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dia76ca, the language used by the MSK researcher lends credence to the Peregrine claim that anti-PS drugs like Bavi have a key role to play in the immune approach to oncology. If MSK proves this, the line of suitors at the door to Peregrine could get pretty long.
GLTA, Paul
Peregrine management does it again. Just when many can't stand the long wait for news, they come up with something really promising. It is not some sneaky manipulative thing IMO, although some probably think so. It is just the result of Peregrine employees working diligently to get Bavituximab to FDA approval and commercialization.
Will they succeed? Nothing is done till it's done, but I like how management has relentlessly pushed the process for the last four or five years.
One way or another we are approaching the point where success or failure will be clear. If success is apparent, shares bought at less than 1.50 will make a lot of money IMO.
GLTA, Paul
Up 5% on triple average volume. If we could get some follow up news next week, who knows how fast PPHM might run.
GLTA, Paul
This news dovetails perfectly with Sunday's webinar featuring MSK researchers.
Volume may precede price, but respectability precedes volume. So, the respectability that MSK confers may grow the volume, and the price will move up accordingly.
Good move by the much-maligned-here Peregrine management.
GLTA, Paul
Peregrine management continues to push Bavi's visibility with the webinar. I know we are suffering from the long wait for the Sunrise and Bavi-Yervoy trials, but clearly Peregrine is not sitting around waiting on these results.
Most of what Peregrine employees are doing is probably too mundane to be worth notice, but it is all the countless mundane details that are what make the big news events possible IMO.
Hang in there longs. We are close now. Close to what? We will see in the next weeks or at most months. The years of waiting are behind us. That is certain.
GLTA, Paul
You have a very good eye for the mistakes Peregrine made. I agree the Dios business was lame. If that is you think the Dios business was a true indication of Peregrine management character and ability to perform, I don't know why you are here.
Where we part company is that I think the Dios matter was an outlier. IMO it was a mistake that has no relevance to Bavi's effectiveness, Peregrine management's focus and ability to commercialize Bavi, or the likelihood that PPHM shares may greatly increase in value in the next few months.
GLTA, Paul
honestabe13, we know things are moving along at Peregrine, because we know they are honest people trying their best. I have followed the company for a lot of years, and I have no reason to doubt their sincerity. This does not mean the Sunrise trial is a sure thing. In my view it is a probable thing, but we have to wait for the hard data to prove its value.
DD on the other hand makes no effort to conceal his hyper negative attitude toward all things Peregrine. You might remember his assertions that Bavi was a placebo drug, the FDA would never greenlight a Bavi Phase III, etc.
Peregrine's saying Sunrise is on track agrees with the 160 open sites on clinicaltrials.gov. Anyone who doubts management's basic honesty should have evidence to support their claim not just a history of error-riddled opinions.
GLTA, Paul
Agreed, md1225. Unfortunately, while we wait for real news from the Sunrise Phase III or the Bavi-Yervoy trials, we will be treated to topics having little impact on Peregrine's future.
We all know things are moving along at Peregrine. Something newsworthy has to break soon IMO. We just have to hang in there.
GLTA, Paul
OK, Sunrise followers, what does Peregrine mean when they say enrollment is on track? The immediate answer is they project to have about 600 patients by the end of this calendar year.
Simple math might dictate enrollment rates with 160 sites are now peaking. Compared to a more consistent enrollment rate over the whole trial, this "backend loading" would delay the accumulation of "events" that would trigger an early look-in. However, maybe the calculation is not that simple. For instance, maybe older sites stopped enrolling after achieving some pre-defined target.
The enrollment pattern would give us an idea when the look-ins might occur. If the look-ins happen before or after our expectations, we may estimate how well Sunrise Bavi patients are doing.
I suppose no one outside Peregrine knows the answer. If anyone has a sense how this is likely to play out, please share your insight.
GLTA, Paul
Hi Goat, at a basis of 1.50, 5 bucks would be a nice little profit for me. If the share price moved higher, I would still have enough shares to enjoy the additional profits.
I'd like to think Peregrine will be worth billions, but you know what they say about a bird in the hand.
