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>Bavi’s ability to double or triple the number of responders through combinational immunotherapy for cancer treatment, will be the medical benefit.<
What about safety? How much safer are the immunotherapy drugs are going to be with Bavi as opposed to by themselves?
I don't know. Most people on this board would agree that you would have to subtract billions in a PPHM sale because of management. And I don't think there is anybody on this board who wouldn't take 10 billions right now.
I have not thrown the towel in. As strange as this might sound we still can still have hope because PPHM management interest lines up with ours in one respect: They want to make as much money out of this (mess?)as possible just like us. Hopefully they lowered their expectations below astronomical just like we have done.The lower their expectations the better. It would mean a swifter action to resurrect the pps.
>You like the soothing words. Okay. By August, your 80K loss will evaporate and be replaced by a minimum 800K profit<.
It felt really good to read that at least for a few seconds until I read the rest. At this point, as a PPHM shareholder who is like a boxer with his eyes 98% shut after taking so many punches and who can't see where the next punch will come from I take anything that might make me feel better even if it's just for a few seconds.
It's definitely not JB.
There is no resemblance.
Agreed. They should have partnered long time ago. Phase II would have been a good time to partner. Look at VRTX as an example. They partnered early and their stock is trading at 86 with a market cap of 21 billions and EPS of -2.31?
As some on this board have stated you are not just going to walk in into the pharma industry and disrupt what BP has been trying to do for many years. PPHM got smacked down with a Phase II sabotage and now a very unusual dramatic out performance of the control arm. PPHM should by now, hopefully, realize that the only way to get anything out of this is to partner soon.
BP controls the FDA to some extent we just don't know how large. BP funds the FDA. That should say it all.
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html
>If they have a plan and can show that the Sunrise halt is not the end of the world then they need to tell us. If not and they want to remain quiet then someone needs to go.<
The always like to keep everything close to the vest. Remember many years ago they did not even have conference calls and had to be forced to have them. Now they take a few screened? questions on the conference calls.
I think the only hope we have at this point is that they are tired of postponing the big payoff just like the retail bagholders. They want to make as much money as possible but at some point you gotta take the best available deal. They just cannot have another round that will last another five, ten years or longer of trials, excitement about all the different possibilities, talk of partnerships that never come to fruition even at least one should have already according to King,s words.
You would think that they want a lot more than the overinflated salaries they are getting. The AbbVie deal fell through because of the sabotage. That was three years ago. At this point they need to think about sharing the potential big payoff with a BP that is willing to share the risk of failure.
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To repeat the obvious if Bavi is so promising, Peregrine should be able to get a favorable partnering deal. If they can't, very likely we amateurs are wrong about Bavi
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There was a 2 billion deal with AbbVie that was derailed by the sabotage. Does that prove that there will never be another deal?
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I'd rather see them lay off the entire development staff and make a profitable future from Avid.
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I think they are trying to get Sunrise approved which would explain why they are not laying off. Is that even possible? How many believed at that time that a failed or sabotaged phase II trial would be good enough to get you into the next phase?
If Bavi performed as expected in Sunrise according to King and then it can be proven that the dramatical outperformance of the control arm was a fluke and you compare Bavi's performance to the historical performance of Doce OR if it is found that there was interference in the control arm that led to its abnormal and unexpected performance then maybe Bavi might get approved. We just don't know.
The FDA, according to his mission statement "is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."
If the FDA follows his mission then it could conclude that Bavi is more efficient and safer than chemo and Opdivo with its 9 months OS which they are very proud of enough and was approved by the FDA because its control arm had only a 6 months OS. PPHM can then proceed with the commercialization of Bavi or sell it to BP for a huge chunk of money. BP can then choose to either sell Bavi+chemo and charge as much as they would with I/O drugs like Opdivo, shelf it and proceed with they new I/O drugs by themselves or add Bavi into the mix if it helps.
