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Sunrise is coming. At least I sure hope Sunrise is coming. Another month clicks by. Hundreds of patients with Bavi in their bloodstreams.
Obviously the share price reflects nothing good coming. So, if something good does come, the price action could be explosive.
Maybe we'll see in about ten weeks when the first look-in PRs in my estimation.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Bungler, I agree completely the Phase II has little to do with the current PPHM share price.
My assessment FWIW is that "the market" has no interest in promising little money burners like Peregrine until they see the money coming in exceeding the money going out.
Give Peregrine a few more months and I think "the market" will see the money coming. Only then will we see the share price make the kind of move we have been waiting for all these years.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
It will soon be time. You may be right that we are 6-8 months away from a big share price move. However, it may only be ten weeks away from a big move. I believe there is an excellent chance we will get the first look-in PR in mid-October.
Of course, we can't know what they will show us then. However, there is some chance that the pattern of "eventing" will clearly show that Bavi is markedly extending the lives of patients. If that does happen, we could see some really exciting things.
At any rate we might not have to wait much longer to see if our time has come.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
md1225, please tell your anonymous source to give us some details or spare us his unsubstantiated blather.
GTLA, Especially Bavi-arm Sunrise Patients,
Paul
hutschi, exciting to know that Bavi is in hundreds of Sunrise patients. The Peregrine inflection point is in sight. I hope for a first look-in trial halting for humanitarian reasons in mid October to put all the trial subjects on Bavi. Even this skeptical market would have to respond to such an event IMO.
If we don't get a halt at the second look-in, my guess March, 2016, I will be concerned. If Bavi performs as expected in this patient group, the efficacy should be abundantly clear by this point.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Sunrise first look-in. Since we don't know the Data Monitoring Committee's(DMC) operating instructions from Peregrine, it's probably premature to get excited over this. Of course, if the trial is halted for efficacy, that would be exciting.
Meanwhile my latest back of the envelope estimates are first look-in PR October 15, second look-in PR March 15.
Based on 7 mos survival for non-Bavi patients and 12 mos for Bavi arm. Also, assuming average monthly enrollment for eight 2014 months of 25 patients and average monthly enrollment of 35 for 2015 patients.
Just a guess.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Agreed, CP. Other than health the only way King turns over the wheel is to a new owner. Sale at this stage seems very unlikely. Once Sunrise is unblinded we could see a deal.
My only complaint with King is his inattention to shareholder need for information. Call it handholding or call it shoring up support, but Peregrine clearly takes us for granted.
GLTA, Especially Bavi-Arm Sunrise Patients,
Paul
Despite the inexorable(I hope) movement to Sunrise success, the share price will go no where until we see some news.
Too bad Peregrine management can't find a way to keep the pot boiling with a steady stream of news. I suppose it really is more important that they keep the pedal to the metal on moving Bavi toward FDA approval and major commercial success.
Meanwhile we longs have to endure the drum beat on contrarian stuff and a weak SP.
I am here till we get real news. Not a very enjoyable ride at this stage. I hope the reward will more than compensate us for our patience.
GLTA, Especially Bavi-arm Sunrise Patients.
Paul
CP, my research on DMC's suggests the data released at these interim reports is governed by written instructions from Peregrine. The only instruction in this regard by the FDA is the data released should not compromise the double-blind nature of the trial.
My question to Peregrine IR, so far unanswered, was what kind of information could be released as part of an interim report. I suppose it could vary quite a bit. From gross enrollment data to enrollment data by region to who knows what.
I don't see what harm could be done by Peregrine sharing something regarding these DMC guidelines.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
thealias2002, the question I posed to IR was what kind of information we could expect at the Sunrise first look-in. They could be as detailed as they felt comfortable with.
The point is they made no reply at all. Why have a "Contact us" mechanism if they have no intention to respond. Not so much as a thank you for your interest. That would not have made me happy, but it would have made me happier than no response at all.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
geo, certainly agree that CEOs are not expected to field questions from shareholders on a routine basis.
However, when you put a "Contact US' email area on you company website, anyone who sends a reasonable question should get a reasonable reply. I'm still waiting.
GLTA, Paul
md1225 agree with most of your points with two noteworthy exceptions.
The first look-in has not happened. I am astonished that you could think otherwise. Even Peregrine management has acknowledged that this is material and must be PRed.
Another point. The idea that Memorial Sloan Kettering would supply financing for a Peregrine effort is just weird.
