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Professor, I think if you look back far enough you had the proper year in one of you posts. That is what prompted me to check.
If you look at the Libigel Brochure and I am certain you have seen the comparative results and Libigel vs Intrinsa. The comparison was for estrogen enhanced testing a straight up comparison.
I also remember in one of Simes conference calls mentioning that phase II efficacy results were quite high and expected results in phase III to be a lower. Libigel acted as expected. No doubt, because they would not be using estrogen in phase III.
Do you suppose this was by design by the FDA to give physicians options in treatment. The prescribed method of treatment would start with Libigel and if the response is not acceptable support Libigel with estrogen treatment. Biosante realized or were informed that the increased risk, by purposely reducing Libigels efficacy, could be offset with a 505(2)(b) NDA application?
I don't know if that was their original intention,I believe they left all their doors open, partnering, selling the company or going it alone. They know the value of what they have in Libigel and GVAX and were not going to give it away. You are correct that some time in the future they would have to increase the number of available shares and since plan A to elevate the price wasn't working they quickly went to plan B, the R/S.
They have initiated the steps to commence manufacturing. It will be interesting to see if they take the next big leap and jump into the marketing field. If we see any positions posted related to marketing. We will know how far they intend on going it alone. Even if they end up partnering, an exclusive market and the further they take the product to approval, the greater royalties they can command.
Keep in mind Biosante has a number of other products for them to work on when revenue starts to come in. I was doing research on A2/Furin which Novartis played with and liked how it performed. A2/Furin boost the effectiveness of stem cell treatments. Like GVAX it appears to play nice with other treatments. As a result I see sustained sizable growth for a long time. As the professor had previously mentioned, this company should eventually makes its way into a persons retirement portfolio, if it all works out we will have been fortunate to have gotten in when we did.
I like how Jazz, in under three years, has taken their pps from $0.60 to above $50, trading at $42.10 today. This was achieved through good products and strategic merger. Hopefully Biosante will experience similar success.
Professor, I just searched the last 4 annual 10ks for Biosante. The first time I could find mention of the 505(b)(2) NDA is in the 2010 10k filed 2011-03-16.
I don't know if the Bloom trial changes, eliminating the estrogen requirement led to the inclusion of the use of 505(b)(2) NDA in the 10k . But the timing works.
Professor, it appears up until the Oct 20, 2010 for the Bloom trial they had planned to use women taking a stable dose of estrogen.
proper trial change link
In the end you are right they did not have estrogen use as an inclusion criteria. Something happened to change this.
Libigel Safety Study has 3656 patients enrolled of which as of April 2011, out of 2899 enrolled patients,including:
Hypertension - number of patients in the trial = 1962
Dyslipidemia - number of patients in the trail = 1870
Diabetes mellitus - number of patients in the trial =608
If the enrollment ratio remained the same. The following would be the final estimated enrollment.
Hypertension - number of patients in the trial = 2474 approx.
Dyslipidemia - number of patients in the trail = 2358 approx.
Diabetes mellitus - number of patients in the trial = 767 approx.
Located the following Phase III Clinical trials.
Perindopril Amlodipine for the Treatment of Hypertension (PATH)
Est. Enrollment 816 patients
Trial
A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension
Enrollment 564 patients.
Trial
Olmesartan in Essential Hypertension (Placebo trial)
Enrollment 2333 patients
Trial
Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia
Enrollment 1267 patients
Trial
From examination of trials with similar conditions it appears that there should be enough data to support the inclusion of Hypertension and Dyslipidemia in NDA submission. Though a number of Diabetes phase III trials had less the patients then the Bliss trial. This condition will probably require more work.
Something else to calm the nerves, Louis W. Sullivan, M.D. Biosante's Chairman of the Board of Directors sat on BMS's Board for 2005 and 2006. If he was good enough for BMS then we should be in good hands.
Sullivan
Medicaz, came up with 15 trials none of them with GVAX.
BMS-936559
BMS-936558
Jadite, it appears that efficacy information where the FDA voted 14-3 in favor of the efficacy of Intrinsa could be used.
I have attached a power point look at pages 7 onward shed light on how 505(b)(2) NDA works.
NDA Process
No problem. You guys did the heavy lifting. I just brought the Pizza and Beer.
Jeff, Professor, could it be because 2010-10-20 they updated the bloom efficacy trial to remove women taking a stable dose of estrogen therapy.
This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women taking a stable dose of estrogen therapy.
to
This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.
Bloom trial change
Makes sense Professor, in some cases the company has to sweeten the pot to make it happen.
Interesting to see two presentations yesterday with respect to Gender Issues in Coronary Artery Disease at the National Lipid Association meetings. This could benefit Biosante in the future.
10:45-11:05 am Testosterone Therapy in Men and Women Margaret E. Wierman, MD
11:05-11:25 am Women, Hormones & Heart Disease Who/what to believe in 2012 Elizabeth Barrett-Connor, MD
Agenda
Ultra conservative calculations. But you make a very good point.
