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volgoat, the trial is blinded only in part.
The number of enrolled patients is not blinded or Peregrine could not have told us they 90% enrolled.
The number of "events" is not blinded or Peregrine could not guide us to the timing of the early look-ins.
Given the enrollment data, the eventing data and their Phase II experience in the second line NSCLC indication, I expect they have a good idea how the survival numbers have played out in the Bavi and non-Bavi arms.
My question remains, given what Peregrine management likely knows, do their actions indicate confidence in the Sunrise results or an effort to get Plan B going.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
While some like to sweat the timing details regarding when Sunrise enrolment is complete or what day a new trial starts, I am focused on the Sunrise results. Great results and we are off to the races. Less than great and we linger at current SP levels or worse.
Clearly no one here knows what data Sunrise will produce. However, I believe Peregrine management has a very good idea how good or bad the survival data will be. No mystery here; the trial has been running long enough for Peregrine to give guidance on the early look-ins, which are based on patient survival.
My question is can we tell from Peregrine management's latest activities whether the Sunrise survival data will be as good as we need it to be or not. Particularly the NCCN deal. Does this show confidence in the Sunrise results or resorting to a Plan B?
GLTA, Especially the Bavi-arm Sunrise Patients,
Paul
With the NCCN deal is Peregrine positioning the company to take advantage of a successful Sunrise trial? OR, is the deal how the company hopes to move forward after disappointing results?
I am betting on the former, because it will make many of us a big pile of money. I don't want to think about the latter for obvious reasons.
GLTA, Especially Those Critically Important Bavi-arm Sunrise Patients,
Paul
Despite all the negative noise here about how Peregrine management can't do anything right, the latest move to hire the NCCN to expand research on Bavituximab is exciting. To me this move says we know we have something valuable, and before we make any kind of deal we want to fully explore just how valuable it might be. I'm sure the BPs will not pay the kind of price we'd like, unless the return on investment is nailed down beyond reasonable doubt.
GLTA, Especially the Bavi-arm Sunrise Patients,
Paul
In true Peregrine fashion the share price went down last week for no apparent reason. Similarly, I expect the share price will go up for no apparent reason this week.
Just the usual 'Peregrine gets no respect oscillation' until incontrovertible proof of Bavi's value is published for all to see. Sometime in the next few months IMO.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
PVL, if Dr Thorpe, Rob Garnick, AstraZeneca, etc, etc, etc were/are correct about Bavituximab, this will be a very good year to own PPHM shares. As Sunrise enrollment has already reached the 90 plus percent level, Peregrine tells us to expect first and second early look-ins by mid 2016.
Maybe a BP will not want to wait on a major deal with Peregrine until that time, but by mid 2016 the opinions about Bavi-Peregrine will be replaced with the kind of data the FDA, BPs and the investing world will respect and act on.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Well, Hope. This could be the year that the Peregrine investors see some serious green. Sunrise will produce the data that makes or breaks the company IMO. I know there is a lot of other interesting stuff out there or in the works, but the Phase III Sunrise data could convince many players to get serious about Bavi-Peregrine. We will know this year, probably in the first half of the year.
GLTA, Especially the Bavi-arm Sunrise Patients,
Paul
2015 was a lousy year for the share price. You can analyze it any which way.
2016 will be great or even lousier than 2015. My money is on great.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Hi geocappy1,
Despite the rapidly approaching Sunrise Phase III early look-ins, Peregrine still gets no respect. If we optimists are correct about Bavi, the share price move will be delightful.
Thanks for your efforts to enlighten those who might be confused by the drivel we regularly see here.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Guaranteed success? No. Reasons to expect success? Yes. The nice thing is we will get a meaningful answer in a few months. Not a lot of months, not a lot of years.
After a very long process, Bavi has a chance to prove itself among the immunotherapy elite.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
A very Bavi Christmas to the Bavi-arm Sunrise patients! If Bavi works as we believe it does, and it has extended the lives of these patients, many of these folks are enjoying another Christmas with their families they did not expect.
Paul
My guess is a billion dollar partnership announcement. Don't you just love this guessing game?
GLTA, Especially Bavi-arm Sunrise patients,
Paul
So, the "dead money" people who bought shares of PPHM for under a dollar last month just turned a 25% profit. That's 12 times the return of a 10 year US Treasury.
Of course, if they were the kind of traders who talk down Peregrine to get a low purchase price, I do not wish them well.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
cjgaddy, I'm curious why the Avid question went to Rob Garnick. I thought his focus was on bringing Bavi to FDA approval. I wonder how closely linked are Avid expansion and FDA approval for Bavi. This is probably another signal that Peregrine management is extremely optimistic of FDA approval and Peregrine is seriously preparing to produce commercial quantities in the not-too-distant future.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
cjgaddy, thanks for setting the record straight. Not that it will have any impact on pvl.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Will the flight to quality, i.e. PPHM, continue on Friday? I think it will.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
The occasionally correct IHUB messaging barometer strongly indicates we will have a green day tomorrow.
