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I bet nobody on the Wall Street has any idea who is on our BOD. I bet nobody on Wall Street has any idea what Bavi is. They will know what Bavi is, what Peregrine does and maybe even who is on the BOD when the Sunrise trial generates blow out numbers. If Sunrise doesn't deliver, Wall Street will never know Peregrine at all.
GLTA, Paul
It is apparent to me that no BP will offer a big money deal to Peregrine until Bavi has proven its value beyond reasonable doubt. I believe the Sunrise trial was designed to remove the doubt. Until then, I hope in the third calendar quarter of this year, we wait.
GLTA, Paul
Sunrise. Maybe the midyear look-in could produce statistically significant results meeting the studies goal of a 40% MOS increase.
The SOC produces a 7.8 months MOS. So, a 40% increase would be 11 months. Let's assume that like the Phase II trial 120 patients would be adequate to generate statistically valid results.
So, the question is when will 120 patients have been in trial for 11 months. The trial began in earnest with 25 sites open in May of 2014. By December of 2014 I believe there were around 100 sites open. How long did it take to get 120 patients enrolled? Don't know, but if we assume(always dangerous, but interesting) average enrollment per month during this May to December period was 60 sites with one patient every two months, that gets us 30 per month.
So, with this crude guestimate we have 120 patients by September to October. The eleven months from above takes us August to September of 2015. At this point the DMC might have the goods to go to the FDA for early approval.
I'm not saying this is the most likely case for how Sunrise is running or guaranteeing that the trial will produce the 40% MOS increase. However, the scenario seems as reasonable as those who blithely suggest no meaningful trial output until 2016.
GLTA, Paul
Verylong, you have your crystal ball, and I have mine. Time will tell who is paying attention to what.
I believe Garnick and company designed Sunrise to produce statistically rigorous data at the first look-in. Remember the Phase II had statistically valid data with a 120 patient trial. Sunrise plans to have 600 patients enrolled by this year's end. Remember also that the Sunrise trial's stated goal of increasing the MOS was very modest compared to the actual results of the Phase II. This reduced goal shortens the time required to complete the trial.
So, Sunrise may well have processed many more than 120 patients by mid 2015. Perhaps, a look-in around that time will trigger "something wonderful".
Focusing on what Peregrine did or did not do in the past may not be the best way to predict its future. The Peregrine that has relentlessly pushed Bavi to this point bears little resemblance to the Peregrine of years ago as I see it.
We'll see.
Veryfunny, verylong. The "botched" phase II results impressed the FDA enough to green light the Phase III Sunrise study.
In your view is the FDA "no one of importance"? Oh, by the way was the not-so-important FDA the entity that fast-tracked Bavi?
Some times I wonder about the things I read here.
GLTA, Paul
revenue_monster, it is different this year. In the past Peregrine had promise. This is the year it must deliver. If Sunrise delivers, Peregrine management will be in a position to create the shareholder value we have waited for. I think they will deliver either through a lucrative partnership or rapid commercialization of Bavi.
GLTA, Paul
pphmverylong, although no where near as long as me, I agree that the melanoma trial results will not significantly move the market. That said, if the results are great, the odds of a near-term partnership would increase dramatically.
As to what "the market" makes of Peregrine, I think it is clear to most who visit here that Peregrine is too far below the radar to be a known quantity.
You are certainly correct that it will take more than rumors to move the share price. I'm OK with that.
Meanwhile, the Sunrise Phase III trial is more than a year old and enrolling at more than 150 sites worldwide. My focus remains on this trial. When it produces news, the market will respond accordingly. Based on the Phase II NSCLC trial, there is strong reason to believe the news will be very good.
As to partnerships, you and I don't know what if anything is likely to happen. Not in the near or intermediate future. We know nothing substantial happened in the past. I think Peregrine's only valuable basis for a partnership is Bavi, and any deal made in the past would have undervalued Bavi's potential. So, any such deal would have been a bad one.