On the other hand, the FDA which is controlled by BP to some extent ( we don't know how large) might bow to BP and then Bavi is not approved. At this point, PPHM can let BP into the fold and see if Bavi can improve the efficacy and safety of I/O drugs like Opdivo. You only need one BP to do this. AZ please step up to the plate or the long suffering shareholders will lose big time. But PPHM management will lose the most because they have by far the most shares.
King is just an employee who gets his marching orders from ES. He is the one that what you said applies to. We know that they did accept a two billion deal from AbbVie before the phase II sabotage. So we never know when will strike a deal. But I think you are right in that they passed on many offers. King did say that they were in talks, a partnership was to come by a specified time frame but it never did.
There could also be a saboteur working at AVID. All this person had to do was apply for the right job at AVID to pull something off. It probably would have been easier for BP to do this than paying off JB and Finken or whatever his name is.
If the Bavi control arm got opdivo how can anyone take this phase III study seriously? If the FDA was truly a fair and impartial agency they would not have allowed that. Was this in the trial design? At the very least Bavi+ chemo should be compared to a clean chemo trial like the opdivo control arm.
failing to ink a deal in the relatively near future
I have never seen this discussed on this board. Maybe it has but I haven't seen it. A patent is for what? seventeen year? The longer they take to ink a money deal the less that patent is worth. There are some patent experts on this board. How many years on the Bavi viral patent left? Two? Six? Why would anyone pay PPHM anything now for Bavi viral when they can get it for free in a few years? Does anybody know how many years left on the Bavi cancer, oncology whatever you want to call it are left? Four, five, ten? If a BP gets the Bavi exclusivity it can only stop its competitors from using until the patent expires. Then Bavi will go generic and I if am correct it can be used by any doctor as he wishes for anything else once it has been approved by the FDA.
So you can expect to get a lot more on deal with fifteen years left on a patent as opposed to four years left on the same patent everything else being equal. Of course we now know much more about the efficacy and safety of Bavi then we did years ago but still if PPHM is back like they said on evaluating combinations of Bavi plus an I/O drug and then developing a plan or plans how many more years are we talking about before they are done with those two things? And how many years will be left on the Bavi cancer patent? If there are only two, three years isn't every thinking BP going to wait until the patent expires so they can get it for free or pay PPHM the peanuts that it will be worth then?
This is just like a out of the money stock call option. That option has some value even if it never is in the money (determined also by how much it is out of the money) but if the market price never changes the closer you get to the expiration date the less your option is worth. Let's say you can get $5 dollars if the option expires ten months later. You can expect to get much less when you are only one month from the expiration date and practically nothing the last week and nothing even if it were to reach the strike price when it expires.
How many are interested in doing the whole thing again with BETABODIES? The last time I checked you can expect to live what? 80 years? Twenty years of this is a good deal?
Great job by management with AVID. I think some may be underestimating what AVID alone can be worth in a few years. You can only wish that they had done a half way decent job monetizing Bavi. The last chapter on Bavi has not been written yet so we wait.
There can be no question that it was done deliberately. Whoever is behind this like the CA suit, the trial sabotage doesn't want PPHM to succeed. What I think is troubling is that someone is still out there attacking PPHM. We might feel that it is no possible to have another trial sabotage when the Sunrise trial is being done at so many different sites. What if they compromise the results of just one patient? How would that play out? It might not make a difference in the overall results but I think it can still do a lot of damage to the credibility of the entire trial. What safeguards are there this time that were not there during the phase II trial? The fact that you have so many sites now gives the enemy more targets.
After so many things that could have been pr'ed and never were you can definitely say that it is not expected.
Krakonos, a very interesting story of a man with a stage 4 cancer that had metastasized to his bones and would not submit to chemotherapy because it would damage his immune system. He decided to raise his PH to fight the cancer. He ended up using baking soda with molasses and was successful.
You can read it here about it and also about Dr. Sircus baking soda formula.
http://drleonardcoldwell.com/2013/11/01/stage-4-cancer-gone-with-baking-soda-treatment/comment-page-1/
The idea is to raise the PH which can be accomplished even without using baking soda. Sugar should be eliminated completely as it makes cancer thrive and lowers your PH probably more than anything else.
