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We are overdue for some news IMO. Tomorrow would be nice.
GLTA, Paul
Thanks, CP. Based on your/Golfho's estimates the DMC could issue an interim report at any time. My research on FDA guidelines for DMCs leads me to expect minimal sharing of data with Peregrine management. Of course, it may be the Sunrise DMC instructions are more liberal.
As to a PR from the first look-in, I fully expect one. I just hope Peregrine will have some data other than enrollment progress to share. By this time I believe the data should give an indication if the Phase III effectiveness mirrors the great numbers we saw in the Phase II. This is what would reassure me that the trial will likely be a success, and not coincidentally we will make money.
GLTA, Paul
The CSM trial progress is interesting, but ultimately irrelevant in my view. All eyes have to be on Sunrise and Bavi-Yervoy. These two trials can move the needle.
GLTA, especially Bavi patients, Paul
Hypi, of course the share price sucks. Of course, prospects for Peregrine have never been better. A contradiction, isn't it? All contradictions are eventually resolved. I hope the resolution makes me a pile of money before we reach the same point next year.
GLTA, Paul
The silence is deafening around here. You'd think this was the old Techniclone/Peregrine that was years away from achieving anything.
Instead we have a company almost a year and half into a Phase III trial in a fast-tracked drug with 150 plus worldwide sites.
I expect by the end of this month Peregrine will have generated enough news to move us above 1.50. You heard it here first.
GLTA, Paul
These periods with no Peregrine news of any consequence sure do wear me out. Those of us who actually watch the company closely know news is coming soon.
Might be minor news, might be major news. If it is minor good news we go back over 1.40 at least for a few hours or days. If it is major good news, we would have to go higher.
On the minor good news, we would have a Sunrise DMC update that enrollment is going well and no unepected adverse effects have arisen. Or another minor good news would be the start of a Bavi-PD1 Phase1 trial with little PR sizzle. Or small sample modest good news from the Bavi-Yervoy trial.
The major good ranges from Sunrise homerun numbers leading to a trial stoppage and request for early FDA approval. Other major good new could be homerun numbers from the Bavi-Yervoy trial. Or perhaps, a Bavi-PD1 Phase II trial with lots of sizzle from a BP trial collaborator. Or a Phase III breast cancer trial with a BP collaborator.
Of course, a lucrative partnership or buyout would be a game changer.
I don't want to consider the bad news scenario.
In any case news is coming. Until then the SP languishes.
GLTA, Paul
Sunrise is running on track according to management.
Bavi-Yervoy have been running for months in an open label trial that could generate news any day.
Management told us to expect Bavi-PD1 trial announcement soon.
The dozens of collaborations mentioned last year may yield new trials or serious contacts with BPs.
Avid was expanded for a reason.
Emerging cancer therapies are unlikely to cure cancer. So, the need for a side effect free cancer fighter like Bavi will continue indefinitely. Assuming Sunrise and other trials come through the way we optimists expect.
The company has no immediate funding problems I can see.
On the legal front:
The CA has always been marginal at best. Probably kept running by lawyer with more greed than brains.
The CSM lawsuit might or might not generate a nice little payday for Peregrine but is basically not critical to company success.
In view of the above, I am more optimistic than I have ever been in my 15 years owning Techniclone/Peregrine shares. Still no guarantee of success, but the odds continue to improve IMO.
GLTA, Paul
Agreed md1225, we can expect news on both fronts in the next weeks, maybe days. King and company said the Bav-PD1 clinical trial was in the process at the last CC. Clearly, this could come at any time. How impressive the launch might be remain to be seen.
As to the Sunrise interim, the DMC might not be able to share much. We'll just have to wait, but I don't think this will take more than a few weeks to a few months.
GLTA, Paul
I see the despair level rising again. Peregrine management seems to have an uncanny ability to generate good news at such times. I don't attribute this to any shareholder friendly intent. It's just they are working very hard to make good things happen IMO.
Prepare to be pleasantly surprised in the next few days.
GLTA, Paul
Based on the somewhat reliable Ihub Peregrine posting activity indicator, I predict a share price increase tomorrow.
Good luck to all, especially Bavi arm Sunrise patient, as well as the Bavi-Yervoy subjects.
Paul
verylong, I disagree with several points. Let's see.