GLTA, Especially the Bavi-arm Sunrise Patients,
Paul
When Sunrise gives us the solid numbers and MSK gives us their seal of approval, maybe then we will see the share price go to more comfortable levels. Unless of course a white knight BP sweeps Peregrine off her feet sooner.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Let's see.
Sunrise pushing past huge a milestone - full enrollment. Two interim looks and data unblinding in the coming year.
Avid making more money every quarter.
The no name management developing close ties with AstraZeneca.
The no name management expanding Bavi trials into breast cancer.
The no share owning management submitting Bavi to MSK examination.
$70 million in the bank with no debt.
Why would anyone want to risk an investment in such a company?
Maybe they think they will make a lot of money.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
md1225, I certainly hope you're right. In view of the conservative nature of BPs I do not expect a deal until the second look-in, which as SK said we can expect mid-2016.
I think the terms you are suggesting are too generous. I think you are probably tripling the deal, but even that would make many of us a lot of money.
GLTA, Especially the Bavi-arm Sunrise Patients,
Paul
Couch, based on the last CC, I sense management can predict Sunrise data they can take to the FDA. I like to think the BPs and the market will take Peregrine to a new level when they do.
We'll see.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
IMO the CC was extremely positive.
Management explicitly said the existing Sunrise enrollment will support both look-ins in the expected time frame. In this case whether enrollment is complete on December 20 or January 20 is simply not relevant to the success of the trial or even when we will see the early look-ins.
During the questions segment I got the impression the fear the Sunrise trial results could be skewed by unexpectedly long survival data in the SOC arm is not a problem. Two reasons for this. First, the possibility was anticipated and the trial structure to avoid such an outcome. And second, the Sunrise trial survival data as available to management shows no sign of the problem.
The new Phase II/III lung cancer trial with Atrazeneca will soon launch. In fact the groundwork has already been started with the best Sunrise researchers and sites to ensure a rapid enrollment period for the 200 patients.
The long wait for Peregrine to follow up on its earlier success in breast cancer is finally over. The results in Her2 negative patients in the earlier trial was very encouraging.
Avid is continuing to grow revenue rapidly. Additional Avid expansion is contemplated.
70 Million dollars in the kitty to fund the business.
In sum things are moving rapidly in the right direction.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
The CC was extremely positive for many reasons.
Sunrise on track to produce the both interim look-ins in the first half of 2016.
While continuing to push into lung cancer treatment with AstraZeneca, Peregrine is re-launching Bavi against breast cancer. Why now? IMO they always wanted to, but now they are so confident that they feel able to tackle another major effort.
Of course, Avid continues to accelerate earnings.
I found their response to the question they received on unusually good SOC arm data in connection with the Sunrise trial very interesting. While they clearly did not have a planned answer, it was clear that they were aware of the issue when they planned the trial, and I believe they suggested the trial results to-date have not caused them any concern on this matter. In my optimistic view this gives an early signal that the trial results are likely to support solid Sunrise results.
I'll sleep a little better tonight.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Couch, well said. The antiPS-bavituximab project has reached the critical stage - a pivotal Phase III trial. Not just reached the trial but is completing enrollment. AND, management has guided to two interim looks and data unblinding in the next year. "Soon" is almost here.
Obviously, Peregrine has greatly diluted early shareholder. I was such an early shareholder, but I liked Bavi's potential and added way too many shares over the years.
As they used to say "The End is Near". I am risking a lot on a Happy Ending.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Three weeks for Steve King to deliver on his estimate that the Sunrise trial will complete enrollment by December 31, 2015.
At that time he may be in a position to convey a sense of how well the trial is going. I hope he is and takes the opportunity to give his shareholders reason to expect good things in the next few months.
We'll soon see. For those who love to question how soon is soon that would be three weeks.
GLTA, Especially Those Bavi-arm Sunrise Patients,
Paul
We will soon see if Peregrine PRs the Sunrise enrollment completion. Then, we will see if the share price moves meaningfully as someone here suggested. Personally, I don't expect it. However, I would love to be surprised.
GLTA, Especially Those Bavi-arm Sunrise Patients,
Paul
Dead money until 2016! Yikes, we might have to wait four more weeks to get rich.
Kidding aside, if Bavi has the right stuff, it will be abundantly clear next year. Probably by mid year. Maybe sooner.
After all these year, hallelujah!
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Right on point, CP. Although many of us know Peregrine very well, why should the broader investing world see Peregrine as anything other than "just another tiny biotech with an idea that may or may not pan out"?