Other things you can try.
Alkalizing bath, alkalizing drink by Moreless who had over four hundred testimonials from people who had success with his protocols with many different conditions or illnesses. The idea is to raise your PH and neutralize the acid in your body. Your PH should be above 7 and never above 8 which can happen from taking baking soda for long enough. A PH above 8 is not good either. Your blood PH is always in a very tight range of around 7.4. Your body keeps it at 7.4 by buffering the acids with the calcium that it leaches from your bones when you are acidic. You can buy PH test strips at Amazon to test your PH.
ALKALIZING BATH FORMULA FOR CURING CANCER
Run a hot bath (as hot as you can personally stand).
To this add the following:
1-2 pounds of Epsom Salt
1/2 to 1 pound of Baking Soda
3-4 pints of Hydrogen peroxide
Soak in this bath for a period of time. Start out slow (i.e. 15 minutes). As your health improves you will be able to stay in them for much longer. If you are in ill health make sure there is someone you can call to help you if you feel to weak to get out of the bath or if you feel like passing out.
After the bath, finish by taking a cold shower. This is very important. Do not skip the cold shower step. Stay in the cold shower for a few minutes. Just long enough to cool down your entire body. MORELESS SAID LATER THAT YOU SHOULD END THE BATH WITH A WARM SHOWER
You can do these baths as often as you like. ----A friend of mine who used this protocol to cure himself of cancer did these baths as often as three times per day. Again start out slow, especially if you are very ill and make sure to always finish with a cold shower.
Evan,
http://sicknesshope.com/node/295
ALKALIZING DRINK FORMULA
ngredients:
1. 1 tablespoon of blackstrap molasses (it may be Unsulphured )
2. Juice of half a lemon (OR 1 tablespoon apple cider vinegar if you can't take citrus or get hold of lemons)
3. 1 + tablespoon pickling lime water (how to make pickling lime water : 1 tablespoon of pickling lime powder, aka calcium hydroxide, diluted in 1 gallon (=4 litre) of distilled water) *see safety notes below* (you add one table spoon of Ms Wages pickling lime to one gallon of water and then add one tablespoon of that to the drink)
4. Small pinch of Epsom salts
5. Norwegian kelp powder 1 + teaspoons ( we use Icelandic kelp tablets from Nature's life. My wife has taken as many as 8 tablets a day and it did get rid of her acne along with the alkalizing drink She will only take the calcium carbonate and magnesium oxide. Not time to explain why I think it worked now. The pickling lime and kelp powder are very very bitter.
http://www.amazon.com/Natures-Life-Tablets-Icelandic-Count/dp/B000I48OKG
6. 1 glass of clean water to mix it with
*** you can take a lot MORE pickling lime water and "Kelp"
than is suggested above. Start slow and if things don't
improve, slowly build up. Some of us use up to 20
tablespoons of pickling lime water and up to 2
tablespoons of kelp powder each time ***
http://www.curezone.org/forums/fm.asp?i=1019269
Moreless is or was very adamant about using pickling lime or Ms Wages pickling lime which is calcium hydroxide which has his detractors. It is used for making pickles which we eat and when I had my root canal done last year the entodontist packed my root with calcium hydroxide for about a month to kill the infection that had spread to my jawbone. So it can't be that UNSAFE. Moreless also prefers to get your magnesium from epsom salts. I have been using 1000 mg of calcium carbonate and 500 mg of magnesium citrate. I use powder which makes easier to change the amount.
A list of Moreless testimonials. He got even more of them on his site sickness hope. Can all those people be lying or wrong?
http://www.curezone.org/forums/fm.asp?i=1033906
what you are saying is really surprising. RS in eighteen months?
We will have the two lookins in less than a year.