All earlier trials were failures. One example refutes your statement. Clearly, the breast cancer trial was not a failure. Perhaps you should do more DD.
There will be no results in 2015. Amazing crystal ball you have in April to write off the rest of the year. I prefer to think the Bavi-Yervoy will result this year, as well as the Sunrise first interim look.
No partner this year. See above.
GLTA, Paul
k_t, my research on FDA guidelines for DMCs leads me to believe we cannot expect any kind of efficacy data from the interim look-in. More likely we'll just get a good idea how the trial enrollment is going.
If we do get efficacy data, I believe it will signal very good or very bad results. Of course, I think very good results are much more likely based on prior trial outcomes.
GLTA, Paul
Sunrise. The non-Bavi arm patients must be eventing with terrible regularity at this point. If Bavi is working well, the Bavi arm patients may have had very few events. When we hit the first interim look point, probably very soon, I have to wonder if the Data Monitoring Committee has the authority to halt the trial on humanitarian grounds. Maybe it is just the hopium talking.
GLTA, Paul
r_m, as long as Peregrine management continues to push Bavi to commercialization as fast as possible without undue dilution, I don't fault them for the lousy share price.
BPs don't see the value that we see. Those who buy and sell the stock don't see what we see. Peregrine seems to be doing their best to promote Bavi. So, we wait until the value is irresistible. Then, we will see the SP we want. This will not be soon enough for many.
Some day, if we are right about Bavi, we will get our reward. Maybe this summer, maybe not until next year. I believe the wait will be worth it. We'll see.
GLTA, Paul
Sunrise enrollment should be approaching 360 patients in my guess. That's three times the size of the related Phase II study. No showstoppers yet.
My only concern at this point is that the Data Monitoring Committee interim report will not share the detailed information we all crave. I like to think blowout numbers might force early trial conclusion on humanitarian considerations.
We'll see.
GLTA, Paul
I like to think Peregrine shares more information with Piper Jaffray than they do with us. If so, the very upbeat tone of the entire PJ article bodes well for us. Maybe that $4 price target will fall sooner than some think.
GLTA, Paul
Bavi – Not Just Another IO Candidate
DMC guidance from the FDA. To answer my own question:
In many cases, the DMC receives reports in two parts: an "open" section, which presents data only in aggregate and focuses on trial conduct issues such as accrual and dropout rates, timeliness of data submission, eligibility rates and reasons for ineligibility; and a "closed" section, in which the comparative outcome data are presented. The open section of these reports is usually provided to sponsors, who may convey any relevant information in these reports to investigators, IRBs, and other interested parties, as the data presented in the "open" section are not likely to bias the future conduct of the trial and are often important for improving trial management.
Any idea how much information might be available to Peregrine and we lowly investors at the first look-in? Perhaps one of you with good relations with Chris Keenan could ask him what the DMC might share with us. Obviously he has no crystal ball but he might be able to say whether current enrollment numbers will be revealed. Or what the breakdown is between evented Bavi and non-Bavi arm patients.
It would be nice to know what kind of data, if any, we can expect.
GLTA, Paul
Predictions.
One year from now PPHM shareholders will be much richer than they are today.
One year from now NSCLC patients will be living longer with Bavi in their veins.
One year from now no culprits other than Bleeker and her supervisors will be identified.
One year from now Peregrine will be an appendage of a much larger entity.
One year from now The Saint Louis Baseball Cardinals will have won another World Series.
This predicting sure is thirsty work. I need an Goose Island IPA.
GLTA, Paul
Sunstar, I agree CSM put back the Bavi timetable. I don't know if the FDA would have approved Bavi based on the Phase II results. I guess we will never know.
Meanwhile, Sunrise continues to treat and enroll patients. Like some I expect to see the first look-in in the next few months. I don't know how much the DMC will share with Peregrine and us. I hope it will at least equal the strong numbers from the Phase II.
I don't buy the conspiracy theory, but you don't have to believe in that story to expect Peregrine/Bavi will help a lot of sick people and make us a pile of money.
GLTA, Paul
jimsgtx, I agree completely. There will be important events over the course of 2015. Too much bubbling in the pot.
GLTA, Paul
CP, I am aware of all the studies you cited. In fact I read all the patents applied for and approved before the studies even commenced. The early trials you cited only showed the promise of Bavi. In fact they showed that Bavi was not a silver bullet only a useful adjunct to the existing standard of care.
