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Slevets I strongly agree that Peregrine management does not share as much information as they could. I don't like it, but as long as they move Bavi forward as fast as they can I can live with it.
GLTA, Paul
Slevets, welcome to our little obsession. I would not blame the BOD or SK for the lousy share price. Might as well blame a lousy stock market that won't pay for financial promise only financial performance.
If you and the rest of us are correct about the medical promise, the Sunrise Phase III trial will produce blowout numbers. The blowout numbers will show a path to partnership, Bavi commercialization and/or a buyout. Then, we can thank the BOD and SK for their brilliant leadership.
GLTA, Paul
If Peregrine management is judged by what they have achieved over the last few years, they deserve very high marks. Focusing on Bavi. Salvaging the NSCLC trial messed up by those idiots in Fargo. Expanding Avid. Moving Bavi strongly into the immune-oncology world. Funding through the convertible shares. Etc. Anyone who slams management ignores a very substantial record of accomplishment.
Of course, the solid negative fact they focus on is the lousy share price. Conceded, the share price sucks.
However, if the Sunrise trial, the Bavi-Yervoy trial, and other efforts are successful, the share price will come around one way or another. In fact those of us who buy at these prices could make a very large profit.
We will know in the next months, I'd guess six months, which way Peregrine will go. To the penthouse or the outhouse.
GLTA, Paul
What ever happened to the frequent comparisons of Bavi and Avastin? I guess Avastin is just so yesterday!
For that matter I wonder what happened to the anti-angiogenesis product we farmed out to Russia? Last we heard it was in Phase 1 over there. Probably ran out of rubles before they finished the job.
From the meaninglessness of the above I conclude forget Peregrine's past. There is a lot there, but it will have very little to do with Peregrine's success or lack of success with Bavi.
Keep your eyes on Sunrise, Bavi-Yervoy and everything else Bavi.
Good night all, Paul
Can't wait for the next bit of significant good news. The share price is so down the bounce on good news will be very strong in my view. Should make for a very nice profit for those who trade by purchasing in the 1.30s.
Meanwhile Sunrise and Bavi-Yeroy are moving along. At 158 Sunrise sites you have to believe the first look-in will be sooner than many expect. I won't say imminent, but soon.
GLTA, Paul
Love how Peregrine management continues to push the enrollment pedal to the metal for Sunrise. They have no way of knowing how the enrollment is going. So, it makes sense for them to keep pushing the process.
When will we see Sunrise news? No one knows. I like to think it will be much sooner than the '2016' people think.
GLTA especially Bavi Patients,
Paul
Jeff, some us are hybrid investors - long in general, but willing to do a little trading along the way. After following this stock for years, it's clear that sizeable drops are usually followed by sizeable moves back up.
Nice to make a little money while waiting for Peregrine to bring Bavi commercial or get bought for a nice gain. If bad things happen to Peregrine, at least my losses will be offset by the little profits made on these blips up and down.
Meanwhile, I really hope Bavi helps millions of people and makes us millions of dollars. Did I say that?
GLTA, Paul
Nothing funny about cancer. I hope Sunrise is putting smiles on hundreds of faces today.
GTLA, Paul
I added today. I hope to sell these share for a short term profit. I love when the share price goes down on what can only be good news. Call me contrary, but I have made a little money the last few times I tried this. Might take a few weeks, but I can wait.
Meanwhile Sunrise and Bavi-Yervoy continue to treat patients.
GLTA, Paul
Come on Sunrise! Another month of enrolling and treating patients. We need the blow out numbers the optimists expect. A nice little 50% increase in the MOS would probably move us out of the minor leagues.
GLTA, Paul
Geo, I am trying to adapt a more positive attitude. Accordingly, I try not to respond to the unfounded negative comments we see here. No matter how many times they are repeated.
Instead I like to remind any and all that the pivotal Sunrise trial is running according to Peregrine's plan. A plan that focuses the preponderance of the company's efforts on pushing Bavi to commercialization.
Sometimes I like to vary that approach with reference to the Bavi-Yervoy trial that could kick out data at any time, because it is an open label trial.
Meanwhile the liver, breast and other efforts due rate honorable mention.
Why risk antagonizing the PTB when a simple re-directing of attention to the very real progress Peregrine is making is probably a more effective response.
GLTA, Paul
Re-read JB's testimony. It doesn't explain anything. CSM was in charge of the labeling, and the labels did not consistently deliver the required dose to the correct patients. They were hired to do the job and they blew it.
I hope the court punishes CSM for dragging out this process when they are clearly at fault.
GLTA, Paul
It's easy to get bogged down in the details, but one thing is clear to me. If what JB testified is anywhere near correct, CSM and JB had no idea how to run a double-blind trial.
I believe she asserts that CSM or one of its subs communicated information to Peregrine that unblinded the study. Astonishing that any competent contractor could let such a thing happen. Did CSM know anything about running such a study?