The best way to expedite the climb would be to immediately release all the hold back information followed by large insider purchases.
This would send a loud and clear message.
The price will then work its way up over the summer where they can make an offer of less shares to finance the manufacturing facility, the NDA run and anything else on their product development to do list.
Until they make the information available, the insiders hands are tied.
If this is how Biosante intends to play it, the covering by shorts just got whole lot more expensive.
Good point.
Alpha it was a joke by DD. 6 bagger in share price at the expense of the number of shares. Regardless of the pre-market it was still a good joke.
True but the if management are playing games, and I were on the Board of Directors, I would put a quick stop to it.
Every indication is they are for real.
Medicaz, that is how I first found out about Biosante. My investment adviser steered me towards Bpax for the PDUFA early and made a quick 40% return. I got back into it got in June or July oddly enough at the same price of the first purchase. My investment adviser is a also a personal friend for over 25 years and is a Regional Manager for a very large Insurance/investment company. No pre-warning as most to the December crash. Their line was to stand pat, until they found out more. He called the company, I can't remember if he spoke to Simes or Donemberg. Anyhow there guidance indicated that early June would be when activity would heat up and final decisions on Libigel would be made.
I made the connection with the Jeffries Conference. The timing very coincidental.
Anyhow thanks to the cumulative efforts of the board I know more about Biosante then my friend (adviser). I fill him in from time to time.
Welcome aboard,the more contributors the better.
Good pick up penniepincher, but even more importantly they have removed the Director of Quality Assurance. They must have found someone.
No doubt he/she will have input into the CAPA Manager position.
Careers
A pattern is developing Fridays appears to be their careers posting days. All three postings have been on Fridays.
Very good point.
FYI, last year they announced the last Libigel patient had been enrolled and that the Hold on GVAX Prostate had been lifted during the week prior to the Jeffries Conference.
Well done DD
Hoggydog, I didn't say what indication the NDA submission would be for,the Professor provides good rational for a Testosterone NDA submission, but including CV would depend on the FDA meetings.
I posted this info regarding the Bliss safety trial for Libigel earlier, if you haven't read it it might help you understand where I am coming from.
Bliss info
Bliss Trials Primary Outcome: The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects
Primary outcome
I recommend reading the replies they provide context as to potential markets for each indication they were testing in the Bliss trial.
Note: If additional trials are required for Hypertension and Dyslipidemia, you must admit they have a very good leg up for a Phase IIIb trial.
Macerimmer, I agree that the simplest explanation is usually the right one. However when heavy stock manipulation is permitted the simplest is not always the correct hypothesis.
That is why we look for corroborative evidence. The pipeline, the cash on hand, the validation of the quality of their science as supported by the Patent Board, Vie Awards, John Hopkins, Aduro, Teva, Jazz etc...
Then look at the Board and the management Team research their back ground they are diverse and not an incompetent group.
When the simplest explanation doesn't add up and you still go with it. Then you have a negligent investigation.
That being said the communication and transparency of the company stinks and one has to wonder why. A piece of the puzzle is still missing. Basically I look at possible motives for the lack of communication. In the end you may be right, in my mind there are too many unanswered questions to leave it at that.
Hopefully we will find out soon.
I realize some are worried about a pump and dilution by the company. However in the following scenario it would make sense.
Assuming the FDA meetings went well and Biosante is intent on making an NDA submission for Libigel. This takes cash. Now that the R/S will have been completed, they announce that their intention to submit an NDA submission along with releasing the fact that Libigel reduces the risk of cardiovascular events by 71% in post menopausal women for which they have submitted patent application and that they have started the hiring process to facilitate the manufacturing of Libigel.
Would this not boost share price to a level that requires less shares being issued to support their Libigel run to approval and production.
If this is their plan. I can live with that as the price increase will more then compensate for the issuing of additional shares.
Jeff, I agree, it was also interesting that Tang was trusted enough to allow accumulation post R/S up to 20% but prior to any merger he agreed to get back down to 10%. As you have previously stated their is a unique relationship here. I believe, if the company is not sold, Tang will eventually become a board member.
Macerimmer, I don't know about that, nothing about this company's valuations have been normal including the 80% drop in December. Since then a series positive events which would normally bring up the price of the company ie, FDA approval of bio-t-gel, positive GVAX trials results. They still were not able to shake the manipulation and have been sitting at or below cash.
BY doing the R/S as some have said it put the stock in a position to be picked up by an increased number of funds.
I believe they opted to hold back info to insure when good news is released the share price acts as expected and not manipulated downwards.
The following is information has yet to be released:
The patent applications in relation to the CV benefits
The patent application for commercial production of Libigel
The three job posting, Director of Quality Assurance, CAPA Manager and a Clinical Research Assistant.
The result of the trial extension
The results of the FDA meeting.
