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I agree CP, it is not a scam when your drug, Bavituximab, is coursing through the veins of hundreds of patients all around the world.
The Sunrise first look-in gets closer every day. The survival data gets better every day. The good, we hope really good, news is building.
The scam is suggesting to the gullible that Pergrine/Bavi is a scam. Perfect company, not quite. But this is a serious attempt to crack into the oncology business with a significant new drug.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Meanwhile, another day begins with Sunrise patients living longer, we hope, with Bavi helping their immune systems fight cancer.
No Sunrise look-in PR today means the survival number clicked up another digit. Enough digits and Peregrine won't have to sell too many more shares.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
The problem is you can't trust what the BOD/management says let alone bank on what they are not saying
CP, I agree such a letter would be a good thing. Do not hold your breath.
Peregrine management clearly is in the "Just trust us" school of investor relations. Annoying. Until they change this mind set, here we are.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
jbainseky, one obvious reason to authorize millions of shares is to fund the company if something goes wrong with Sunrise. At that point PPHM stock will have crashed. If management wants to continue in business, they will have to sell millions of shares to do it.
I'm not saying Peregrine management knows anything bad about Sunrise. In fact they state in their SEC filing that everything is OK.
However, if they hit another iceberg like CSM, they will have a chance to stay afloat.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Pathetic how predictable things can be. Every time the share price dips we read:
The BOD is no good.
The management doesn't buy PPHM shares.
Ownership is diluted by uncaring management.
Bavi won't reach market until 2020.
Opdivo is better than Bavi.
Going it alone is madness.
When the share price goes up, we read:
How going it alone is brilliant.
How big our yachts will be.
How we'll all meet in Tahiti.
How smart we all were to buy at 10 cents a share.
How PPHM will reach $100 a share after two or three splits.
The simple fact IMO is Sunrise will deliver great results, the FDA will quickly approve, and the share price will rocket quickly to at least triple todays number. Maybe much higher.
Or, Sunrise will deliver less than great results, and we all made a big mistake speculating on Peregrine.
Fortunately we will soon know which way it plays out. Soon means by mid-March 2016 if not sooner, as I expect Sunrise second look-in data by that time. Just my guess.
GLTA, Especially Bavi-Arm Patients,
Paul
iii) there has not been any material adverse change in the business, properties, management, financial position, stockholders’ equity, or results of operations of the Company, taken as a whole; and (iv) the Company has not sustained any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor disturbance or dispute or any action, order or decree of any court or arbitrator or governmental or regulatory authority.
Any reassurance here?
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Once again, Peregrine management has found a way to scare the U NO What out of its shareholders. Obviously, they failed to foresee authorizing add'l shares would spook us. Maybe we should be spooked. Or maybe they should have been more upfront on the need to do this authorization now. Or postponed it until later.
IMO if Sunrise is a big success, the authorized shares won't matter. If Sunrise fails, the authorized shares won't matter to us, because we will all have bolted out the door as fast as we can.
Still positive, but just a bit more nervous.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Along4, the famous "soon" will be when Sunrise produces irrefutable proof that Bavi blows the SOC overall survival numbers out of the water. Say 50% or more increase.
From there everyone will know the FDA will approve quickly. Such quick approval should lead to significant dollar partnering and/or Peregrine announcing a credible distribution deal.
The first domino will be at the first or second Sunrise look-in. Somewhere between eight weeks and seven months by my crystal ball.
Of course, there may be a solid partnering deal at any time that would ruin my fearless prediction.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Sunrise first look-in another day closer.
Clearly, Peregrine management has bet the company on Bavi in general and Sunrise in particular. Based on their behavior I conclude they have little to no doubt Sunrise will succeed.
I am betting a nice pile of money they are right. We'll see in the next few months, maybe weeks.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Peregrine management. Many of us, including me, have long complained that management treats us like mushrooms, i.e. keeps us in the dark and feeds us manure.
I suppose the reason some us, including me, stick around is management's actions do speak volumes. They act as though Sunrise will be a great success. The new phase ii studies soon to be launched, the MSK contract to research Bavi and the anti-PS platform, Avid expansion, support of forums for the researchers in immune-oncology. The list goes on, and it is persuasive.
All of the above makes no sense unless management foresees major Sunrise success. We'll soon see how clear their crystal ball is.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Agreed, MazelMan. Peregrine has enough efforts going on that we should see something PR worthy before the Sunrise first look-in and the ASM.
GLTA, Especially Bavi-Arm Patients,
Paul
CsForH, my guestimates for the Sunrise look-ins were just based on:
1. Close to 500 patients would have been treated by the end of September of this year for the enrollment to be "on track".