JB then takes it upon herself to reblind(!) the study by changing what doses patients got. Again, how could any contractor permit its employee supporting a double-blind study even consider such a wacky idea?
I hate to think JB is basically telling the truth, but I'm afraid she is. If so, She is an idiot working for a company run by idiots.
If she is not telling the basic truth, this pathetic story should fall apart.
GLTA, Paul
I can't believe the idea that the DMC doesn't get Sunrise data until the conditions for the first look-in are met. If the patients immediately started experiencing dreadful problems, it seems incredible that the DMC would not be there to shut it down. Conversely, if the data was crystal clear, I cannot believe the DMB wouldn't know that. What, if anything, they could do with that information I have no idea.
In any event an on-track Sunrise should be heading toward the first look-in conditions before too long - six months at most by my estimate.
Meanwhile, that cursedly slow Bavi-Yervoy IST could produce data at any time even though enrollment is not complete. It is an open label trial, right?
We might not get the news we want in the next few months, but we will get pivotal news.
GLTA, Paul
The expected(?) liver PR on Monday will have to show us more than has previously released on this study to give us much of a pop in my admittedly optimistic POV.
As to Bavi-Yervoy and Sunrise, I am very eager for news.
GLTA, Paul
Wook, 62 Sunrise sites have been open 11 months. If it takes two months per site to get one client - no idea if this is too pessimistic or optimistic, we could have had 90 patients eight months ago.
Given the 90 patient assumpting, the data monitoring committee(DMC) already has a solid indication how the trial is going. If the trial is meeting the hoped for results, almost all of the non-bavi have evented. Almost all of the bavi arm patients are still alive.
If each month this hoped for trend persists, how long would it take for the DMC to conclude it unethical to withhold Bavi treatment from the non-Bavi patients?
We might get a surprise during the next few months.
GLTA, Paul
Suspicious. Of course, we are suspicious of anyone who claims to hear how a double blinded study is going. One little however, the trial has been running with 25 sites open for almost a year. Could be some folks who expected to "event" are still doing OK. I suppose that might generate a little optimism.
GLTA, Paul
Share price goes up tomorrow based on the admittedly irrational IHUB Peregrine posting indicator. If we go down on no news, might just have to add.
GLTA, Paul
Never want to see the SP drop. On the other hand, a trading opportunity could be brewing. I missed the last drop to 1.35 before the run up to 1.55. Let's see how this plays out.
GLTA, Paul
Two conferences this week. Maybe we end this week higher than last week.
Meanwhile, Sunrise continues enrolling and treating patients. Let's hope the Bavi arm patients are feeling much better.
I wish that Bavi-Yervoy trial could give us a strong interim report.
This patience thing is wearing me out.
GLTA, Paul
stoneroad, in my recent dream Bavi-Yervoy results triggered a buyout by Bristol Meyers.
Dream on.
GLTA, Paul
Paid supporter? When the Sunrise and Yervoy-Bavi trials bring in sterling results, I hope to be paid a lot.
GLTA, Paul
Fortunately, I rarely dream about things Peregrine. However, last night I dreamt we got interim results from the Yervoy-Bavi trial. They were so good BMY bought Peregrine for the poison pill price of $11. One man's dream, another man's nightmare.
GLTA, Paul
edcpf, what if the DMC notes that almost all the eventers are from the non-Bavi arm? Do they have to recommend switching all the patients to Bavi and unblinding the trial?
GLTA, Paul
Every week more patients treated with Bavi. Every day one day closer to the first Sunrise Interim Look-in.
I know it seems like watching paint dry, but we are approaching the kind of news that prompts the few analysts who follow Peregrine to predict $3.5 or $5 a share. I know many here turn up there nose at $5 a share, but that price would fund a nice little upgrade in my living standards. Not to mention convince my wife that I really am as smart as she thinks I am. Sweet.
GLTA, Paul
If Sunrise proves that Bavi adds 50% to the MOS of the 2nd Line NSCLC patients, I wonder if they are considering repeating the treatment once the disease starts to progress. Rinse and repeat. Buy the patients more months of life?
GLTA, Paul
Volgoat, I don't want to distract from today's abstracts. They look good, especially the part about tumors completely disappearing.
I eagerly follow every lab and clinic Bavi tidbit.
I just wonder that some think the people who run governments are any dumber than our neighbors. Every group has its idiots. If our government was routinely staffed and led by idiots, we wouldn't be the predominant nation on earth. Not saying much perhaps, but there it is.
If you listen to some of them instead going with the flow of opinion, who knows what you might think.
GLTA, Paul
At 200 events what might the Sunrise Data Monitoring Committee see? If the Phase II study's results are predictive, I think they will see a 50 increase in MOS for the eventers. Roughly 8 months for non-Bavi arm patient and 12 months for Bavi arm patient - a 50% increase in Bavi survival time.