GLTA, Paul
While enrollment opened in January of 2014, I seem to recall there weren't many sites opened until May.
If patients were treated in January of last year, who knows how many have completed the initial four month or so cycle? I hope many patients are living better and longer with Bavi.
We'll see.
GLTA, Paul
itsabouttime, I agree completely. Of course, I do own more shares than I should.
There are several reasons to be optimistic about the Sunrise trial.
1. Rob Garnick picked 2nd line NSCLC as the most likely indication for success clinically and with the FDA.
2. The Phase II 2nd line NSCLC trial did have very promising results, despite the mislabeling by our cursed 3rd party contractor CSM.
3. The Sunrise trial is closely modeled after the Phase II trial.
4. Peregrine is throwing everything they've got into speeding up the trial. Numerous worldwide sites, site visits, etc.
5. Ten months since the sites opened and no show stopping problems.
So, will Sunrise succeed? My money says it will.
GLTA, Paul
geocappy1, no matter how you look at it, the Avid expansion is a very confident move by Peregrine. An aggressive move. Whether it means they expect to produce a lot of Bavi or lot of third party drugs or both, it shows the kind of confidence they can't put in a frothy PR.
GLTA, Paul
Nice to see the much-maligned Peregrine management is still pushing Sunrise. Approaching ten months since the first sites opened. Not much question that many patients have completed the initial treatment.
A little google research tells me the DMC won't stop the study due to good results unless the data is compelling and the chance of false positive results is remote.
As Peregrine negotiated the early look-in conditions with the FDA, I like to think Peregrine management hopes Sunrise can earn a chance at early approval by the FDA. Perhaps, this is why management has been so close-mouthed regarding the early look in terms. No point in raising our hopes and risking more lawsuits.
Maybe Bavi, Garnick and company we will give us an early look-in at Christmas this year. Ho!Ho!Ho!
GLTA, Paul
cjgaddy, I hope Mr. Hutchins can provide new information. I believe we saw similar data quite a while ago.
New news would be welcome.
GLTA, Paul
Once again based on my irrational IHUB Peregrine posting indicator, the SP will go up tomorrow. While the correlation between IHUB posting and the SP may be suspect, it is right occasionally.
GLTA, Paul
Fortunately, Sunrise may generate a look-in midyear. A partnership could come out of nowhere any time.
In any event the make or break news is coming in the next weeks or months, not years.
GLTA, Paul
I just hope March Madness 2015 is better than the last one for Peregrine. Lots of news, not much SP movement.
GLTA, Paul
We don't need no stinking betabodies!
Bavi is all we need to improve the SOC in multiple cancers without the usual toxicity of other treatments. At least that is what we hope will be the overwhelming concensus of the FDA and clinicians after they see Sunrise data. Too bad Peregrine management can't give us any idea how soon that might be.
The skeptics say we won't get any Sunrise data until 2016. The optimists say mid-2015. It would be nice if management could give us a better idea when the first look-in might happen and what might be revealed at that time.
GLTA, Paul
CSM question. Where are they getting the money to mount this legal defense? From a financial point of view did it ever make sense to duke this out in court versus settling?
For the conspiracy lovers. Is CSM getting financial support from some evil third party to fund this legal effort? If so, who is it?
GLTA, Paul
Goat, we need Sunrise to confirm Bavi/Peregrine's value. Fortunately, the much-maligned-here-management is pushing Sunrise as hard as they can - 153 worldwide sites, enrollment completion expected by year end.
When/if we see the kind of Sunrise data we have reason to expect, then we will see the share price move out of this 1 to 2 range. Won't that be nice.
GLTA, Paul
honestabe13, perhaps CSM will run out of money to pay lawyers and let their insurance company settle with us. The only ones profiting from this charade are the attorneys.
GLTA, Paul
CP, you are right to focus on the "secret records" at CSM. Why would anyone do what the CSM employee did? Even more, why would she keep records? I really don't get it.