2. Bavi-arm patients would survive 12 months to 7 months for the SOC patients, reflecting the numbers from the very similar Phase II Bavi study in NSCLC.
3. Review time by the Data Monitoring Committee would be two weeks. How much time do they need to review data that they are monitoring during the entire trial?
In the absence of any actual patient enrollment or ECOG data, just a guess. Actual results could be sooner or later.
Paul
Meanwhile Bavi continues to course through the veins of hundreds of Sunrise patients. The first look-in PR is now only two months away by my estimate. I hope we learn more than 'enrollment is on track for calendar year end'.
Of course, some of us hope for early trial halt for the humanitarian reason of giving Bavi to all trial participants. Don't know if this is possible.
We'll see.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
North, if my mid-October prediction for the Sunrise first look-in PR is correct, Peregrine management may want to share some info with us at the ASM. Wouldn't that be a welcome change?
Paul
CP, thanks for the update. Of course, Peregrine will succeed or fail long before batabodies make it to the clinics.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Silver lining? Probably not, but maybe Peregrine management will finally understand that informing shareholder aggressively might prevent the kind of SP slide we are currently enjoying.
Of course it is not much fun losing zillions of dollars on paper. I just have to remember to do some selling when/if we start making zillions of dollars on paper.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
PPF, your crystal ball is probably no clearer than anyone else's. We may drop more or we may bounce. Dead cat bounce or some other kind.
There will be no RS, unless the Sunrise results are as you say meh. I bet another bunch of cash yesterday that the results will mirror the Phase II results, i.e. blow past the SOC.
We'll soon see. My guess is mid-October for the first Sunrise look-in, mid-March for the second Sunrise look-in. If one of these is really good, buying at these scary low prices will be amply rewarded IMO.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Holy crap, geo. I think you have nailed the situation and the psychology.
Peregrine has always been risky. It is still risky, but the moment of truth is coming soon. Some checked their intestines and found the potential downside scared them more than the potential upside appealed to their greed. This moment of truth stuff is scary.
My intestines are too stupid to be afraid. So, I bought more yesterday.
GLTA, Especially Bavi-Arm Patients,
Paul
So, the share price tanked today, because Peregrine is using the ATM to finance the company? Like they have for the last 5+ years?
Paul
When the SP goes down without news, I like to add. 10k added today. New all time shares owned high.
GLTA, Especially Bavi-Arm Patients,
Paul
Paul, what data are you expecting in the next "few" months
tog, you won't have to grit you teeth too much longer. Sunrise and the other trials should produce data in a few months. At that point we can all relax. We will either make a pile of money or be out a pile of money. Simple, isn't it?
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Given overall results won't be known for a year - year and a half
Bavi has come a long way from the Tarvacin days. From what Dr. Thorpe's lab thought was a mab attacking tumor blood vessels all the way to Bavi's recognition as an upstream immune system therapy attacking multiple cancers. From Phase I's to Phase II's to Phase III.
Just weeks to months away from the moment of truth for Bavi and Peregrine. I know the market neither knows nor cares about any of this, but IMO they will.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Sunrise, the first look-in. If the trial is not halted to immediately put all the patients on Bavi, what kind of news can we expect from the Data Monitoring Committee and Peregrine management?
I don't know. I asked Peregrine IR through their "Contact Us" mechanism on their web site. No reply. Discouraging, but scarcely unexpected.
So, what might we learn.
First, it took X weeks before we hit 33% of total trial patients to event. How many Bavi-arm patients, how many SOC arm patients? Probably no data here. Presumably would disturb the double-blinding. Maybe not.
Second, we would learn about side affects. Based on prior trials probably not much new here.
Third, maybe detailed enrollment data. May not even get this.
While I am looking forward to this milestone in the trial, no real idea what we might actually learn.
Stay tuned,
GLTA, Especially Bavi-Arm Sunrise Trial Patients,
Paul
Correct, BioBS2012. Peregrine has said this frequently over the last few years.
Obviously, Peregrine management believes they can access an existing US distribution system for Bavi or create one of their own. I strongly suspect the former.
Do any of you know of a similar approach that worked well for a company like Peregrine?
GLTA, Especially Bavi-Arm Patients,
Paul
cheynew, it is painful to watch the share price slide. In the absence of news this is what we usually see, isn't it?
I like to think the Fargo Fiasco is the last piece of bad luck Peregrine is likely to endure.
Sunrise is approaching the look-ins. We will soon see this thing turn around for good, or we won't like what we see at all.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
MM, while I fully expect a PR from the first Sunrise look-in, I don't know that we can expect much information. The PR may only provide minimal data to avoid invalidating the double blind nature of the Sunrise trial. However, killer data that stops the trial for humanitarian reasons will truly move the dial on the PPHM share price.