If they are positive they will move the pps. We should have a deal if that happens. We saw the pps move north with the positive intermediate data in phase two. There was a deal that was pulled because of the sabotage. We can expect the same or even better pps appreciation if the first two lookins are good.
You will be right with bad data. With AZN and Sloan Kettering meddling in Bavi the chances are good that the data will be good.
Welcome to Peregrine Land where things always take a turn for the worse and the wait for the big pps rise continues.
You have now been officially PEREGRINED.
http://finance.yahoo.com/news/three-small-companies-big-name-161600972.html
CORAL GABLES, FL / ACCESSWIRE / December 1, 2015 / Over the last twelve months, many of the biggest players in biotech have inked partnerships or acquisitions to gain exposure to the immuno-oncology space, or stimulating the immune system to attack cancer. Pfizer Inc. (PFE), GlaxoSmithKline plc (GSK) and Celgene Corporation (CELG) have all committed significant capital this year. Analysts expect immuno-oncology to generate $35 billion sales before 2023, growing to account for 60% of the total cancer management space. The big names are not the only players, however. There are a number of smaller development stage biotechs with candidates in trials that could be the target of the next big acquisition deal, or become blockbuster therapies in their own right. Here's a look at three of them that already have big name partnerships.
Peregrine Pharmaceuticals and AstraZeneca
Peregrine's (PPHM) lead pipeline candidate is a monoclonal antibody called bavituximab. It is targeting an indication of non small cell lung cancer, or NSCLC. Healthy cells have molecules called phosphatidylserine lining the inside, or PS. These molecules are immunosuppressive, meaning they block the immune system from having an effect on the cell. This is one of the body's ways of defending its own cells against attack by the immune system.
In tumorous cells, these PS molecules turn from lining the inside of a cell to becoming expressed on the outside of the cell. The result is that the immune system won't attack the cancer cell. Bavituximab is a PS inhibitor.It binds to the PS molecules and hides them from the immune system, nullifying their immunosuppression. This opens up the pathway for a combination therapy to illicit an immune response.
The company scored a partnership with AstraZeneca PLC (AZN) earlier in the year to kick off a phase I clinical trial evaluating the combination of bavituximab and durvalumab with chemotherapy in multiple solid tumors, and announced an expansion of this partnership in October that will see a phase II global study of bavituximab in combination with AstraZeneca's durvalumab for an NSCLC indication.
Peregrine also has an ongoing phase III for an NSCLC indication, trialing its candidate in combination with Sanofi's (SNY) Doxetaxal. The trial should finish before the end of next year, so be on the lookout for interim updates. The next milestone will be the completion of enrolling set for this December. If we can get efficacy in any of the three mentioned trials, Peregrine could benefit from a quick upside revaluation. The company has had a tough year - down 33% on 2015 highs, and might be a cheap exposure to the space at current prices.
MabVax Therapeutics and Juno
MabVax Therapeutics Holdings, Inc. (MBVX) is a little behind Peregrine from a development perspective, but its candidates are no less exciting. Its lead is called HuMab 5B1, and the company is currently trialing the drug as both a therapeutic and an imagining agent in a metastatic pancreatic and colon cancer indication. The antibody targets colon and pancreatic cancer cells, tagging them for an immune response to that cell.
5B1 is exciting for two reasons. First, it addresses a therapeutic indication that has a large patient population. Pancreatic and colon cancers are very aggressive, and notoriously difficult to treat, and any entrant into the space has the potential to become a blockbuster. We have preclinical and anecdotal efficacy, with the anecdotal evidence deriving from 7 already treated patients vaccinated at the drug delivery stage, of which 6 are still alive. The company announced today that a new drug application has been filed, in order to begin a phase I trial early next year. MabVax also recently reported that it had completed the manufacture of the bulk requirements for the drug's trial.
Second, it has a potential indication as an imaging target. Because HuMab5B1 targets pancreatic cancer cells so selectively, it can be joined with a radioactive label and introduced into a patient, where it will target and highlight cancerous cells. Pancreatic cancer is very difficult to diagnose, and if MabVax can demonstrate the efficacy of HuMab as an imaging diagnostic, it could expose itself to a circa $450 million market.