Also, as you point out. Who discovered the records? When?
How could this go to trial? There is no way CSM comes out of this looking good. They have to settle or the judge may be even harsher than Peregrine.
GLTA, Paul
Thanks cheynew for the update. It seems like this process is taking forever, but if CSM can afford the lawyers maybe they can afford to pay Peregrine more than a few million dollars.
CSM must know they are going to lose. The longer we go into the process, the worse CSM looks. I can't believe their insurance company will let this go on much longer. If the Bleecker depositon next week is bad for CSM, we may get a settlement sooner rather than later.
GLTA, Paul
We must be due for another CC soon. Maybe Peregrine management will be in a more communicative mood.
GLTA, Paul
Meanwhile, another day, another new Sunrise patient. Every day we get closer to an early look-in. I wonder what they will see when they look in. I wonder what they will release to us from the look-in.
As usual the next few months will crawl by. The SP will be hit by bored sellers again and again. I hope Peregrine management can come up with a few snippets of good news to keep the SP afloat at the current price. If the snippets are good enough maybe we can float back up to 1.50.
As others have mentioned, our good fortune depends on Bavi helping patients. A win-win for them and us would be nice.
GLTA, Paul
edcpf, I agree. To complete enrollment by year's end Sunrise must be adding about 40 patients a month.
I like the aggressive schedule Peregrine has set. If they can get it done on time or early, I like our chance to see some early look-in data in mid-year.
GLTA, Paul
dia76ca, I agree you picked the operative sentence. Bavi changes the tumor environment to make other therapies more effective. No reason for anybody to sabotage Bavi. Bavi is everybody's friend.
GLTA, Paul
The move up today supports my thesis that "the market" has no idea what Peregrine is doing. Those of us who actually follow Peregrine know that this news isn't that new.
By extension I conclude the value "the market" puts on PPHM shares bears little relationship to its potential value.
I hope this potential value will appear this mid-year with stellar Sunrise data. If you'll forgive the pun.
GTLA, Pau
Sunrise guesses.
We might have enrolled 200 patients by now. More than the Phase II Second Line NSLC study's 120. At least we know the trial hasn't revealed dangerous toxicity in Bavi or the trial would have been halted. We had no reason to expect such toxicity, but it's good to know none has appeared.
About 100 patients may have completed the four month initial treatment. Initial patients are eight months into the trial.
In five more months the numbers will probably be 350 patients treated and 250 completed treatment. The 75 or so patients from the first three months of recruiting will be one year into the trial.
All the above numbers are guesses, but probably not too far off. I wonder if we hear anything mid year from the DMC or Peregrine management.
GLTA, Paul
Hypi, I can understand why you find the level of debt concerning. However, I believe you are wrong in suggesting that the world economy is a fragile thing because it is supported by a lot of debt.
The world economy in my limited understanding is supported by our shared confidence that human activity will keep the wheels of commerce spinning. Not a con game, but a confidence game. Fortunately for us the power of billions of humans believing in the financial system is a formidable stabilizing force.
The top level people in government and academia know the system is built on confidence. They will do their very best protect the credibility of the system. The recent near financial panic of 2007 is a prime example how an otherwise dysfunctional US government managed to bring us back from the brink.
Think about it. Spreading doubt about our confidence game could be considered treasonous to the entire human race.
I forgive you. LOL.
GLTA, Paul
Sunstar, I agree Garnick must have crafted the interactions with the FDA concerning Sunrise to give Bavi the best chance at approval, probably approval at the earliest possible date.
You have every right to approve of Peregrine management approach to handling information from the Sunrise trial.
However, isn't there always a however, as a PPHM investor who views the Sunrise trial as critical to Peregrine success I have a different point of view. I want Peregrine management to recognize its investors are keenly aware of Sunrise's importance, and accordingly provide the maximum information available consistent with fostering the trial's success.
Anything less than full disclosure of Sunrise trial progress fosters doubt and cynicism that drags the share price down.