GLTA, Paul
CSM and CA lawsuits vs. Sunrise. Which is more significant?
The CA has been repeatedly defeated in court. A non-issue. Winning or losing would have little impact on Peregrine.
The CSM is at best worth a few millions dollars and a reputation restorative for Peregrine. At worst it was a waste of few million dollars in legal fees. Of course, for the conspiracy adherents a third party evil BP could be revealed, leading to some huge penalty payment to Peregrine. IMO after two plus years and millions of dollars of legal fees, if there ever was an evil BP, we will never know. Conclusion: the CSM lawsuit was a necessary action by Peregrine, but ultimately will have little effect.
A successful Sunrise trial could lead to series of events making Peregrine worth billions. Sunrise failure would crush the company. Summary, a hugely important trial.
Therefore, no contest. Sunrise is probably the only issue of real importance. Let's keep our eyes on this prize.
GLTA, Paul
Volgoat, if the share price reaches $5, I will sell a large fraction of my 70K shares.
GLTA, Paul
Interesting the lack of excitement here over Bavi. Every little thing that casts a shadow over Bavi's prospects seems to suck the enthusiasm out of this board.
Bavi's ability to aid in the fight against cancer is clearer now than any time in the past IMO. While new drugs are springing up all the time, they are not silver bullets. None that I've seen are.
If Bavi's promise in immuno-oncology is fulfilled, patients in several major cancers will be benefitting from it for years to come. Those of us who hang in there will be happy we did IMO.
Happy Sunday, Paul
bigbro1, good advice to Hypi. He/she doesn't like PPHM now. Why hang onto a stock you don't like?
I, on the other hand, really like PPHM now. Actually, more than in a long time. Of course, I liked it a lot in the fall of 2012.
Maybe fall of 2015 will be even better. Sunrise has the potential to take out those highs of 2012 in my view.
We'll see in the next few weeks/months.
GLTA, Paul
I remember the enthusiasm mounting back in 2012 as we waited and waited and waited for the survival data from the Bavi 2nd Line NSCLC Phase II trial. Sure enough when the data finally did emerge it was great.
As our wait for the first Sunrise look-in drags on, I like to think we will have great news like that from the Phase II, only this time without the CSM screw up.
Every day without the look-in data increases my optimism. Of course, the impatient types just keep dumping their shares. Maybe they will have reason to rue that call.
GLTA, Paul
Couch, I agree Sunrise data can take Peregrine to a new level in many ways. Good data should move the share price up sharply. If this is followed by a partnership or Peregrine management finds a viable way to make Bavi a commercial success, the share price will move even higher.
It has been a long, frustrating process as a Peregrine investor, but we will very soon know if we made a lucky wager or stupid mistake.
I keep hoping the first interim look provides efficacy data. I know we can't expect it, but we might be pleasantly surprised.
GLTA, Paul
EBS, there is a clear possibility of a first look in this quarter. It is event driven, and sadly the events must be nearing or may have already passed the trigger number.
As the Sunrise patients treated at this point may be two to three times as many as were treated in the Phase II's statistically significant trial, I believe there is a real chance that the trial may be stopped in this quarter for humanitarian reasons.
The time table sited in the CSM trial may have been exaggerated to emphasize the damage done to Peregrine. Would a lawyer exaggerate something to gain an advantage?
We'll see when the first interim look happens. I don't expect a trial halt for humanitarian reasons in this quarter, but I would not be shocked.
GLTA, Paul
Too bad we are so eager for Sunrise-Bavi information that we pounce on every little crumb of related data. Probably an unavoidable situation.
As to Brekken's comment regarding a 2016 look-in, I agree that he was more likely referring to unblinding of Sunrise data than the first look-in.
As to the fact that the DMC has not given the first interim report, I agree the likelihood is that the Bavi arm patients are living much longer than the other patients. The Phase II trial clearly predicted this, and incidentally Peregrine has bet the company's future on it.
GLTA, Paul
md1225, I'm afraid the rules governing the DMC may not permit release of data on Bavi's efficacy in the Sunrise interim report. If so, the first look-in may not produce a SP spike, unless the efficacy is so good the trial is halted to permit the control patients to receive Bavi treatment. This might be asking for too much. We'll see.
