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Interim results, not this year.
You may be right. You may be wrong. Neither you nor anyone else here knows, because we don't have detailed enrollment information.
If you want credibility, you won't get it this way.
Personally, I expect first and possibly second look-ins this year with stellar results. But without detailed enrollment numbers, there is no way to be sure.
Meanwhile, Peregrine may be sitting in an immuuno-oncology sweet spot. The Bavi-Yervoy trial, which management suggests will have data this year, is testing this hypothesis. Strong results form this small trial data could get a virtuous cycle going.
We'll see this year.
GLTA, Paul
wook, I certainly hope Sunrise enrolls ahead of schedule. On the other hand I hope the first look-in doesn't occur too soon for the benefit of the patients as well as us longs. The more Bavi extends their lives, the happier we all will be.
Whatever language Peregrine management used, they clearly indicated they know enough about enrollment to expect(a forwarding looking word indeed) completion by year's end. So, they know something about Sunrise's status.
As we approach the latter stage of the enrollment period, I'm sure all who are interested in Peregrine would love to know as much as possible about the trial's progress.
Have a great weekend, Paul
What will come first - the next conference call(CC) or first Sunrise interim look-in? As we are twisting in the wind waiting for some inkling how Sunrise is doing, I expect the CC will come first. Might be wrong, but the guesses posted here lead me to believe the first look-in could be one to three months away.
What can Peregrine share about Sunrise at the CC? What will Peregrine know about Sunrise at that time? Yes, we all know this is a double blind study. However, Peregrine knew enough to say the enrolment was on track a few weeks ago. So, they know something about the trial's progress.
I think the above are good questions. Any answers out there? I hope the analysts at the next CC can get some "color" on this critical trial's status.
GLTA, Paul
Of course, CSM would love to limit their liability, while Peregrine would love to extract as much compensation from the company that cost them and us so much pain.
Meanwhile, let's keep our eyes on the prize. Blow out numbers from the Sunrise study should take us a long way toward Bavi commercialization, lucrative partnering or a profitable buyout.
At this time the CSM and CA lawsuits are footnotes in our story.
GLTA, Paul
While I am obsessing about Peregrine credibility and information sharing(or more accurately information not shared), why hasn't Peregrine been more forthcoming about the "dozens of collaborations"?
I do not doubt that there are such collaborations. However, if Peregrine is willing to announce proudly that such activities are in process, shouldn't it follow up with some details. If it doesn't, the credibility of the announcement becomes suspect.
There are always reasons to suppress some details, but there is a credibility issue if you release no details. At a CC they could note the number of university labs involved without naming names. They could mention the number of studies involving cancer vaccines without naming names. They could mention when any results might be expected. Etc....
In summary there are any number of things Peregrine could share with the world on these collaborations that would cause no harm and give their credibility a much needed boost.
GLTA, Paul
CP et all, as Sunrise enrollment numbers are publicly available in Europe, doesn't it make you wonder why Peregrine thinks they can't share enrollment numbers with us?
If you want to get an earful from Peregrine IR, just ask them about this. I suspect they believe there is some corporate benefit to withholding such information. Whatever benefits they might achieve with this approach IMO is vastly offset by the loss in investor and potential partner credibility.
If Peregrine is more concerned about investor lawsuits than meeting the legitimate information needs of its shareholders, they shouldn't be surprised at the poor share price.
I think Peregrine management has done a great job in general, but this 'treat em like mushrooms' approach rankles.
GLTA, Paul
Whoever has a sympathetic ear at IR, maybe you could ask what kind of Sunrise information Peregrine will be able to share with us at the next CC. We all know its a double-blinded study, and Peregrine has limited information. However, it probably has some information on how the trial is progressing.
In view of the critical importance of this trial, I hope that Peregrine understands shareholders legitimate interest in knowing whatever can be shared about it without jeopardizing the trial.
GLTA, Paul
Sunrise will produce both early look-ins this year in my view. The Bavi-Yervoy trial should produce data this year also. This data will make or break Peregrine.
So, after fifteen years of owning this stock through some good, but mainly bad, times, I will finally know whether I have wasted a lot of time, money and emotion on it.
One way or another Peregrine floats or sinks by Christmas, hopefully much sooner. My money says we finish the year above $5.