I can't see why the FDA would object to more openness regarding trial progress. Outside of improbable, illegal activity I don't see how competitors can do anything to stop the Sunrise trial at this stage. I don't see what their motivation would be given Bavi's profile as a partner with other therapies, not a monotherapy.
GLTA, Paul
EBS, you may be right or you may be wrong about what the DMC will see in the first look-in around mid-2015.
First, we don't know how the enrollment is going, so we can't know how statistically significant any finding may be at that time.
Second, we can't know how many patients in the control arm have evented vs. the bavi arm. So, we can't know how much better the Bavi arm patients may be doing vs. the control arm.
So, the trial may indeed run into 2016 with no significant results or may be terminated in mid-2015. Either to request early approval or to shut it down as unsafe or ineffective.
Also, we can't know when/if Peregrine will finally get a partner, which would spare them the usual dilutive funding. So, your concern regarding funding could disappear at any time.
It is always safer to assume the worst case scenario. However, anyone who expects the worst case scenario would be nuts to buy PPHM shares IMO.
GLTA, Paul
Based on the previously identified correlation of massive posting here on Peregrine with share price movement, I predict a share price increase tomorrow.
I know not scientific, but the heart wants what it wants, right?
GTLA, Paul
Along4, the Peregrine Predicament. Sounds like a one of those adventure novels. Maybe like the Davinci Code.
We are all sick of the share price slide. Many of us are frustrated that management can't pull a rabbit out of its hat to give the market a reason to be patient.
However, Peregrine has no trouble funding operations, and it has a very promising Phase III trial well in progress. I can think of much worse predicaments.
GLTA, Paul
Amazing isn't it? How many years ago did we figure out that Cotara was going nowhere? Five, ten years.
During those long years with nothing to go on except Dr. Thorpe's lab work and a trickle of money from Avid, yet the share price was higher and many posters here more optimistic.
Now we are well into a very promising Phase III with Bavituximab. Bavi has always been in concept a much more versatile drug than Cotara without the scary radiation connection.
And yet, the share price sucks and sentiment here is all doom and gloom. Sad, huh?
We could really use some good news. A PR updating progress in the Sunrise trial would be nice.
GLTA, Paul
IFU, I don't believe management, even this tight-lipped management, would wait until December of this year to say they were significantly behind. They probably don't want to spend time on another class action lawsuit, which this would surely generate.
Whether Sunrise enrollment is ahead or behind schedule is purely guesswork at this time. As they ever quotable SherlockHolmes said, theorizing in the absence of facts is pointless.
Eight plus months since the first US Sunrise sites opened to patients might be a good time for some kind of update from management.
GTLA, Paul
Sunrise enrollment. We just don't know.
In the absence of news, people get bored and dump their shares. Doesn't necessarily mean anything about Sunrise enrollment. Even so, an update on the Surnise trial development might help slow or reverse the slide.
Come on Peregrine, throw us a bone.
GLTA, Paul
A really important word, Sunrise.
If Sunrise's bavi patients are living more than a little longer, we will be more than OK.
Good luck to those patients.
Paul
Guess some folks are running out of patience. Completely understandable. The minimalist communication approach of Peregrine management does not help in times like these.
OK, Peregrine give the doubters reason to believe you are creating value. Come up with something positive to say, preferably soon.
GLTA, Paul
If one is concerned about Peregrine's present or its future, it's all about Bavituximab and the Sunrise trial IMO.
We'll see in the next few months how this plays out. I like Peregrine's chances to succeed with Sunrise, and thereby make shareholders like me a nice profit.
GLTA, Paul
Stoneroad, if Bavi is the real deal, then Peregrine management is the real deal. Ducks or no ducks.
GLTA, Paul
Abe and Sulaco, Sunrise will tell the market, academia and us whether Bavituximab is the real deal. Fortunately, the wait for the answer will be in months, not years.
Until we have the results, the SP will hover at these levels IMO. I like our odds.
GLTA, Paul