Peregrine will get its coming out party when Sunrise produces great data or when some BP determines they can make more money by partnering/buying Peregrine now than later. I have no idea when a BP might see enough data to make such a move.
The point is despite its years of struggling, Peregrine is still an unknown quantity to most investors. I hope to see this change in the next few months. Of course, some BP may not want to wait. Not saying the early move by a BP is likely, just a possibility that should be considered.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Less than four weeks till Steve King's predicted Sunrise Enrollment Completion. Not long after that for the first and second look-ins.
We should see the small melanoma trial Bavi-Yervoy results in a few weeks.
After all these years of watching the Bavi story from the Dr. Thorpe patent applications to Phase III testing. Peregrine is either going big or going home. And soon. Scary, isn't it?
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Sunrise:
Experimental: bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
So, at this point there are close to 300 Bavi-arm patients who have received or are receiving weekly Bavi treatment. I hope many of these patients have not progressed.
Just a few more months to learn if Bavi is the real deal in this deadly disease. I guestimate early April will give us our first look-in. The second two to three months later.
Waiting is the hardest part, but we longs ought to be used to it.
Paul
What does Peregrine know about the course of the Sunrise trial? And when did they learn it? Peregrine told us when enrollment will be complete, and they told us when to expect the first look-in. Admittedly, the latter probably involved a certain amount of extrapolation.
I think it is safe to say Peregrine is given the enrollment data.
I have to wonder if Peregrine is told the eventing numbers. This would be key information. As they tracked this data most of the events in the early months would be non-Bavi arm patients. When the base line monthly numbers started increasing, it would tell them the survival data of the Bavi arm patients. This information would permit Peregrine to estimate that first look-in period. It would also tell them whether to prepare for success or failure.
In my view this data would only be available in the last few months. Let's see what kind of posture Peregrine presents in the next days and weeks.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Well said, Threes. The outline for Peregrine success is very clear. The Phase II NSCLC trial, however damaged by the Fargo idiots, and the preclinical Bavi-immunotherapy work strongly support the scenario.
Sunrise and Bavi-Yervoy clinical trials should give the market proof that Peregrine holds valuable cards. So, in the first half of 2016 I expect to see the share price much higher than today.
When the efficacy data comes out of the Sunrise trial in mid-2016, I expect to see another bounce.
The next bounce could come from partner deal(s). With yet another bounce on FDA approval in early 2017?
None of the above is certain. However, this recent move could be the skeptical market buying into our story. Is the train finally leaving the station?
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
SK has repeatedly told us Sunrise is on track to complete enrollment by this calendar year's end. Of course, it really shouldn't matter whether it is two weeks early or two weeks late.
However, it may tell us something about SK if the announcement comes much before or after December 31. The wait on this red letter date is almost over.
GLTA, Especially Bavi-arm Sunrise Patients.
Paul
When Peregrine PRs the Sunrise enrollment completion, I hope they manage to add some idea when the first look-in is expected. If they could provide some reason to believe the Bavi-arm patients are doing well that would be a welcome bonus.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
As Bavi moves ever closer to FDA approval and commercial success, I think the time has come to dump the hopium and switch to expectium. Kind of like going from heroin to methadone. You won't get as high, but you feel good knowing you are going in the right direction.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Immuno-oncology seems to be a very strong wave. Peregrine is in a super position to ride it. We just need more Bavi clinical evidence to convince the BPs and the market. If the Bavi-Yervoy and Sunrise trials produce the data we expect, 2016 will be the year we stop hearing from the doubters. Won't that be sweet!
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Hi Sunstar. Based on Bavi's consistency between preclinical and clinical responses, we have strong reason to expect exciting numbers form Bavi-Yervoy.
This study could be the straw that breaks the backs of the doubters. Maybe then we can see a share price more to our liking.
Then, our "dead money" could come back to life long before PVL's very pessimistic timeline.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
PPHM, the flight to quality?
Of course, it is a flight to quality when you can buy a stock for a dollar share that has clear potential to go to 5 buck a share in less than a year. Maybe less than six months.
We are six weeks from full enrollment in the Sunrise trial. Don't know that this will boost the share price much, but I do know it means Sunrise is on schedule to produce data that could easily take us back to five bucks in 2016, maybe mid year.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
cjgaddy, I am very confident that Peregrine will not disappoint those of us crazy enough to walk this road with them. When the big news from Sunrise or a big money partnership is announced, we will see a multi-dollar move IMO. Too bad these penny moves frequently dissipate.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
goodplenty100, rather than brush off these negative types, we should encourage them to hang around. It will be fun to see them respond to the huge share price surge we can expect over the next few months.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul