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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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Even if they have been advised I believe Simes would be attending the closing plenary of the conference prior to making any announcement. If Teva is there as well they may release info afterwards. I believe both would want to sit in on the plenary. If I were CEO I know I would.
BIO CEO 2012 Closing Plenary
Inside the FDA
Tuesday, February 14th, 4:00pm-5:00pm
With PDUFA V reauthorization looming and the implementation of follow-on biologics legislation continuing, 2012 will be a big year for the FDA. Senior leaders from the FDA, BIO, and the industry will convene to discuss the legislative and regulatory environment, and what is in store for the FDA in the coming months and years.
On a side note writers or analysts like Adam Feuerstien create great opportunities. It is like a movie critic. If you know you prefer movie a critic recommends and the critic consistently recommends movies you like follow their advise. Likewise if you never like the movies a critic recommends start going to movies they trash. As long as the Critic is consistent.
From what I can tell AF does not do much due diligence, so when he start trashing a stock. Take a good look at it, it may end up being a good buy. The sheep will follow AF's advice creating an undervalued buying opportunity. I know that from now on I will be looking to AF's articles for buying opportunities (not what he recommends)
Joshuri, you are not alone, This was the second time I had been in BPAX this time since July. I looked at Dec 15 as a very good sale and played the bounce that didn't happen immediately. Started second guessing my self over the holidays. Did a lot of research and looked to corroborate any information that was learned. By New years I couldn't wait to buy more. I am actually at a profit now, but with what I have learned. I am in long term now at least until the value of the Cancer program has been incorporated into the share price and most likely until GVAX is approved. Who knows BPAX, in time, has the potential to become a very lucrative dividend paying company.
This is mostly for those new to BPAX. I have tried to keep my posts based on factual information and analysis that I found. I have attached the post I have added to this board to simplify your education process. Please note the information is accurate to the date it was posted so some dollar values will change as the share price changes I am a value investor not a day trader. So if you are looking for charts you will not find any.
BPAX Fact Based Information
Hope it helps
Found an interesting post on yahoo, unknown if the person actually worked with GVAX. But he states he has worked with GVAX and that it is superior to Provenge. But that GVAX approval would be a decade away. Jeff counters that with the 4 orphan drugs in Biosante's lineup. Trial and if successful approval would be fast tracked from 1 to 2 years. The people that need don't have the luxury of time. Note: From examining Jeff previous posts he appears very well informed.
Yahoo post
If both of these statements are true. It would greatly benefit the stock price. Denreon has only one product, Provenge and a small pipeline yet the company has $2.15 billion Market cap. Could make for interesting times.
The only longs sweating are those who have not educated themselves on how Biosante the company (not the stock) compares against other companies in the same industry. Since Biosante has cash, they have time. So look at the competitors pipeline and get to know the competition. As a long, regardless of what happens today you will sleep well, it will just take more time. Those who were in early, if news is negative, it could create another opportunity to pare down the average cost per share by buying more.
Teva only has right to the Bio-t-gel in the US, the right to the rest of the world still belong to Biosante. So yes approval will mean something to BPAX. In all likelihood Teva would negotiate a new licencing agreement which would be more profitable for BPAX for the remaining rights. Teva has around 47,000 employees in over 60 countries. Feb 14th PDUFA is about BPAX getting the foot in the door.
In December BPAX traded around $2.50 until efficacy results. If Bio-t-gel is approve and Libigel is back on track with a Cardiovascular Benefit expect to conservatively be trading north of $3.
Note: this price does not factor investor realization of worth of the cancer program. If this too is addressed in the conference you are possibly looking at $4 - $5 pps