I do agree 1000% that Peregrine management gets very poor marks for informing shareholders. If I didn't have such strong expectations for Bavi success, I would have dumped their stock a long time ago.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Talk about a dull board. From the lack of energy here you'd think nothing was going on. Far from it. There really is a lot going on; it just isn't where we can see it.
A hugely important, but double-blinded trial. By its nature not something easy to learn anything about. Good or bad.
Exciting Bavi-ipilimumab trial for melanoma. No word from this ISP.
Dozens of collaborations for Bavi and other treatments. No news here.
New trials for NSCLC and breast cancer launching soon.
So, lots going on. Just no updates from any for a while.
The bad part, any news lull exposes how little day to day interest Peregrine can generate.
The good part, if Bavi does come through, the action could get very brisk based on previous PPHM reaction to even modest good news.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Peregrine Investor Relations. I guess CK was not the only reason Peregrine IR has not been responsive to shareholder questions. Two or three days ago I used the "Contact Us" email feature at Peregrine's web site to ask what kind of information we could expect from the Data Monitoring Committee at the first look-in.
Not so much as an automated "Thank You for your interest" note.
I guess the more things change ...
Meanwhile, I hope the Bavi-Arm Sunrise patients are doing better than an expected.
Paul
Couch, I agree completely. After Dr. Thorpe identified Bavi as the anti-PS mab of choice, Peregrine has wagered the company on its success. Sunrise is the go big or go home effort for Peregrine.
Based on everything we know to date about Bavi, chances of major success are very promising.
We'll soon see which way this goes. To the Moon or the toilet.
GLTA, Especially the Bavi-arm Sunrise Patients,
Paul
tradero, what makes "sense" to me is that when each site came on line, they already had at least one patient. That would modify the spreadsheet version somewhat.
What makes sense to me is that the earliest sites opened were probably those expected to be the most productive. So the "every four months" between patients for all sites might skew the data in the wrong direction.
What makes sense to me is that five or six months ago Peregrine couldn't claim the enrollment was 'on track' with the slow initial enrollment schedule of this simulation.
In view of the absence of any quantifiable guidance from Peregrine, I can't put much faith in any of these simulations.
I whole heartedly agree the first look-in hasn't happened.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Tradero, beautiful job. I don't see any reason to buy your every four months assumption, but it might be right.
I also note that the three of the monthly enrollment increases in 2015 look lighter than the previous months? Feb-March, March-April, and June-July.
The October time frame may be right, but based on faster enrollment assumptions would reflect much better survival numbers.
Thanks for your effort.
GLTA, Especially Bavi-Arm Sunrise Patients.
Paul
Sunrise. Sunrise. Sunrise. All the rest is meaningless. If Sunrise delivers, we are set. If it doesn't, we're sunk.
We'll see in a few more months at most which way this shakes out.
GLTA, Especially Bavi-arm Sunrise Patitents,
Paul
Happy days for the complainers. Good for them.
However, every day hundreds of Sunrise patients are living longer due to Bavi in their bloodstreams. At least we hope they are.
If this Phase III trial results equal or exceed, as some expect, the virtually identical Phase II, we longs will have our happy days. Happy all the way to the bank days.
GLTA, Especially Bavi-arm Sunrise Patients,
Paul
Share price down today. Any reason to believe the movement is related to whether Peregrine-Bavi will succeed or fail?
No.
GLTA, Especially Bavi-arm Sunrise patients,
Paul
I wonder if the Sunrise Bavi-arm patients are seeing another sunrise because of Bavi. I hope so, and I hope they see many more sunrises.
Meanwhile the SP stinks. Maybe that will change in the next few weeks or months.
We'll see.
GLTA, especially the Bavi-arm Sunrise patients,
Paul
I thought I'd test the email option on the Peregrine website. Just asked if management could share with us what kind of information we can expect from the first look-in.
No answer yet. Maybe tomorrow. I'll keep you all posted.
Sunrise trial. Another day without a first look-in PR. Bavi treated patients living longer. Very cool.
GLTA, especially the Bavi-arm Sunrise patients,
Paul
The first look-in did not happen yet. Let me count the ways:
1. Management told us they would announce it. They haven't.
2. At last week's CC Shan told us the look-ins are event driven. Why do you think he told us that? Duh, because they haven't happened yet.