Why is this important? Because it will be much easier for the company to achieve approval for an imaging agent than a cancer therapeutic.
MabVax's big name partnership is with Juno Therapeutics (JUNO), which has licensed 5B1 as a targeting sequence for its own engineered anti-cancer T-Cells. Any of Juno's product that goes to market with 5B1 as a targeting sequence will get MabVax a royalty.
MabVax is currently trading at a market capitalization of just $28 million - a 78% discount on annual highs.
CTI BioPharma Corp and Baxter
Finally, CTI BioPharma (CTIC). Those familiar with the immuno-oncology space will likely already be familiar with CTI and Baxter's (BAX) collaboration drug Pacritinib. For those not yet familiar, the drug is what's called a janus kinase, or JAK inhibitor, with an initial target indication of myelofibrosis - a rare form of blood cancer. JAK inhibitors, as their name suggests, work by inhibiting the function of janus kinases, a group of enzymes responsible for cytokine signal transduction.
Cytokines are a type protein that affect what a cell does, how it behaves, grows, replicates and when it dies. They bind to receptors on the cell and then use JAKs to signal the required action/instruction. JAK inhibitors stop the signaling, and in turn, stop cells replicating. The already approved Ruxolitinib is an example of this type of therapy.
CTI reported good phase III data back in May this year, with a primary endpoint of 35% spleen size reduction (a side effect of this type of blood cancer) met across a sample size of 327 patients. The two companies met with the FDA in September, and announced on September 23 that they would submit an NDA before the end of the year based primarily on data derived from the latest trial. The drug has accelerated approval designation, meaning if CTI can get its NDA accepted before 2016 kicks off, we could get a decision from the FDA during the second half of next year.
From a financial perspective, the implications of an approval far outweigh CTI's current market capitalization. The drug would be a direct competitor with Ruxolitinib, a drug that generates more than $500 million a year, $358 million in the US and $279 million internationally.
Near term catalysts are the NDA submission in the next few weeks, FDA acceptance of the NDA, the issuing of a PDUFA date and, of course, the FDA decision which should come towards the end of next year if all runs smoothly.
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Is this right?
Half way down, This sustained T-cell mediated killing of tumor cells is proving bavituximab produces an adaptive immunity not scene in PD-1, PD-L1 or CT-L4 agents.
Did you mean not seen?
Short selling maybe going on too. Naked is the worst.
People leave companies for different reasons. We don't know if she was forced out or fired. But at the very least it's good news that she picked PPHM when she could have picked some other company.
AbbVie likes deals where they pay money upfront and then down the road and is happy to split the profits. All of the prophets here who are voting yes on the new 175 million shares must have a lot of confidence that management will pull off an even better partnering deal by selling equity through a boatload of shares.
Or you can hold on or add assuring yourself of a seat on the plane if it should take off ahead of schedule.
I just hope I don't get bumped off due to overbooking.
Now that would be another nasty surprise a la botched trial.
Wonder how many brave companies would like to have CSM run their trials.
>CALICO gives us a Line of Credit for $2 Billion for expenses and R&D.
We give them 175 Million shares or 35% of total authorized shares<
What will that do the pps overall? Do we as shareholders see any pps appreciation?
Was there ever a deal like this would be deal, giving shares away at a superdepressed price? Or is the would be partner going to pay something like $10 per share?
What's wrong with a deal like all of the other conventional deals where the partners gives a few billions to this little puppy?
Wasn't AbbVie going to give 2 billions in the deal right before the botched trial?
Maybe the company is going to do with these shares the same thing they did before and are still doing? ATM spigot to raise cash to go it alone?
Didn't know they settled until today. On the one hand they settle for less than peanuts on a slam dunk and they they hold for years to get the best possible deal. Maybe they are trying to get this behind and felt that it wasn't worth spending any more time to get maybe a few more millions when you can spend all of your time and resources on getting a few more hundred millions by waiting it out and building value. Or maybe they are that inept. As usual, the retail shareholders at the bottom of the totem pole will always be the last ones to know and always the first ones to get screwed.