GLTA, Paul
bcs paladin, you are correct it is all about the money. Well, maybe cancer patients are more interested in living longer, healthier lives. But for now let's focus on the money.
How much more money might Peregrine shares be worth if Sunrise shows great efficacy? Don't know now. We will know before the end of the year IMO.
How much money might Peregrine sell for if Sunrise shows great numbers? Don't know now. We can expect it would be enough to make many of us 100s of Ks.
How much money might partners offer Peregrine if the Bavi-Yervoy trial shows doubles or triples the percentage of patients who respond to treatment, as one Peregrine researcher suggested? Don't know. Could be a lot.
It is mostly about the money. We will know in a few months whether it is flowing to us or away from us.
GLTA, Paul
bcs paladin, slight correction. The DMC knows in some detail and Peregrine management has some idea how Sunrise is doing. This helps us not at all, because neither of the them is talking to us.
GLTA, Paul
Thank goodness we will have a conference call in about a month. Perhaps Peregrine management will break with tradition and give us some idea how Sunrise is doing.
I know the trial is double-blinded, but I suspect management now knows when the first look-in will occur and when the DMC will report to them.
If we don't have a look-in by the next CC, I see no advantage the company gets by failing to share their expectations for the date.
I hate to see board members get so emotional about these look-in date predictions. Just too many unknowns.
GLTA, especially Bavi patients,
Paul
CP, I don't know anything about clinical trial enrollment patterns. I'm not sure how one could even research the topic.
I suppose someone who has good relations with Peregrine IR could ask for some guidance on what they expected to see.
The scenario of gradually increasing enrollment is consistent with the fact that we don't have a look-in announcement yet. If the announcement comes later because Bavi patients are doing so well, I would welcome that.
As long as Peregrine confirms the trial is on track, I don't see that we have any reason to be concerned about the timing of the first look-in. An early announcement would be bad, and every day that passes just makes me more optimistic.
GLTA, Paul
CP, we may not have seen a Sunrise first look-in, because the actual enrolment rate is only now reaching maximum. Perhaps the current enrollment rate is 40 patients per month. So, 40 X 6 give us 240 more patients to enroll by years end. Or, Sunrise may have enrolled only 340 patient.
In the 600 patient scenario with slower enrolment during the first 12 months, we would not hit the 7 month non-bavi, 12 month bavi eventing marks for about two more months.
GLTA, Paul
lemmy, it's not tweets we need. It's time. We need about two more months of Sunrise patient experience; followed by about one month of Data Monitoring Committee activity. My guess is the data at that time would give the Bavi arm 11 month survival with 7 for the non-Bavi arm.
Would this data be enough to halt the test? Don't know. Will they share such data with us? Don't know.
If we don't have a first look-in from Sunrise by then, my guess is that Bavi is doing very well indeed. That might be the time to consider adding.
GLTA, Paul
Why Peregrine will make us all rich. Not a question.
Dr. Thorpe's "lucky" discovery of the anti-PS platform.
Steve King's recognition of the potential of the anti-PS platform.
Steve King and the Board's decisive move to bet the company on Bavituximab.
Steve King and the Board's decisive move to invest in Avid.
Dr. Garnick's knowhow to take Bavi through the clinic to the FDA.
Peregrine's "lucky" arrival just as the immune-oncology wave is gathering speed.
Peregrine management creativity in raising money through the unloved ATM and preferred shares.
Add the above up and the total looks very promising to me. Anyone can nitpick at the path Peregrine took to get here. The only important things now are where we are and where we going in the next few months. The worst is behind us. Let's see how high this Peregrine can fly.
Sorry too much hopium in my coffee.
GLTA, Paul
Peregrine sure must be a wonderful company to have investors who hold their shares so tenaciously even though they think its management is lousy and its only potential source of profits is of dubious value and won't complete its stage three clinical trial for years.
GLTA, Paul
I know that Sunrise is a double-blinded study. Very rigorous. However, I wonder if the clinicians running the study communicate with Peregrine some sense of how things are going. I know the doctors don't know who got Bavi and who didn't.
Maybe the doctors can report on side effects reported or patient mortality. Just curious.
GLTA, Paul
Predict the first look-in announcement date.
Based on my assumption that Sunrise will enroll 600 patients by Dec. 31 of this year and the current rate is 40 per month, my guestimate is some day between September 1 and September 15, 2015.