As you are well aware, early studies often show promise, and then the drug fails in more advanced trials. In 2010/11 Bavi was in the same position.
No sensible BP would risk the financial, legal and public relations disaster of the Fargo conspiracy to keep Bavi, or any of the dozens of promising early drug candidates, from completing a Phase II trial IMO.
Sorry, this just doesn't make sense to me.
GLTA, Paul
Everybody loves a good 3rd party conspiracy theory to explain JB's actions. Evil corporate execs try to sink plucky upstart Peregrine. I find this unconvincing for one very simple reason.
There was no motive for a 3rd party to launch the conspiracy:
1. Bavituximab's MOA was not well understood at the time of Fargo. Additionally, there was little evidence at that time that Bavi would be a useful drug at all. The huge unanswered question here is: why would anyone sabotage a tiny company with a drug of uncertain usefulness. Why take on the multiple serious risks of a conspiracy? Every BP knows how to evaluatate a risk-reward situation. In this case the potential risks far outweighed the potential rewards.
2. In the unlikely event a BP had the foresight to see Bavi as a lucrative prospect, there are other, simpler, ways to get their greedy little hooks into it. Partnering and buying. Many BPs are cash rich and pipeline poor. Peregrine could have been had cheaply at the Phase II stage. Why risk a theft, when you have a ton of cash in your pocket?
Before advancing any other arguments, I am very convinced that the motivation for a 3rd party attack on Peregrine at that time was flimsy.
We all love Bavi, but back in 2011-2, the case for Bavi was not yet credible.
Beyond the fact that there was little to no motive to sabotage BaviPeregrine. There are many other reasons to disbelieve the conspiracy theory.
For instance, say there was a conspiracy. Once the evil BP realized that JB was caught, what would they do? Let CSM fight a losing battle in court? Maybe not. Given the improved likelihood of Bavi's value, why not just gobble up Peregrine at a reasonable price and quietly let the lawsuit disappear?
Or, if the evil BP does not want to get caught, why not just relocate JB overseas. How much would that cost compared to the legal fees.
Or, the evil BP could have quietly funded a settlement agreement for CSM many months ago before the discovery process could uncover too much.
The third party conspiracy theory requires the evil BP to be so bright that it could figure out how valuable Bavi might be years ago, so stupid as to launch the conspiracy, and too stupid to take any of the easy paths out of the mess when it blew up.
Oh yes, it also requires us to believe that JB was a competent saboteur. She was a lousy saboteur. She even kept records of her mislabeling.
The crime shows all say the perpetrator needs motive, means and opportunity. In my view there is no credible motive. I would look for another cause for the Fargo Fiasco.
CSM screwed up. They know it. We know it. The judge knows it. The only question in my mind is how much money Peregrine can get from these losers.
GLTA, Paul
CP, I still don't see Bleeker as a paid saboteur for several reasons.
First, why play the mislabeling game in such a way that the trial results looked so good that Peregrine was getting a partnership deal and heading to the FDA for early approval? Why not mislabel so the Bavi arms looked ineffective? If I were the saboteur, I'd mislabel all three arms, not just two.
Second, why leave CSM before the trial is over? Why keep detailed records of the mislabeling then not stick around to harvest the data to forward to her spy masters?
Third, how does the testimony that Bleeker was "in over her head" at the outset of the trial, the kickoff meeting, square with the idea that she was a competent technician who would have known better than to re-randomize a trial.
I still see gross incompetence on her part and on CSM management. I also see criminal culpability if CSM attempted to conceal what Bleeker had done.
She seems much more like an idiot than a saboteur to me.
GLTA, Paul
One interesting new allegation by Peregrine's lawyers is that they believe there was evidence that CSM attempted to conceal what Bleeker had done. If this is persuasive evidence, CSM will be in real trouble IMO.
GLTA, Paul
Peregrine's attorneys certainly took off the kid gloves didn't they? I wonder if the judge is swayed by all the rhetoric.
It certainly looks like CMS is going to drag this out until the trial date. Then, I expect they'll settle rather than face a jury with their pathetic excuses.
GLTA, Paul
According to clinicaltrials.gov the Bavi-Yervoy trial started recruiting a year ago. Maybe we will see something soon on this open label trial. A little good news would really help.
