosive. I anticipate favorable guidance from the FDA on Libigel, Excellent safety results on Libigel and the announcement that Phase III clinical trials for the Pill Plus will have commenced.
Each announcement will give a big boost to share price. Any other news in the meantime (ie, Phase III cancer trial has commenced) will be an added bonus.
Too much upside not to wait it out. If I am wrong it is only money you can always earn more. If right it is a life style change.
I agree. When I did comparative shopping of the pipelines, I couldn't believe that I was lucky enough to have this stock on my radar. So invested a hole lot more.
We must not overlook in-licensing a product as well. Simes stated that was a possibility as well. Either way he wants it to be a share price mover.
For a day trader you are probably right as the gamble due to the extreme manipulation. For the patient investor I have to disagree.
Any in doubt simply look at Biosante' market cap and pipeline read about it and understand it. Then start looking at the competitor's pipelines and stop when you come close to a company with a similar diversified pipeline. That is your fair market value. You will notice that you have to climb a long way to find a company with a similarly diversified pipeline.
The probability of going to $2 in 2 weeks is far greater then going to $0.50 and staying for 3 months.
I have added a post by NutsyProfessor which must be considered before writing off BPAX.
Here's the real scope on LibiGel bashers:
There are millions of OFF-LABEL testosterone prescriptions currently being given by doctors to address FSD!!! The FDA wants to solve this problem!!!
LibiGel will be the first of it's kind for this treatment that will not only complete a Safety Trail under an FDA SPA but, as it turns out, LibiGel is actually REDUCING the number of CV events vs placebo.
The FDA will aprove LibiGel to treat FSD for the following reasons REGARDLESS of efficacy:
1) LibiGel will have completed a safety trial under an FDA SPA.
2) LibiGel will address the off-label usage issue.
3) LibiGel REDUCES CV events.
This is a win-win-win for all: the FDA, Doctor's and patients.
Like it or not LibiGel will proceed, an NDA will be submitted to the FDA, and it will be approved.
In addition, BPAX still owns the full rights to Bio-t-Gel and Elestrin. There is a world outside the US and the growth potential is huge.
By partnering they have found a way to move their diverse pipeline forward. Instead of putting their eggs in one basket and going it alone they have chosen to spread out the risk. In time this model will create a very good revenue stream as more products get approved. This allows Biosante to concentrate on their business strength R&D.
If you are shorting this stock any piece of positive news could derail your plans.
- Libigel FDA meeting results,
- Elestrin and Bio-t-gel worldwide distribution deals at a greater
royalty rate
- Partnering for a Phase III cancer trial or Pill plus trial
- Even the sale of the company or one of its products.
- The realization of the rest of the investment community as to
how undervalued the stock is.
Just keeping it real. By doing my research, I suggest others do the same.
Expect new developments to come out when BioSante Pharmaceuticals, Inc. Presents at Citi Global Healthcare Conference 2012, Feb-27-2012.
Then when BioSante Pharmaceuticals, Inc. Presents at 24th Annual OC Growth Stock Conference, Mar-13-2012 12:30 PM. Wouldn't it be nice if they had met with the FDA and had some good news regarding direction.
So was BPAX until they started walking it down the following morning. Hopefully they now have new toy to play with.
Shortly after BPAX released the efficacy results in December, I believe analysts such as Leerink Swann (AF's source of info) pegged 1 year target at $0.70 . The 1 year target is an estimate that the stock will reach that price sometime in the next year. Now, let me see how far off was their projection, it has already reached $1.17 during regular trading hours approximately 2 months into the year. A proper analysis will at least be close.
Now are you really concerned about what Leerink Swann guesses for a valuation.
On the other hand other more serious analyst peg the 1 year target at $3.00. Clarity on the Libigel meetings with FDA and if they go as expected consider the following:
Libigel elevated the number of satisfying sexual events (subjective)
Libigel performed better then Intrinsa by a wide margin.(objective)
Testoterone levels were raised to pre-menopausal levels (objective)
(Testosterone provide a list of other health benefits including reducing oteoporosis)
Reduction of cardiovascular events for at risk women. (Objective)
The placebo did far better then the placebo used by Intrinsa, had they used the same placebo Libigel would be cruising towards approval. As result the Placebo matched the increase in satisfying sexual events. Two issues arise 1) why did the Placebo do so well and 2)This is the only subjective test. From a purely scientific standpoint it is the weakest part of the trials for overall reliability.
How many doctor would prescribe placebo over Libigel?
Remember, before the efficacy results were released Most analyst had including Leerwink Swann had a 1 year target of $6 some as high as $8 for BPAX and the CV Benefit had not been factored into their estimates.
I expect the target price to jump above $6 (how much I don't know) if the FDA meetings go favorably.
I believe Analysts such as Leerink Swann (AF's source of info) pegged 1 year target at $0.70 . The 1 year target is an estimate that the stock will reach that price sometime in the next year. Now, let me see how far off was their projection, it has already reached $1.17 during regular trading hours approximately 2 months into the year. A proper analysis will at least be close.
Now are you really concerned about what Leerink Swann guesses for a valuation.
According to the PR dated Jan 31 2012, 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. Hopefully we will hear something before April 31st.
How true.
I posted the following comment in response to their using AF's article.
Forbes pick up AF article
Forbes is a respected institution, for that reason you may wish to consider the following before relying opinion of Adam Feuerstein. Feuerstein failed to consider that is that Bio-t-Gel uses AIS transdermal technology which is in all likely hood a better delivery method compared to competition.