GTLA, Especially Bavi-Arm Sunrise Patients,
Paul
Peregrine management and shareholders. In my countless years as a PPHM shareholder the only things I have heard from management regarding shareholders interest are a goal to minimize dilution and to build value by making progress in the labs and the clinics.
The strategy they have employed will prove itself or fail in the next few months. If Sunrise comes through with great survival numbers, we will be just fine. My money is still on PPHM.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
pdb, keep up the good work.
We wouldn't want anyone to expect the Phase III survival data would mirror the virtually identical Phase II study's survival data. Oh yes, this would be the data accepted by the FDA to green light the Phase III and Fast Track status. Of course, that can't mean anything to sophisticated clinicians like yourself. ROTFLMAO.
Good Luck to All, Especially Bavi-Arm Sunrise Patients,
Paul
MM, can't let it go so easily. Even if the look-in was not considered material, Shan said it would be PRed. I expect we'll get that PR within days, if not hours of the time Peregrine gets it.
We'll see.
GLTA, Especially Bavi-Arm Sunrise Patients.
Paul
BCS Paladin, agree to disagree.
IMHO and based on what management said, the first look-in will be PR-ed on a schedule dictated by the usual requirement for material events. This is about as material as material gets in my view.
We will soon see. By my guess mid-October if we have really good Bavi numbers. Guessing the date is hazardous due to the lack of enrollment data from Peregrine.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
CFH, you are very correct. When the "eventing" criteria is met the first look-in will be triggered, and Peregrine will PR it.
Can't say how much they will tell us, but the timing will give us a strong hint how much Bavi is extending survival.
Every day we don't get a PR means patients are living longer. Living longer with Bavi in their bodies. I like that a lot.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
exwannabe, I too have read the guidelines. In my view these are "guidelines" not rules or regulations. Following them is wise. Varying from them in a well thought out manner may well be possible IMO.
Or, as the guidelines suggested the DMC may halt the trial for safety reasons(unlikely in view of Bavi's low side affects history) or for humanitarian reasons.
This far into the trial we may be seeing Bavi-arm patients surviving well after non-Bavi-arm patients have expired. The numbers at this point may be equal to those in the Phase II trial that produced statistically meaningful results.
Who knows how this will play out? Or, how soon?
GTLA, Especially Bavi-arm Sunrise Patients,
Paul
exwannabe, as Peregrine has not chosen to share the instructions given to the Data Monitoring Committee(DMC), we can't know what the DMC will share with Peregrine.
We know the doctors and patients and potential patients must not learn anything that would affect the conduct of the trial. Does that me no sharing of data on the known number of evented patients with Peregrine management?
Of course, Peregrine may not be allowed to share what they learn with us. Or as seems often the case, they won't share even if they could.
Sadly, the wait from the 33 to 50% eventing thresholds will very likely not take more than three or four months. At that time I expect the Bavi arm patients will have survived so much longer than the other arm patients that the trial will be halted for humanitarian reasons. If this does occur, I like to think how the share price will respond.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
big, I have to disagree with your characterization of our beloved management figures. Just kidding. Their feeble efforts to keep us informed does not give me a warm and fuzzy feeling about them. A very big HOWEVER, they have relentlessly pushed Bavi as hard as possible since day one. I give them high marks for that.
The only real Bavi mistake I can point to is the choice to go after the viral targets first. Turns out cancer was a much better target. No way to know until you try.
My guesses on early look-ins for what they're worth - first mid-October, second mid-March. Either one could be the finish line in the sense that Peregrine will take off or sputter out. My money is on the take off scenario.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Geocappy1, you are right on point. Where is Peregrine today versus where it was in the past? We know the share price was much higher in the past. I can tell you as one who was there Peregrine is in a much more promising position today than it was at any time in the past.
The anti-PS potential of Bavi is much greater than any previous Peregrine initiative. The potential is much closer to actuality than any previous Peregrine initiative.
Anybody can spin the Peregrine situation any way they like, but they can't change these facts.
We are not at the finish line, but we can see it from here.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Another day closer to the Sunrise first look-in. Another day closer to Bavi's FDA approval. Another day closer to no longer hearing from DD, AF, CB and the rest.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Right on, Couch. All the negative vibes put out here will not amount to anything when Sunrise duplicates the great data from the virtually identical Phase II study.
We get closer to that point every day. My best guesses are first look-in mid-October followed by second in mid March next year. We may not need to wait that long for the train to start leaving the station.
All Aboard!
GLTA, Especially the Bavi-Arm Sunrise Patients,
Paul