GLTA, Paul
The Sunrise trial is approaching of a year of enrolling and treating patients. I hope the bavi patients are enjoying much improved health.
As they used to say on the X Files, the truth is out there. I hope we see some of that Bavi truth soon.
GLTA, Paul
bidrite, those of us who read the patent applications and publicly available clinical and pre-clinical research articles are persuaded the science supporting Bavi, most specifically its method of action, is well established.
What is not well established, and many hope/expect the Sunrise trial will prove, is the effectiveness of Bavi in the treatment of NSCLC and other diseases.
When this effectiveness is proven, then the BPs will validate Bavi/Peregrine with their checkbooks.
At that point no one will care about institutional ownership, the merits of the BOD, what happened to Cotara, or any other financially irrelevant matters.
GLTA, Paul
Perhaps, the divide between those who focus on the solidly verified science of Bavi and those who focus on the bargain basement share price and related atmospherics explains some of the acrimony shown here.
Personally, I am a science guy who appreciates a bargain. So, I find those who focus on the share price tiresome.
The good news is that if the Sunrise trial succeeds as well as we science guys think it will, the share price guys will have something to cheer about.
GLTA, Paul
I don't think we need concern ourselves with the BOD's reputation for good or ill, if the Sunrise trial produces a huge increase in overall survival. The BPs will be there with their checkbooks and their spreadsheets trying to buy Bavi/Peregrine as cheaply as possible. Fortunately, I expect a bidding process that should put a market price on the deal.
Could be this year.
GTLA, Paul
Hypi, care to predict next week's high and low share prices. Your last week prediction was not accurate. Maybe you will have better luck this time.
GLTA, Paul
I boldly predict Sunrise will treat more patients next week. I further predict they will continue to enroll patients.
Perhaps, the Bavi-Yervoy trial will finally generate some news next week. If it does, the share price next week may top $2.
GLTA, Paul
I don't know that Peregrine management has the number of enrollees. I saw a suggestion that they can get a close guess based on Avid's shipment of Bavi doses. Don't know if this is reliable or not.
Regrettably, Peregrine management has not shown much concern about its shareholders comfort level IMO. If they deliver the goods, I'll forgive them.
GLTA, Paul
Sunrise. Another day treating and enrolling patients. The suspense is killing me.
Are the Bavi patients doing well?
Are we approaching the first look-in?
Will the DMC release much information to Peregrine?
Will Peregrine release much information to us?
Will the share price jump out of the $1 range?
Will the negative posters here admit they were wrong? I know at this point we have left speculation and entered the realm of fantasy, LOL indeed.
GLTA, Paul
Hypi, I know it's early, but so far your prediction of a share price of 1.29 this week is off. I hope to repeat this message on Friday.
Also, on your oft-repeated prediction of a financial doom. Many fortunes were made, not when the market achieved new highs, but when risk takers bought into horrendous dips. One man's disaster can be another man's creation of a financial legacy that will endure for generations.
Maybe buying Peregrine at 1.40 will generate fortunes for us.
GLTA, Paul
north40K, the market will respond to a 50% increase in the overall survival from the Sunrise trial IMO. Then, we will see how far and fast this bird can fly.
GLTA, Paul
Hypi, you mean I bought too early last week at 1.34? Dang!
Actually, nothing is guaranteed this week. News isn't guaranteed, nor is no news. Jeez, that's a lot of negatives. Then again, some folks like negativity.
Maybe next week will surprise you with some good news, and the share price may finish above 1.50. Or not.
GLTA, Paul
Sunrise. An appropriate topic for Easter. By my reckoning we are now entering the 12th month since the announcement of 25 opened US Sunrise sites. 130 plus worldwide sites have been added since then.
Based on the "on track" reassurance from Peregrine, Sunrise has completed treating well over a hundred patients in the initial protocol, many we hope are getting continued Bavi treatment.
Again based on the above, Peregrine may have begun treatment of about 300 patients. Many patients, doctors and of course the Data Monitoring Committee must have a sense of how this is going. Obviously nothing bad has happened or the trial would have been shut down.
Some news is going to slip out or be formally released in the next few months IMO. If Sunrise replicates the very similar Phase II study, we will be just fine.
GLTA, Paul