GLTA, Paul
CP et all, I sincerely hope Peregrine will be worth billions some day. Apparently that day is not in the immediate future.
GLTA, Paul
Geo, we live in frustrating times here on the Peregrine watch. So much we don't know.
What management has given us reason to believe is that Sunrise enrollment is proceeding as expected with completion this year. From this we can confidently expect the first look-in report any day.
What we can't know is what level of disclosure the DMC and Peregrine management will share with us. My guess we just get "enrollment continues on track' and no unexpected negative side effects have emerged. Anything beyond this will be a surprise. I suppose amazing results could halt the trial and set up early FDA approval. We will soon see.
As to the beta bodies, I see them too far down the road to have relevance.
GLTA, Paul
Meanwhile Sunrise continues to enroll and treat patients. Must be hundreds of patients by now.
I hope the interim report tells us something about efficacy. No reason to expect such detail as the DMC rules are meant to protect the integrity of the double blind protocol. Who knows maybe there is a way to share without compromising the trial.
At any rate the informed consensus is the report will come out soon. We could really use some good news.
GLTA, Paul
TOG, sadly I agree that those counting their millions while PPHM is still selling for pennies are kidding themselves.
However, your 5 cent drop on Monday is pure speculation. The blip on Friday might mean nothing or it might mean a nice little PR on Monday that takes us up a dime or so.
GTLA, Paul
volgoat, I think you might want to check the hopium levels in your bloodstream.
GLTA, Paul
As a shareholder, I love the conversation about how disappointed other shareholders will be to "only" get ten times their investments.
As I am currently slightly in the red, I would be ecstatic to sell for 5 to 10 times current prices.
Talk of share prices north of $10 seems amazingly premature. After we pass $2 or $3 maybe I'll start fantasizing about $10.
GLTA, Paul
CP, if I understand you correctly, you expect the Sunrise interim report will not show us anything we don't already know, unless the trial is stopped due to very good or very bad efficacy/safety numbers.
I tend to agree with you. However, Peregrine may have found a way for the DMC to provide some efficacy feedback without jeopardizing the double-blind trial's integrity.
We will soon see, won't we?
GLTA, Paul
Data Monitoring Committees(DMCs) apparently are given a set of operating instructions. The FDA has recommendations but no absolute rules for DMCs.
So, the question I have is what instructions the Sunrise DMC has been given.
I suppose those of you with good relations with CK could ask him to publish the instructions. Given Peregrine's reluctance to share I'm certain you won't get any help from CK, but it probably won't hurt to ask.
I focus on this, because what the DMC shares with Peregrine is set by these rules. They might permit broad disclosure of trial results or only share safety and enrollment data. It is hard to gauge one's expectations for the first look-in without understanding the rules.
GLTA, Paul
The spring just keeps getting wound tighter and tighter. When it finally snaps, IMO the movement up or down will be huge. Scary, isn't it?
We all know some kind of news is coming. Rather than a pool on share price movement, maybe we should have a pool when significant news will come out.
My guess is May 26, the day after the US Memorial Day. Sooner would be OK.
GLTA, Paul
md1225, the share price is what it is. There is no "should be" price.
If Peregrine/Bavi produces the numbers in the clinics that you and I expect, then we'll see about a better price. Until then, lay off the hopium.
GLTA, Paul
TOG, a simpler explanation is that Peregrine is working with dozens of researchers in the immune oncology space. Some of them are probably independent university types. Some are probably other pharmas.
We should soon learn if any of these produce anything. Given the dozens I expect Bavi will show promise in at least a few of them.
Enjoy the wait.
Paul
Wook, as you note JB has a Pharmacy Tech education. Not a nurse, not a doctor, not even a bachelor's degree. No offense to Pharmacy Tech's, but this is a paraprofessional level education.
CSM screwed up, no question. They should have had someone watching closely whatever she was supposed to do. They failed to do so. And, if Peregrine's assertion is correct, they covered up her adventure in clinical trials modification.