3. IMO there is no doubt these look-ins are material events. They must be reported timely by SEC rules.
The nice things about the certainty, in my mind, that the look-in hasn't happened is patients are living longer and Bavi's chances for FDA approval grow every day.
Speculation the first look-in already happened makes no sense.
GLTA, Paul
MazelMan, funny how PVL only mentioned stopping Sunrise for a negative reason. Shocking how he failed to mention it might be stopped for the humanitarian purpose of treating all of the patients with Bavi. Shocking.
Has to remind one of Casablanca's Louie who is shocked to find out gambling was taking place in Rick's Café.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Thanks, golfho. Obviously, you put a lot of time and effort into your simulations. I suppose the conclusion they suggest is the first look-in could be any time between now and the end of the year. I suspect closer to now than year's end.
By the way I broke 80 on two different courses on consecutive days. I guess focusing on that short game pays off.
Back to Peregrine. I sincerely wish management could find a way to communicate more detail about the Sunrise study, the 'dozens of collaborations', any serious partnering discussions, etc. They just don't want to share.
I know many of us grudgingly accept this attitude in view of our confidence in Bavi's odds of success, as we assess them. It doesn't mean we have to like it.
Thanks again for your efforts,
Paul
Very, I guess we differ on the importance of partnering at this stage.
Some think partnering will benefit shareholders in the short, medium or long term. Others think partners will prefer looking after their own interests rather than the existing shareholders.
Personally, at this stage I trust Peregrine management to look after shareholders interest more than potential partners will.
Once Bavi applies for FDA approval, then we will see whether potential partners are willing to pay a price I like. Until then I am content to trust management vs. your nameless would-be partners and their unspecified partnering offer.
GLTA, especially the Bavi-arm Sunrise patients,
Paul
Partnering point. At the CC King repeated that management is looking to partner Bavi ex-US. Why would they continue this approach if they had any doubt about Bavi's likelihood of success? Answer, they are more confident than ever in Bavi's future.
If they had doubts about Bavi, why limit the cash they could get by selling the partnering rights only ex-US?
GLTA, especially the Bavi-arm Sunrise patients,
Paul
ritualrain10, love your optimism. Of course, I share it. No chance the first look-in happened already. Peregrine management said they identify this as something they feel required to report.
That said, I did find the tone and content of the CC extremely positive. They may be wrong, but they are in the best possible position to know how well things are going.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Good news from the CC. Those whose criticism of Peregrine is focused on the share price, a valid thing, must believe the CC was good news because the share price has gone up since the CC.
As one looking for a strong positive uptrend, I will be watching next week with my rose-colored glasses on. If the share price continues to rise, I will begin to hope for the same kind of move we saw just before the Bavi Phase II NSCLC trial announced survival data.
I know some attributed that rise to potential partnering. I believe that's probably wrong. We didn't even know there were serious partnering talks until many months later as part of the CSM lawsuit discovery process.
So, we wait and see. Unless the Sunrise patients are that much healthier than the previous study, we should get our first look-in PR in a month or so. Sadly, we can't know how much may be revealed at that time without seeing the Data Monitoring Committee's instructions.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Sunrise is definitely running at full speed now. Otherwise, management could not expect enrollment completion by Dec. 31, 2015.
So, no matter how we guestimate, we know the first look-in is soon. I think we can refine that "soon" a bit based on the CC. If management could predict the first look-in in a few weeks, I think they might have said something. So, my refined soon is not before August 15.
I wish we knew what the Data Monitoring Committee's instructions were. If they can't share much, we likely won't know much more after the look-in than we did before. If they can share and the data is very good, we could reach that $5 price quickly.
Investing in PPHM is not for the nervous.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Geo, I believe that we could have reached the 190 events by now if the early enrollment was 30 or more per month. The fact that we have not received a PR leads me to suggest the early months of the Sunrise trial may have started slowly. This seems likely. There were fewer sites at first, and the procedures to get them running could have taken some time.
Consider the following rough numbers.
We are 15 months or so since the first sites opened, I believe it was May 2014.
So, given six months before eventing for non-Bavi arm patients, about 9 months of these patients would have expired by now - 9 X 15 = 135 events.
If Bavi arm patients are eventing after 11 months that would 4 X 15 or 60 events.
135 + 60 or 195. So, if the early enrollment rate was robust, I guestimate that we would hit the first look-in criteria by now or very shortly.
