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goodplenty100 we need a heavy partner anchored at the other end of the rope soon so we can pull all of these short fellas across the mud vat.
BIO Yes one of many future collaborations. Bayer partnered with Onxy for rights to Sorafenib to treat liver cancer in Asia so beta bodies should factor in due to its characteristics to possibly treat dense cancer in liver.
Bayer still has Peregrine on their list of collaborators.
Feb'12-Mar'13 ~8 times: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia:
To whom it may apply.
Thanks for being concerned and thinking about us share holders.
I understand where this is coming from.
I have a different view as a long term investor in the biotech
sector. My investments in AZN, MRK,BMY,ICPT and JNJ plus a few other smaller biotech's have positioned me well.
While this is my first experience on a message board I can clearly state one thing, I know how to invest. This message board has it's value in CJ, Couch, Sunstar, MH, CP and few others for their perspective and knowledge they bring into discussion and debate. Not to mention the research which is very handy for a busy person.
The point I am making to all investors I encourage you to go with your research and the science behind it and hold your investment more times then not you will profit and of coarse the patients will.
Bavi is a winner and will be approved based on my assessment of all the scientific data. Many labels will follow after approval. Dr. Brekken will bring it home.I understand many have waited along time for this so let's see how things develop.
BIO Later down the road I believe Beta bodies can be useful for liver cancer with Sarofenib.Bayer took Southeast Asia from Onxy for liver cancer.Which happens to be an area with incidence of liver cancer.
Another possible label for Bavi?
First online: 04 February 2016
Antibody-Mediated Blockade of Phosphatidylserine Enhances the Antitumor Effect of Sorafenib in Hepatocellular Carcinomas Xenografts
Xiaoyun Cheng , Li Li , Philip E. Thorpe, Adam C. Yopp, Rolf A. Brekken , Xianming Huang
Abstract
Background
Currently, the only FDA-approved systemic therapy for hepatocellular carcinoma (HCC) is the multi-receptor tyrosine kinase inhibitor, sorafenib, which provides only modest clinical benefit. We recently showed that treatment with a phosphatidylserine (PS) targeting agent suppresses tumor growth by targeting tumor vasculature and reactivating antitumor immunity.
Methods
We tested the hypothesis that sorafenib increases PS exposure on tumor vasculature, thereby enhancing the antitumor efficacy of PS targeting. We evaluated the efficacy of combining a PS targeting agent (2aG4) with sorafenib in murine xenograft models of human HCC.
Results
Our results demonstrate that combination of 2aG4 and sorafenib had a superior therapeutic effect over single agent therapy. Mechanistic studies showed that sorafenib significantly increased PS exposure on tumor vasculature; the percentage of PS-positive vessels increased from 19 to 52, 23 to 68, and 30 to 55 % in PLC/PRF/5, C3A, and Huh7 tumors, respectively. Combination therapy significantly decreased tumor microvessel density and the level of M2 macrophages, while increasing the apoptotic index of tumor endothelial cells and the frequency of M1 macrophages. Furthermore, we report the findings of a Phase I clinical study of bavituximab, a chimeric version of 2aG4, combined with sorafenib in HCC patients. The Phase I results demonstrate the appropriate dose of bavituximab to be given with sorafenib in future clinical trials.
Conclusions
Overall, these results strongly support the combination of bavituximab with sorafenib as a promising systemic therapeutic strategy for the treatment for advanced HCC patients.
Yes potential is very broad.
BINGO That's why Bavi will be approved. Or as 101T would say BRAVO.
Very good Thanks cheynew. EOM
ECOG 0 & 1 makes a difference due to MOA of BAVI
These arms in SUNRISE will not be mixed.
In my assessment Bavi will do very well based on these two points alone.
I think BIO had some information about Kathy Miller? Perhaps I am confused with another person
Investigators
Study Chair: Kathy Miller, MD Indiana University Simon Cancer Center
01/20/16
Roth Capital
buy
$3
01/13/16
FBR Capital Markets
outperform
$3.5
12/14/15
Noble Financial
buy
$5
06/01/15
MLV & Co
buy
$3.5
05/18/15
Zacks
hold
100% positive
$3.5 Median
CP excellent summation of facts. EOM
SUNRISE
This study is ongoing, but not recruiting participants.