Every body seems to give too much credit to institutions. Who are these institutions, mutual funds? In that case all one would have to do put everything in mutual funds and you will get the best return for your money. Except that it has been said many times that mutual funds over all don't beat the market averages.
Which broker?
Scottrade and Merrill Edge don't allow you to short a stock under 5.
Are you retail or institutional?
Excellent post.
Many on this board have pointed that management is to blame for the miserable pps. How can you have small biotechs in phase II with a much less valuable pipeline cutting multi-billion dollars deals and have a much higher market cap that PPHM and not blame management at the same time?
Yes management should get praised for salvaging the botched phase II trial, the two recent collaborations that add much validation to Bavi, a phase III trial out of botched trial, AVID and the patents. But it all happened without any pps appreciation for which management is to blame. Management has scared off many would be investors and ticked off many shareholders some of which have been invested and investing for more than ten years. with a much less valuable pipeline
CALICO AbbVie Joint Venture
>cure for cancer? Forget it: Larry Page has something bigger in mind. Two years ago, unveiling its own biotech division, known as Calico, the Google chief executive said that ending cancer would only add three years to average life expectancy. How much better to tackle the diseases of ageing, which seriously erode the human lifespan.
Making a meaningful difference to health is one of Google’s biggest ambitions, and is an idea that permeates many of its investments. This has sent ripples of unease through the pharmaceuticals and healthcare industries, where Google has already forged partnerships, but is also seen as a long-term rival.
With Calico — short for the California Life Company — Google has reassembled some of the top talent from pioneering biotech company Genentech, including former chief executive Art Levinson. It has promised to put up to $750m into a joint venture of Calico and AbbVie.<
http://www.ft.com/intl/cms/s/0/1efc9ff4-4222-11e5-9abe-5b335da3a90e.html
Did AbbVie forget about Bavi or do they have a long memory?
Why can't they partner before Sunrise results? It can't be that complicated.
You pay a price for a phase III drug with no safety issues on track to be fully enrolled by the end of 2015. It's also very significant that the trial has not been stopped. You give it a probability of being accepted and you agree on a price before the results are known. Surely this has been done even for phase II drugs. Obviously, the price would be higher for the same drug when it makes to phase III and gets further into Phase III.
Then you agree on a price if bavi is approved. Obviously the price would go up if it is approved. If it is not approved the would be partner takes some kind of bath.
Or both parties agree on a final price before the results are known and make a deal. You also have the first and second look ins. The partner would pay more after a positive first look in. The partner would pay less if the partner made a deal before the first look in because it is assuming more risk.
The same kind of deal making would be used for a buyout.
Just make a deal. A lot of investors have been here for a looonggg time and are getting reallllly tired.
Make a deal.
No safety issues even when used in combination with chemo.
I don't know how much the chemo dose was or is reduced when combined with bavi. I remember the chemo dose reduced by 90%. Not sure if that is accurate.
I was here when this happened to PPHM.
Phase II to Phase III.
Up 200%. No PPS appreciation for PPHM though. It's because PPHM has been around for too long. Need parternship/approval.
http://finance.yahoo.com/q?s=itek
http://finance.yahoo.com/news/inotek-pharmaceuticals-announces-positive-end-110000277.html
That could have only happened through insider information which is illegal. Ask Martha Stewart. I think with the botched-sabotaged trial there would be some hesitation on trading on insider information. Even though the SEC and FDA are as crooked as they come (it's a revolving door between Big Pharma and Wall Street and both agencies) still you got to be afraid to pull the trigger because the SEC does nail some who break the rules.
So we still don't know whether there is a deal or not.
Look at all the biotechs that are now lined up to have CSM do their trials. CSM was a clear winner for sure.
What's even funnier is the AF was never short PPHM or worked for sharks who were or still are.