As we are talking about 200 events, this is many more patients than the statistically significant Phase II study's 120 patients. What would the DMC recommend?
I don't know when we will see the first look-in, but I think it will be sometime in the second half of this year. I don't know that the results will be as good as above, but I don't think such results would be a surprise.
I know we've been saying "soon" forever. I know we've heard this will be a great year for Peregrine before.
Maybe soon will be soon. Maybe this will be a great year for Peregrine.
We'll see.
GLTA, Paul
Peregrine management said new Bavi plus other io drugs clinical trials are in preparation. Maybe the SP can get a jolt from the announcement. Any weakness in the SP could set up a nice trade on the new trial(s) announcement. Maybe the current detractors are trying to set this up. Hmmm.
GTLA, Paul
Volgoat, if you believe as I do that the Sunrise trial will clarify Bavi's value, then clearly we will know where Peregrine stands by the 2nd interim look at the latest. If Bavi has not clearly demonstrated is value at this point, I think the optimistic case will be crushed.
That 2nd look-in is supposed to be at the 50% event level. I assume average monthly recruiting of 30 in order to complete enrollment by the end of the 2015. With 8 months survival for non-bavi patients and 12 months survival for Bavi patients, I would estimate the 50 % event level could be reached at something like the below:
60 Non-bavi events by May 1 2015
30 per months from May 1 on, or 8 months for another 240 events.
So, by December 31, 2015 we may have reached 300 events and the 2nd interim look-in.
So, at that point - 9+ months from now, I think we will know exactly where we stand. Of course, events before this time may tell us which way this thing will go.
GLTA, Paul
Listening to the CC again I was struck by how often the term "statistically significant" was used. I'm not sure why they put so much emphasis on this, but clearly they think it's important.
As to the SP, we all want to see it leap back up. If it doesn't, another trading opportunity will tempt me.
GLTA, Paul
Right, jbainseky. While some like to complain about past Peregrine efforts that didn't pan out, we are perhaps five months away from the Surnise first interim look. If the Bavi arm is outperforming the non, who knows what may happen.
If the bavi-yervoy study produces a great increase in responders, who knows what may happen.
If some cash laden BP with a trickle in the pipeline decides to gobble up Peregrine, who knows what might happen.
Maybe nothing will happen. Maybe something will.
I like our odds.
GLTA, Paul
bidrite, I admit I hoped Peregrine would partner with some BP and have the funds to push Bavi aggressively. I still see that might happen.
However, I see clearly that Bavi is not a 'monogamous" partner. It will effectively combine with many different partners. How could Peregrine partner with one BP and still move Bavi into the SOC with drugs from multiple BPs? Isn't the latter the way to maximize profits and treat more patients?
Let's see if Sunrise and the other clinical efforts clarify the best path forward for Bavi and Peregrine.
GLTA, Paul
R-M, I heard that too. Even though the primary purpose of the first interim look is to determine safety, evidence for efficacy or lack of same should be there.
At this point we are talking about 200 "events". In the 200 the breakdown between Bavi and non-Bavi deaths may be striking. I certainly hope it will be striking.
What the DMC and Peregrine management and the FDA might make of this I don't know.
GLTA, Paul
TOG, sometimes on track to complete enrollment by calendar year end means just that. You can interpret it any other way you want.
For me the situation is simple. Either the Sunrise trial produces results that the FDA, the cancer treatment market, and the stock market like or it doesn't.
The exact date Sunrise results will come out is clearly debatable. The Phase II 2nd Line NSCLC trial results and the on-track Sunrise enrollment encourage me to believe the Sunrise results will be available late this year. No later than mid next year. My opinion, probably not yours.
GTLA, Paul
For the doubters at least Peregrine confirmed Sunrise enrollment completion is still on track for the calendar year end.
Management continues to dodge any question on the first interim look. I didn't get any vibe from them whether the date is sooner or later than we might expect.
One might think the Avid expansion at this time suggests Bavi might get approval sooner than some think. Nothing too substantial, but it does probably express their optimism on this.
GLTA, Paul
Maybe Bavi's nature as part of a cocktail therapy makes Peregrine ill-suited as a partner with any one BP.
Maybe it makes more financial sense for Peregrine to mabufacture and sell Bavi to hospitals, clinics, doctors etc who can use it in combination with many different drug partners.
GLTA, Paul
After the last CC, the share price did NOT go down. Just saying.
GTLA, Paul
Sorry, Hypi. I just find the focus on King's presentation skills tedious, because I don't believe serious investors or potential partners put any stock in them. I believe their focus is on how they can use what Peregrine has to make money.
GLTA, Paul
Hypi, your complaint about the 40 slides reminds me of the Austrian Emperor who complained that Mozart's compositions had too many notes. LOL.
I hope Peregrine management saved some new information to share with us tomorrow. Maybe they'll even be more slides. Woo hoo!
GLTA, Paul