ClinicalTrials.gov Identifier:
NCT01999673
PPHM has won big time with Bavi and SUNRISE will get approved and patients will benefit. This is my assessment. Everything else will work itself out from there.
Most know what it is established for lets review some of this.
A shareholder rights plan, colloquially known as a "poison pill", is a type of defensive tactic used by a corporation's board of directors against a takeover. Typically, such a plan gives shareholders the right to buy more shares at a discount if one shareholder buys a certain percentage or more of the company's shares. The plan could be triggered, for instance, if any one shareholder buys 20% of the company's shares, at which point every shareholder (except the one who possesses 20%) will have the right to buy a new issue of shares at a discount. If every other shareholder is able to buy more shares at a discount, such purchases would dilute the bidder's interest, and the cost of the bid would rise substantially. Knowing that such a plan could be activated, the bidder could be disinclined to take over the corporation without the board's approval, and would first negotiate with the board in order to revoke the plan.[1]
The plan can be issued by the board of directors as an "option" or a "warrant" attached to existing shares, and only be revoked at the discretion of the board.
In the field of mergers and acquisitions, shareholder rights plans were devised in the early 1980s as a way to prevent takeover bidders from negotiating a price for sale of shares directly with shareholders, and instead forcing the bidder to negotiate with the board.
Shareholder rights plans, or poison pills, are controversial because they hinder an active market for corporate control. Further, giving directors the power to deter takeovers puts directors in a position to enrich themselves, as they may effectively ask to be compensated for the price of consenting to a takeover. Shareholder rights plans are unlawful without shareholder approval in many jurisdictions such as the United Kingdom, frowned upon in others such as throughout the European Union, and lawful only if used "proportionately" in others, including Delaware in the United States.
The poison pill was invented by mergers and acquisitions lawyer Martin Lipton of Wachtell, Lipton, Rosen & Katz in 1982, as a response to tender-based hostile takeovers.[2] Poison pills became popular during the early 1980s in response to the wave of takeovers by corporate raiders such as Carl Icahn. The term "poison pill" derives its original meaning from a poison pill physically carried by various spies throughout history, a pill which was taken by the spies when they were discovered to eliminate the possibility of being interrogated by an enemy.
It was reported in 2001 that since 1997, for every company with a poison pill which successfully resisted a hostile takeover, there were 20 companies with poison pills that accepted takeover offers.[3] The trend since the early 2000s has been for shareholders to vote against poison pill authorization, since poison pills are designed to resist takeovers, whereas from the point of view of a shareholder, takeovers can be financially rewarding.
Some have argued that poison pills are detrimental to shareholder interests because they perpetuate existing management. For instance, Microsoft originally made an unsolicited bid for Yahoo!, but subsequently dropped the bid after Yahoo! CEO Jerry Yang threatened to make the takeover as difficult as possible unless Microsoft raised the price to US$37 per share. One Microsoft executive commented, "They are going to burn the furniture if we go hostile. They are going to destroy the place." Yahoo has had a shareholders rights plan in place since 2001.[4] Analysts suggested that Microsoft's raised offer of $33 per share was already too expensive, and that Yang was not bargaining in good faith, which later led to several shareholder lawsuits and an aborted proxy fight from Carl Icahn.[5][6] Yahoo's stock price plunged after Microsoft withdrew the bid, and Jerry Yang faced a backlash from stockholders that eventually led to his resignation.
n publicly held companies, "poison pills" refer to various methods to deter takeover bids. Takeover bids are attempts by a bidder to obtain control of a target company, either by soliciting proxies to get elected to the board or by acquiring a controlling block of shares and using the associated votes to get elected to the board. Once in control of the board, the bidder can manage the target. As discussed below, targets have various takeover defenses available, and several types of defense have been called "poison pills" because they harm not only the bidder, but the target (or its shareholders) as well. Currently, the most common type of takeover defense is a shareholder rights plan.
Because the board of directors of the company can redeem or otherwise eliminate a standard poison pill, it does not typically preclude a proxy fight or other takeover attempts not accompanied by an acquisition of a significant block of the company's stock. It can, however, prevent shareholders from entering into certain agreements that can assist in a proxy fight, such as an agreement to pay another shareholder's expenses. In combination with a staggered board of directors, however, a shareholder rights plan can be a defense.[7]
The goal of a shareholder rights plan is to force a bidder to negotiate with the target's board and not directly with the shareholders. The effects are twofold:[8]
It gives management time to find competing offers that maximize selling price.
Several studies indicate that companies with poison pills (shareholder rights plans) have received higher takeover premiums than companies without poison pills. This results in increased shareholder value. The theory is that an increase in the negotiating power of the target is reflected in higher acquisition premiums.
Preferred stock plan
The target issues a large number of new shares, often preferred shares, to existing shareholders. These new shares usually have severe redemption provisions, such as allowing them to be converted into a large number of common shares if a takeover occurs. This immediately dilutes the percentage of the target owned by the acquirer, and makes it more expensive to acquire 50% of the target's stock.
Flipover rights plan
The target takes on large debts in an effort to make the debt load too high to be attractive -- the acquirer would eventually have to pay the debts.
Ownership flip-in plan
The company buys a number of smaller companies using a stock swap, diluting the value of the target's stock.
Back-end rights plan
Under this scenario, the target company re-phases all its employees' stock-option grants to ensure they immediately become vested if the company is taken over. Many employees can then exercise their options and then dump the stocks. With the release of the "golden handcuffs", many discontented employees may quit immediately after having cashed in their stock options. This poison pill is designed to create an exodus of talented employees, reducing a corporate value as a target. In many high-tech businesses, attrition of talented human resources may result in a diluted or empty shell being left behind for the new owner.
For instance, PeopleSoft guaranteed its customers in June 2003 that if it were acquired within two years, presumably by its rival Oracle, and product support were reduced within four years, its customers would receive a refund of between two and five times the fees they had paid for their Peoplesoft software licenses. While the acquisition ultimately prevailed, the hypothetical cost to Oracle was valued at as much as US$1.5 billion. [9]
Common types of poison pills
Voting plan
In a voting plan, a company will charter preferred stock with superior voting rights over that of common shareholders. If an unfriendly bidder acquired a substantial quantity of the target firm's voting common stock, it then still would not be able to exercise control over its purchase. For example, ASARCO established a voting plan in which 99% of the company's common stock would only harness 16.5% of the total voting power.[10]
In addition to these pills, a "dead-hand" provision allows only the directors who introduce the poison pill to remove it (for a set period after they have been replaced), thus potentially delaying a new board’s decision to sell a company.
Plus much more.....but will suffice.
Well we are approaching some milestone PR'S hope your objectives are met. GLTU
bidrite added more this morning to.
To be commended. EOM
Glad CJ redirected this POST from RRdog. I missed this one somehow.
Excellent tradero very instructive charts for us investors to mull over.
Plus thanks to the other contributors Mojojojo & GOLFO.
Krak Good to hear. There is power in prayer coupled with all you do to get better.
CJ Have watched numerous videos and studied many posters/slides.
The MOA of this chimeric molecule is very intriguing. The science is fascinating. While the micro environment is very complicated
this PS binding ability on a global scale will be of strategic importance for all future combo treatments in many indications.
This last presentation unlocked many questions.
sunstar excellent points made.
Yowsa up 34% in pre. UGH no vol. Maybe T101 bought 101 as subliminal message to us all. You have now enter the twilight zone.....
BIG BINGO! more shares added today
Only around 3.9%
EX thanks for explanation.
I would assume the 80% unbinding was part of the planned arrangements when DR. Garnick was negotiating with FDA on trail design for SUNRISE.
SK is holding is own on presentations. Always room for improvement though.
CJ Good presentation by SK. See lots of potential for bavi.
I would agree with that assessment.
Little news from potential partners?
GSK, AstraZeneca and J&J back $57M effort to springboard university drug research
January 25, 2016 | By John Carroll
Three of the U.K.'s leading universities are joining hands with three of the world's biggest pharma giants to create a new translational medicine group aimed at spinning out new therapies into the global pipeline.