Unless Peregrine has crafted instructions for the Data Monitoring Committee otherwise or the data is overwhelmingly positive, I don't think we will get the kind of data we'd like to see. However, I think the odds of overwhelmingly positive data are better than 50-50.
So, we'll see in about three months.
GLTA, Paul
Not long enough, comparing the small study in pancreatic cancer, a notoriously fast killer, to the Sunrise trial is indeed ridiculous. I suspect you know better.
Not only are pancreatic and lung cancers very different beasts, but the Sunrise trial is by design almost identical to the Phase II trial that generated great survival data for the 3 mg. Bavi arm patients.
We will soon see who knows better about Sunrise, Bavi and Peregrine.
GLTA, Paul
Sunrise, another week without a first look-in. While waiting is painful, it is better for the patients and our ultimate financial well-being if we don't see the look-in for a few more months.
I know months is not soon. However, the longer patients live, the happier they and their families are.
The Bavi arm patients could live twice as long as the SOC patients. If Bavi can get close to this metric, we will leave this sub-$2 purgatory permanently IMO. That would be worth waiting a few months, wouldn't it?
GTLA, Paul
EBS, at the 33% event point 200 patients have expired. At the 50% point, 300 have expired. So, the gap between first and second look-ins is 100 events.
Assuming a monthly enrollment rate of 30, at this latter stage of the trial, about 15 non-Bavi patients are expiring every month. Sadly, at least 5 more Bavi arm patients are dying. So, in five months we go from look-in one to two.
Any problems with my math?
GLTA, Paul
Calculating the date of the Sunrise first look-in may be trickier than you think. It could be that the first six months enrollment was predictably slower than the balance of the trial. So, it may be a few more months before the 33% eventing. Especially, if the Bavi arm patients enjoy longer life as we longs expect.
We'll just have to wait a little while longer for that first look-in. I hope the numbers will be compelling enough to share with us.
GLTA, Paul
Couch, those of us who actual own PPHM shares will be very glad we do some day in the next few months IMO. Those who don't think this is a good idea are entitled to their soon-to-be-proven-wrong opinions.
Keep smiling, Paul
Just love how Peregrine management has dived into the immuno-oncology end of the pool. They are promoting bavituximab more aggressively than I ever could have believed. MSK research on anti-PS, opdivo-bavi and bavi-yervoy trials, Avid expansion to accommodate potential early bavi approval, etc.
I like how this is going, and I think longs may just make enough money to compensate us for reading all the negative stuff here over the last x years.
GLTA, Paul
IFU, Sunrise enrollment. The best information source we have on this is Peregrine management. They've told us that enrollment is on track for completion by Dec. 31, 2015.
How soon we get a look-in depends on the enrollment pattern. On this we have been told nothing. Could be enrollment starts slowly and builds smoothly. Could be enrollment quickly reaches maximum and gradually tapers. Could be different in different countries or different clinics. No real data except the above from Peregrine.
In my estimation Sunrise has completed treating at least double the patients of the Phase II study. I believe the data monitoring committee, DMC, knows how well the trial is going. We don't know what rules the DMC operates under. So, we don't what they may share with us at the first look-in. We can hope that given great data they can communicate this to us.
I don't know when to expect the first look-in, but the longer we wait, the better the data will be IMO.
GLTA, Paul
ku, I'll see your "reality check", and raise you one blank check. Maybe you're right. Maybe Peregrine is going nowhere.
Or, maybe the Bavi-Yervoy trial will generate scary good numbers.
Or, maybe the Memorial Sloan Kettering researchers did know what they were doing when they signed on to do anti-PS, i.e. Bavi, research.
Or, maybe the hugely important Phase III Sunrise trial will generate blockbuster numbers.
Or, maybe a partner will emerge tomorrow.
Or, who knows.
We'll see.
GLTA, Paul
To maintain our recent upward momentum, we need more good news. Surprise me, Peregrine. Throw a little gasoline on this fire.
GLTA, Paul
Very, I'm afraid you might be accused of a selective memory.
There was a huge run up in PPHM share price when the Phase II NSCLC trial continued running long enough to ignite speculation that blowout medium overall survival(MOS) could be coming. And sure enough, when the MOS was finally announced, the share price rocketed even higher. Sadly those idiots at CSM in Fargo screwed us.