As I have often suggested, I don't see a conspiracy here. A poorly run company in CSM, yes. A dopey employee with inadequate supervision, yes. A conspiracy, probably not.
GLTA, Paul
Near term things to expect include:
Bavi-Yervoy data
Bavi-PD1 trial announcement
Sunrise Interim report.
Any one of the three would really be welcome soon.
GLTA, Pau
Agreed, BKT. We are in wait mode. The nice thing is that there will be something to see in the next days, weeks, months. Unlike the past where there was nothing significant on the horizon. Our horizon now features a Sunrise Phase III.
The virtually identical Phase II trial results, before the CSM errors came out, took us up over $4. Sunrise may exceed those results in a Phase III. If so, back over $4? Could be higher.
We'll just have to wait and see.
GLTA, Paul
mmignot, I base my more modest Peregrine price tag on Bavi's value as part of a cocktail approach to the SOC for multiple cancers.
My closest Bavi analogy is Avastin. How much would a BP purchase Avastin near the end of Phase III testing? I don't know, but I guess a few billion. So, my more modest value is 2-4 billion. Ten dollars a share?
Not much by uber optimist standards. Eight times current share price would make me very, very happy.
GLTA, Paul
geocappy1, I think we share the opinion that Peregrine-Bavi represent real value. I wish the uber optimists like you were right.
The BPs know of Peregrine-Bavi. I believe they have a very good idea what its market value was years ago, what it is now and what it might become.
If the uber valuations many have cited here for years were probable, many BPs could have bought Peregrine at an attractive discount to its expected value at a price Peregrine management and the vast majority of shareholders would have loved IMO.
The fact that the BPs did not pull the trigger is better explained IMO by a more modest valuation of Peregrine than the "they will sabotage the company", "they will circumvent the patents", "they will buy off the FDA" et cetera explanations.
The "more modest valuation" I have in mind is enough to turn a huge profit for anyone buying at the current SP.
We'll see,
Paul
geocappy, I have no love for BPs, or for any other big time corporation. With almost no exceptions they are only interested in satisfying their greedy shareholders, unlike the altruists who post here.
However, I think they can do the elementary math and conclude it is cheaper, safer and more lucrative to buy whatever they want from Peregrine. Partnering or buying the whole company would be easy for many BPs.
I just hope Sunrise and Bavi-Yervoy prompt the deal soon.
GLTA, Paul
The good thing about our current lowly status is we have a huge upside if Peregrine ever does deliver. I hope the Bavi-Yervoy and Sunrise trials move us up over $5 before year's end. Could be the hopium talking.
GLTA, Paul
The silence is deafening. Again. I know the share price is a real downer, as we used to say in the 70s, but there can be no doubt that Peregrine is close to the finish line.
The consensus is the Phase III Sunrise trial will soon yield an early look-in. I don't know how much the DMC will reveal to Peregrine or how much Peregrine will reveal to us.
Based on the virtually identical Phase II trial, we have reason to expect Sunrise will exceed the modest trial expectations for overall survival. So, if there is solid increase in patient survival times supported by compelling statistical validation, I think Peregrine will broadcast the news as loudly as they can. Perhaps even go to the FDA for expedited approval under the fast track rules.
We can't be sure this will happen, the trial and FDA protocols may not permit it. If it does, the noise level here will rupture some eardrums.
GLTA, Paul
Poor little Peregrine. Is there an Orphan Company status? Nobody seems to expect anything good will come from Peregrine.
I disagree with the skeptics. Having followed this "adventure" for fifteen year, I like to think my expectations of imminent success are realistic.
We will soon see who is right about Peregrine.
GLTA, Paul
Sunrise trial updated yesterday at clinicaltrials.gov. Looks like something was set back two months. I couldn't tell what.
At any rate I remember how the excitement built back in 2012 when we waited and waited for a MOS announcement. It doesn't look like we will see the same excitement in connection with the first interim look. Maybe we should. The longer it takes for the interim look, perhaps the longer bavi patients are surviving. Pessimists will of course say the delay is due to slow enrollment.
As usual, we will have to wait to find out.
GLTA, Paul