So, the only factors that spring to mind to explain the lack of a first look-in PR are slow initial enrollment and longer survival for patients, probably Bavi-arm patients.
Paul
In the absence of great news the SP will probably drift down from here. However, if the SP should start creeping up, I think a long powerful positive trend could take us well above where we are today. We'll see.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Hate to disagree, but I think we haven't had a first look-in for two reasons. First, early enrollment was expectedly slow. It has sped up and is now projected to conclude on time at the end of calendar 2015. Second, Bavi-arm patients are enjoying longer life as we had reason to expect.
My guess is the first look-in will be in the August-October range. Unlike you I expect the PR will follow in a few days, maybe two weeks. Not that hard to collate the reports the Data Monitoring Committee receives on a regular basis. Not that hard to send 160 emails out to request detailed confirmation. Not that hard for the 160 sites to check events it the handful of patients at each site.
I'll be very surprised if we don't have the first look-in PR by November 1. Any delay after that would suggest to me that early enrollment was very slow and the Bavi patients are doing incredibly well.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Not Frustrated.Sunrise is on track to complete enrollment on time. Obviously, the only really important fact we needed to hear at the CC. Many of us expect major success from Sunrise. Now we know there will be no delay in the trial. Very cool.
The much-maligned Peregrine management is expanding Avid to accommodate ever growing business. More business means more money means less dilution. Sounds like good news.
Peregrine is expanding late phase clinical trial in lung and breast cancer. Obviously management believes the potential value well exceeds the cost. Sounds like more good news.
Memorial Sloan Kettering taking on a paid research deal with Peregrine. Gee, probably the most famous cancer research institute in the United States. How much more good news could we ask for.
Chris Keenan is gone. I wish him well, but did not find him at all friendly.
The share price does suck, but the movement in company fundamental processes looks more promising than any time in Peregrine history.
GLTA, especially Bavi-arm Sunrise patients.
Paul
CP, did you notice King is still talking about partnering ex-US? I know many are probably disappointed with this approach.
It does tell me a.) Peregrine management really does expect Bavi commercialization and b.) Peregrine management has detailed plans to launch Bavi in the US to capture maximum profits.
A third conclusion might be that any buyer who wants inside US rights is going to have pay top dollar for them.
While the doubters will be back in full force over the next weeks and months, I am more confident than ever that we are heading in the right direction. We just need Sunrise data to leave the doubters in our rear view mirrors.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Wasn't it interesting management reported the Sunrise trial doctors are upbeat about Bavi. They quickly clarified that their optimism had nothing to do with the actual conduct of the trial. Of course, they couldn't say much about what they are hearing about the trial. This might in some way prejudice the course of the trial. Still interesting that the trial doctors, who are blinded, have this positive vibe about Bavi.
Given that the trial enrollment is on schedule, and given that we haven't got a first look-in, we might start to sense that the eventing is running at a reassuringly slow pace. For the patients and our sakes, I hope so.
GLTA, Paul
Most importantly, we remain on schedule to complete patient enrollment in the SUNRISE Phase III trial in NSCLC by the end of calendar year 2015
This on-time enrollment is why King can say Sunrise will be unblinded in 2016.
Listening to the CC I was struck how positive management sounded. They seem very optimistic that Sunrise will succeed. They seem very optimistic that the post-Sunrise clinical trials will also succeed.
If we can judge anything from the overall tone of the CC, Peregrine management expects a steady stream of good things to come.
I also found it interesting that they still want to partner ex-US. Does this mean they think shareholders will get better value if they can retain US marketing rights? I hope so.
GLTA, especially the Bavi-arm Sunrise patients.
No PR yesterday or this morning. I hope they have saved some positive new information for us in the CC.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Very, let's hope your very, very wrong.
GLTA, especially Bavi-arm Sunrise patients,
Paul
Geo, strongly agree that the CA has nothing to do with anything at this point. I would add that the CSM trial has little to do with anything now - win, lose or draw.
I don't think Peregrine management needs the CA as an excuse to keep company information from the public, i.e. us. Unless required by law or explicitly serves their purposes, we get little to nothing out of these guys.
I don't buy the competitive advantage arguments. I believe they fear criticism of their decisions. Too bad they are so insecure. One other point, they don't have to spend a lot of resources on investor relations. All you need is some guy to say, "I can't answer that", or "Nobody else in the industry would answer that", or you get the idea.
GLTA, especially Bavi-arm Sunrise patients.
Paul