Imperial College London, University College London and the University of Cambridge--all recognized for top academic research organizations with a long track record in drug discovery--are joining hands with GlaxoSmithKline ($GSK), AstraZeneca ($AZN) and the J&J Innovation group ($JNJ) on the creative new fund. The tech transfer units at the universities are each chipping in £3.3 million while the Big Pharmas are adding £10 million each.
That money is being poured into the Apollo Therapeutics Fund, which is recruiting a group of ex-industry scientists who will be charged with shepherding the best new preclinical programs that can be shoved into development. The big three pharmas get the pick of the litter at the university consortium through an internal bid process, while the rest can be spun out in an outlicensing deal.
Ian Tomlinson, a former senior research exec at GSK and Domantis, will chair the new pipeline project's steering committee, which aims to strike deals that will divvy up royalties and milestones on everything from small molecules, peptides, proteins, antibodies and cell and gene therapies.
While not nearly as big as many of the new private venture funds being rolled out in the U.S. and Europe, this is a much more carefully focused effort that could help redefine the way that the industry accesses early-stage science for their pipelines. Several venture groups in the U.S.--like Flagship, Polaris and Third Rock--have specialized in picking the top academic efforts and creating new biotechs around the research. And Big Pharma groups have been going direct as well at times. J&J Innovation has been setting up new academic ties around the globe, while GSK has partnered on its own outreach efforts and AstraZeneca is relocating its HQ to Cambridge.
This new joint venture in the U.K. could help universities orchestrate their tech-transfer programs and pump up their returns, while giving the Big Three a first shot at the most promising new treatments.
The move also underscores a debate inside the pharma world over the most efficient way to go about drug research and development. Some analysts question how efficient a large operation can be in accessing preclinical work and advancing it into the clinic. For them, it makes more sense to wait until after a biotech has taken a therapy through the proof-of-concept stage, where they can pay a premium for products that can be advanced into late-stage programs with relatively near-term readouts. GSK, Astra and J&J, though, are betting heavily that their early stage work will pay off later by being the first to market with the most innovative therapies.
"This is the first time that three global pharmaceutical companies and the TTOs of three of the world's top ten universities have come together to form a joint enterprise of this nature, making the Apollo Therapeutics Fund a truly innovative venture," noted Tomlinson in a statement.
GOV is closed tomorrow
CP
Need effective management to navigate these results.
Furthermore after reading through your outline it helps the new investors focus in an what may very well be an investment of a lifetime for such a low PPS IMO
8) With the AbbVie deal we had a going concern, almost no cash on the bank and a 15Mil$ bank depth at 7.5% plus an option for another 15Mil$ depth on PIII approval and a going concern. Furthermore Avid production was very low. Now we have ZERO depth, no going concern, 70Mil$ cash on the bank and Avid breaking revenue, backlog and new contracts record after record at about 50% gross margin WITHOUT our new Avid II facility even being in commercial production at the last Q/CC.
Hutschi as you are aware Bavi side effects are relatively nominal by comparison and a good candidate for combination treatment. Need upstream treated for cascade affect downstream. The outer membrane lipids (PS) is the master switch. Bavi the Global switch inhibitor and immune response signal generator will work synergistic with down stream programmed death molecules. Results more robust treatment. Come on SUNRISE
Bavi has a role to play.
Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; and embryofetal toxicity.1 Please see the Important Safety Information section below, including Boxed WARNING for Yervoy regarding immune-mediated adverse reactions.
BIO This why I keep adding more shares mentions like this.
Potential!
I think all should sleep peacefully this weekend after seeing Raymond Birge pop up yet again and would you think JnJ takes notice of Raymond Birge?
Good info. Thanks
Bluerinse, I agree with your sentiments since I have introduced PPHM to several friends and colleagues. Many have added thousands of shares in recent months after researching pipeline through their own initiatives by my recommendation.
FierceBiotech
The biggest winners--and losers--in the 2015 race for new drug approvals
Let's start with the good news. In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs. The new generational high, easily lapping last year's list of 41 approvals, marks a new peak following a surge by the R&D side of the business, which continues to recover from a lengthy period of marked weakness. The FDA has helped, proving more than willing to come through with faster approvals, particularly in oncology. And the science around drug development has improved markedly as our understanding of the genetic drivers of disease continues to make real progress.....