The final enrolled patient just passed the one year mark. Safety update could be available. This is also the point at which the FDA will consider submission of NDA (obviously if this is the case there is still work to do). Fall submission is most likely.
Teva Bio-t-gel update(possibly)
The GVAX vaccine being nominated one of the top 5 vaccines in the world.
Being runner up for the same ceremonies for their licencing agreement with Aduro.
And this is the news that we have uncovered as a group for which Biosante has sat on. Who knows what else they have been sitting on.
I believe this is why you see some hugging on the board. It is time to turn the page and move up.
You may have felt burnt buy them in the past but management and the board have held their shares for longer then most of us. Some of the Board Members have a much greater position then most. Even if some are wealthy, they don't get there by throwing away their money.
The method to their madness should soon be revealed.
Very good point Dion.
Last year going into the Jeffries Conference (it is a Major conference) they had a number of announcements. I think this year it started tonight. Lord knows they have a lot they have yet to release.
Jeff the numbers work out the share count was reduced accordingly. The aggregate dollar value remained the same. The specified events could relate to the previous agreement where he could not own more then 20%. But with Tang who knows.
That gives them room to get the financing to make the run at Libigel to the finish line.
Jeff, I have located cases where the R/S was used to support a merger, other cases where it support the sale of part of the company and subsequently paying out a dividend to the new share count, post sale. I am wondering if it lays out the foundation all for what they will be presenting at the Jeffries conference June 6th.
See Link
Reverse Split
I was reading up on some cases where the R/S have been used to facilitate mergers. However. the timing in this case seem to fit the 10 days above $1 reasoning.
Is the CLINICAL RESEARCH ASSISTANT - L3 position posted Biosantes Career page an indication of multiple clinical trials on the horizon. The person will report directly to Joanne Zborowski (Vice President, Clinical Development) whose experienced in the fields neuroscience, oncology and cardiovascular.
ESSENTIAL FUNCTIONS:
Provides support to clinical development to assist with execution and maintenance of clinical studies.
Maintains, tracks, and updates, various databases for clinical tracking.
Maintains clinical trial master files (TMF).
Supports the completion of proper and timely tracking of clinical documentation and performs regular quality control of TMF for completeness and accuracy on an ongoing basis as outlined in the relevant SOPs and guidelines to ensure the inspection readiness.
Collaborates with other internal departments to update and manage site information in CTMS.
Disseminates information to investigational sites, regional monitors, and clinical team as directed.
Liaises with Central IRBs and clinical study sites and clinical team members for IRB/IEC submissions and approval.
Communicate with investigative sites to resolve any site-related issues.
Responsible for ordering and shipping supplies in coordination with all phases of the clinical studies, maintains files and inventories of chemicals, supplies and equipment.
Manages documents related to clinical trials including study participant data or study related medical records.
Processes, logs and distributes completed case report forms.
Prepares materials and attends training meetings.
Follows standard operating procedures.
Welcome to the Board KaptKos. I find the group here, for the most part, is fairly knowledgeable and bring diverse strengths. Hope you enjoy a similar experience.
Currently in Phase 3 is BioSante's GVAX pancreatic cancer vaccine, which uses inactivated pancreatic cancer cells to stimulate the immune system. The vaccine has already been successful in Phase 1b clinical trials, where it increased median survival of patients with previously treated, locally advanced, or metastatic pancreatic adenocarcinoma from 3.3 months, when treated with ipilimumab (Yervoy, Bristol-Myers Squibb), to 5.5 months. In Phase 2, when 60 pancreatic cancer patients received GVAX after pancreatic resection, their median survival time increased from 17.3 months (95% CI, 14.6–22.8) to 24.8 months (95% CI, 21.2–31.6); the vaccine was also generally well tolerated.
From the article Raising Hope for Pancreatic Cancer, Dr Netterwald references the Phase II results which are posted on Biosante's website.
Could Netterwald know something?
Biosante Cancer webpage
Joshuri, if they issue new shares for research only then it can drain pps. If they are raising the cash to build a manufacturing facility, an NDA submission and even a marketing team. Then the expectation of revenue is increased and this pushes up the price. Funding a dream vs funding a product.
I think they are about to start a Phase 3 GVAX Pancreas trial.
In the article Raising Hope for Pancreatic Cancer James Netterwald refers to a Phase 3 trial.
Raising Hope for Pancreatic Cancer
At first I thought it was a typo and should have been Phase 2
But I then looked at the GVAX trials open and closed. When I looked at the last changes dated Sept 8, 2011 in the following trial
Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
I noted a number of changes and additions, it looks like the set up for the next trial. These changes and additions may occur during a trial, but at the end?
Trial changes
Professor, I should have explained it a little better. If they were stringing us along with the intention of shutting down the safety trial. I would start questioning the validity of the information within the patent applications. If the information as stipulated is correct you would continue the safety trial for this purpose alone. Once again, sorry for the confusion.