The longer we go without a Sunrise look-in, the more likely we will see a repeat of that share price surge. Only this time there is no CSM to screw us. And, we are pushing through Phase III not Phase II. This move could dwarf the earlier one.
Should this happy scenario unfold, many of us will make a delightful, in some cases life-changing, profit.
GLTA, Paul
Another week without a Sunrise first look-in. Spin it however you like, but to me it means patients are benefiting from Bavituximab.
If this continues, we will all benefit from PPHM ownership.
Not the same old Peregrine. A truly laughable assertion.
GLTA, Paul
Next quarterly conference call coming up soon?
Paul
very, since you coined a login eerily similar to my own, I have often read your posts. It was immediately clear to me that you did not share my optimistic view of the company's prospects.
This has concerned me, because I did not want readers to conclude that I had changed my Peregrine opinion, which is more positive now than ever before.
So readers do not confuse our divergent opinions, and since I have been on the board many years before your arrival, I suggest you consider adopting a new login.
TIA, Paul
biopharm, some times a cigar is just a cigar. I see no need to find complex reasons why PPHM shares are so cheap. I see very solid reasons to expect this to change in the not too distant future.
IMO there is not much market interest in a little research biotech like Peregrine. So, the share price just floats around between 1-2. Only major developments like blockbuster clinical results or lucrative partnerships will move us out of this range.
Fortunately, I think we can see one or both of these events in the next few months.
GLTA, Paul
Couch, I sure do wish we had an ETA on those Sunrise results.
GLTA, Paul
PPHM and BMY sitting in a tree, m-e-r-g-i-n-g. First comes collaboration, then comes partnership, then comes merger.
The announced trial plan with Opdivo is an amazing achievement for AF's favorite placebo.
Let's hope the budding romance between PPHM and BMY leads to a walk down the merger aisle with a happy ever after ending.
GLTA, Paul
Lucky Peregrine. I know it didn't seem that way in September of 2013 when those geniuses at CSM in Fargo screwed up the some of the patient dosing in the Phase II NSCLC study. But look at the rest of what happened to Peregrine over the last five or so years.
All the brilliant work that went into Cotara and other promising therapies failed to achieve commercial status. Just when all was going south Peregrine signs up Phil Thorpe. Dr. Thorpe researches the hot new topic of anti-angiogenesis and comes up with a way to target tumor vasculature. The idea was to create a mab that would a) attach to tumors and b) carry with it a cancer fighting drug.
Amazingly enough the target on the tumor vasculature was PS. It turned out that this target wasn't just in the tumor vasculature, but in cancerous cells in general.
Then, amazing on amazing, it turns out that the mab, which was meant as just a way to deliver a cancer fighting drug to the tumor, was able to unshackle the immune system which was misdirected by the exposed PS .
Here we are years later in the thick of the immune-oncology wave attacking cancers.
An amazing lucky story. From the brink of disaster to the brink of big time success IMO.
GLTA, Paul
Futility? I think not. While many things about the Sunrise Phase III trial are not known. We may be able to rule out the "futility" case.
Given the "on track" enrollment, if the Bavi arm was no better than the non-Bavi arm, we probably would have hit the 33% evented mark months ago. In other words we would have already had the first look-in, and we would not have liked it.
GLTA, Paul
Very, you don't seem very optimistic. You and I can't know what the short term future holds for Peregrine. We can't know whether Peregrine will partner soon or not at all. A too good to turn down offer could appear any day.
Buck up, chum.
GLTA, Paul
Hypi, the share price and executive options are unrelated IMO. Management rewards themselves with generous options every year. As the share price has gone no where during this R and D phase, these options have no value.
However, when Bavi is commercialized or Peregrine is bought, their annual mountain of options will be worth a fortune. We, and they, will both benefit.
GLTA, Paul
After all this attention Peregrine has generated, I wonder if we see any move up tomorrow.
News from the Sunrise or Babi-Yervoy trials would be very welcome next week. We'll see.
GLTA, Paul
More posts today than on most weekdays. Not only that but the usual detractors are not trying very hard to refocus our attention on unimportant topics.
I can't wait to hear what comes out of tomorrow's webinar.
GLTA, Paul