Secondly, Feuerstien indicated the cancer program was worthless, if he had done a little research he would have noticed that Lancet Oncology has a couple of articles from 2012 about the promise of GVAX. I think they have the upper hand when it comes to an informed opinion. GVAX is presently being used in conjunction with other drugs to treat cancer and the results have been impressive. Much the way drug cocktails were required to treat Aids In addition a simple comparison of the pipelines of other companies focusing in oncology research would show many have a $300+ million Market Cap with arguably much inferior promise.
Next what many not realize is that Biosante recently filed for two patent applications with respect to Libigel and it's cardiovascular benefits. Hardly the move for a dead product, in reality Libigel could prove to bigger then originally projected.
Lastly, Biosante still owns the global rights (excluding the US) to Bio-t-gel and Elestrin. Quoting Biosante as an 11 cent/share company obviously did not factor in any of the above information
The information I have provided you is easily verifiable.
It is the proliferation of such outdated or less informed articles that mislead the reading audience. But even worse could prevent or delay an important cure. Your institution and The Street owe it to the readers to verify your information and not take everything at face value.
The PR release form his meetings with the FDA should give a well needed boost.
I agree, it was the exchange of information between The Professor and Jeff on Yahoo that got me to do some digging.
When stocks are as manipulated as much BPAX,it makes it easier to suppport a Transaction tax. If we are going to get jerked around, they might as well help pay the country's debt.
According to Adam F the cancer program is worthless. How much does he know about cancer research? ZERO if he actually believes what he writes.
Now, The Lancet Oncology knows a thing or two about cancer.
Lancet GVAX
I couldn't agree with you more. For those that listened to Simes' conference, he sounded like a proud parent speaking about his children when he spoke about Biosante. He is not going to throw out his baby with the bath water. If people really researched the company and the pipelines (understand the product) and do some research of the competition and their pipelines,you'll be hiding your shares from your spouse.
I work during the day, that is why I am an investor and not a trader. As for today, obvious big time manipulation by firms trying to get out of a pickle. This in addition to the class action (timing of release to coincide with positive news by Biosante) furthers the manipulation. Buddy from yahoo was smart enough to collect two months of data. It will be compelling to the SEC to see the pattern as opposed to one days activity. If the funds and the Law firms get a whiff of this they will back off if they are smart and start trying to cover their tracks. I am not familiar with US laws on these matters. But in Canada you don't even have to prove the offence was committed. You can charge them by proving they conspired to commit the offence. If buddy from Yahoo was that thorough they no doubt have enough to support charges if they follow up on the investigation.
If the firms back off BPAX should rise quickly.
Interestingly the 21 people who were laid off by Biosante may have a case against them as well.
Info like this hitting the wire would be better then any PR as the regular investor would see this as a sign that BPAX was grossly undervalued.
Should make for interesting times.
Interesting post by MPR 12001 on Yahoo board
I file a formal compaint with the SEC
on the manipulation and selling of shares not owned or under book hold. I also provided the SEC with transcripts of the last 2 months worth of trading data to show the manipulation. The companies involved will not have the proof to show they could cover their short selling. I did this 2 times before and I may tell you that the SEC took action and one of the funds was shut down and another paid a hefty fine. There was fraud involved in the last company stock transaction. I would advise anyone who want to file a complaint with the SEC to do so. The more they have the better off. I know of about 38 people (6 lawyers) who have done so. It is you right. Short selling with the cover of a purchased share on hold is illegal. I have the proof and presented it. Stay tuned because we may have a class action lawsuit against the funds and the law groups who assisted in this. They were named in the SEC complaint filed today.
I bought for 40% flip , after crash bought more for Libigel. Now I am in for GVAX. The faster it gets here the sooner I retire.
It took almost 2 months to get from $0.50 to $1.00, possibly $2 by mid April and $4 by June in time for Libigel safety trial results.
Any buyout should be more then a couple of bucks. In September they had a 1 yr target price of $6.00 Since then the Bio-t-gel has been approved. Libigel may be bigger then expected with the CV benefit. If anyone has actually compared BPAX cancer program to that of other companies you will realize the cancer program itself is worth $3/share. A serious offer should be in the $8- $9 range.
You only lose if you sold prematurely, therefore you contributed to your own demise. No case. Next case on the docket please.
Consider the possibilities. Since Biosante is a science driven, research intense company as confirmed by Patent scorecard
BPAX Science Strength
It is very feasible that we could be looking at valuations similar to Regeneron ($10.19 Billion) within 5 -7 years. Possibly higher since Elestrin, Bio-t-Gel, Libigel and The Pill Plus and possibly even Cancer vaccine revenues should all create a greater annual revenue stream. I realize this is premature. But the foundation is the research and when it comes to research intensity BPAX is rated highest.
Regeneron
For the educated investor it was never on the table. Just a formality the company would never had let it happen.
Investor ignorance is what dropped the price. Many thought BPAX was a one drug company, Libigel. It had a set back when the placebo (which by the way looks like it was steroids) did as well as Libigel in the sexual satisfactory events. The rest of the pipeline did not exist. This was not helped by the uneducated postings of some Seeking Alpha bloggers and Adam Feuerstein of the Street.com and ambulance chasing law firms. If any of them had evaluated the company and did their due diligence and actually compare them to their competitors they would have realized it was grossly undervalued at $2.50, let alone $0.40.
Know what you are investing in. This way you never hold onto it too long or get rid of it too early.
If Teva gets it they are in 58 other countries. It is big.
Much more when people realize the cancer program potential.
HAPPY VALENTINE'S DAY EVERYBODY
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