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NAVB Lymphoseek crowd doesn't see PPHM locomotive
I had a position in NAVB but sold it knowing what I know now about I-124 PGN650. We could all wind up being surprised by the billions flowing into it. Oncology imaging is an ENORMOUS field.
So while we are eagerly awaiting a partner for oncology Bavi, imaging might very well be our first cash cow.
GLTAL!
Joe
So that's why PPHM is consistently the busiest board on IHUB?
Jim, just hold on
Always enjoy your posts. But it is actually your great confidence in Bavi ( mine as well) that is holding things up. We have a winner on our hands (big time) so consequently, the negotiations will prove HARDER than ever to hammer out.
Thus, everyone is tight-lipped. Bavi is "THE" upstream checkpoint for immunostimulatory modulation. Scientists, execs, and BP know this.
Be patient. Try checking in here a bit less often. Have confidence in your DD. Relax.
Ask yourself one basic question: Is my confidence in Bavi increasing or decreasing? Is the company holding more conferences or less? Are there more interesting data or less? Are there more positive signals from the FDA or less? Do we have more debt or less? (Trick question: we have NONE)
Best,
Joe
Great post, CP
unselfish of you to share your thought processes with others (in an extensive way). I'm putting my thoughts together on this, too, and will post soon.
Best,
Joe
4OUR, re-read CP's classic posts
1 - The naysayers are slinking away...quietly
2 - Haven't heard "Bavi is a placebo" in MONTHS
3 - ASCO 2013 was ALL ABOUT immunologics with Bavi smack central
4 - EOP2 was supposed to a fiasco; instead, it went smoothly
5 - PPHM knows more than ever about how to combine AND time Bavi
6 - Bavi needs immunostimulatory chemo to generate brilliant results
7 - Bavi 2nd line kicked butt, one, because of docetaxel (immunostimulatory) and two, because of the PS extroversion that resulted from first-line chemo
8 - PIII approval is for...guess what? Second-line bavi plus docetaxel; (awesome set-up for PPHM)
9 - UPMC is really world-renowned (first kidney transplant; first-class oncology center; biostrategic defense) and THEY feature Bavi prominently ???!!!
10 - All IP owned 100% by PPHM? Oh yeah, baby.
In short, hold tight.
We've never been in this position before.
Here's my assessment:
It has been unequivocally proven beyond doubt that the error is NON-attributable to PPHM, and in fact originated in a third-party pharmaceutical trial-processing facility called CSM in Fargo, ND. The Street still blames PPHM for the error (as you, unfortunately, do as well).
Making money in biotech means being invested before the hoards rush in. PCYC, ARNA, CLSN (before it crashed), and MNKD are all examples of stocks that languished at a $1.50 price point for AGES, right up to the point where they burned through the roof and blew past all investor expectations.
PPHM investors are convinced that immunologics are the leading salient in biotech oncology at this time, and that Bavi holds great promise as a potent immunomodulator. Interestingly, the timing and combination of Bavi with other chemotherapeutics has become increasingly crucial. When combined with immunosuppressive chemotherapy, results have been found wanting. However, when combined with immunostimulatory chemo, (such as docetaxel), Bavi has performed brilliantly.
Nay-sayers will point to supposed censuring of patients under Bavi's different regimens, accusing PPHM of essentially "cherry-picking" their results. Sorry, but that's not how Dr. Robert Garnick (of Genentech/Roche fame) works. Quite conversely, the majority of studies with Bavi involved some of the WORST patient populations in their trials.
Partial and Complete responses were seen in breast cancer studies presented at ASCO 2013. The EOP2 meeting for second -line NSCLC with the FDA was described as "straight-forward" and "really no big deal", with PPHM effectively putting the third-party labeling error behind them (despite the Street's obsession.)
While I can most definitely appreciate your prudence with the "good-looking" PPHM, Frederick the Great also applies: "L'audace, l'audace, toujours l'audace."
The "cut, burn, and poison" approach to cancer has failed over the past 40 years with many cancer PFS rates shockingly stagnant. No real progress has been made, despite a few exceptions.
The new salient is to boost the immune system and perhaps, more importantly, to first prevent the tumor micro-environment from shutting it down in the first place.
Either you decide to board this train early, or you don't. Paradigm shifts aren't paradigm shifts anymore when everyone "gets" it. Either you're ahead of the curve or behind it.
Good luck.
Whoa. World-Class UPMC features Bavi
They prominently feature Bavi as a broad-spectrum anti-viral.
I'll say it 'til I'm blue in the face...
"Immunologics are the leading salient right now in Oncology and Infectious Disease."
Get me some dry powder....fast!!
Best,
Joe
My response to latest SA article
Nice article, with the exception of blaming PPHM for the labeling error. It has been unequivocally proven beyond doubt that the error is NON-attributable to PPHM, and in fact originated in a third-party pharmaceutical trial-processing facility called CSM in Fargo, ND. The Street still blames PPHM for the error (as you, unfortunately, do as well).
Making money in biotech means being invested before the hoards rush in. PCYC, ARNA, CLSN (before it crashed), and MNKD are all examples of stocks that languished at a $1.50 price point for AGES, right up to the point where they burned through the roof and blew past all investor expectations.
PPHM investors are convinced that immunologics are the leading salient in biotech oncology at this time, and that Bavi holds great promise as a potent immunomodulator. Interestingly, the timing and combination of Bavi with other chemotherapeutics has become increasingly crucial. When combined with immunosuppressive chemotherapy, results have been found wanting. However, when combined with immunostimulatory chemo, (such as docetaxel), Bavi has performed brilliantly.
Nay-sayers will point to supposed censuring of patients under Bavi's different regimens, accusing PPHM of essentially "cherry-picking" their results. Sorry, but that's not how Dr. Robert Garnick (of Genentech/Roche fame) works. Quite conversely, the majority of studies with Bavi involved some of the WORST patient populations in their trials.
Partial and Complete responses were seen in breast cancer studies presented at ASCO 2013. The EOP2 meeting for second -line NSCLC with the FDA was described as "straight-forward" and "really no big deal", with PPHM effectively putting the third-party labeling error behind them (despite the Street's obsession.)
While I can most definitely appreciate your prudence with the "good-looking" PPHM, Frederick the Great also applies: "L'audace, l'audace, toujours l'audace."
The "cut, burn, and poison" approach to cancer has failed over the past 40 years with many cancer PFS rates shockingly stagnant. No real progress has been made, despite a few exceptions.
The new salient is to boost the immune system and perhaps, more importantly, to first prevent the tumor micro-environment from shutting it down in the first place.
Either you decide to board this train early, or you don't. Paradigm shifts aren't paradigm shifts anymore when everyone "gets" it. Either you're ahead of the curve or behind it.
Good luck.
Crutcher was dying to be a fly on the wall
at the EOP2 meeting for second-line. He stated he would "love to be there" to watch PPHM struggle to explain the labeling error.
Uh, too bad so sad, Patrick. PPHM revealed the EOP2 meeting was "straightforward" and "not really a big deal."
FDA gave the green light, as we all know.
Except Patrick.
Best,
Joe
CP - outstanding post, finally some sanity
Coupled with today's SA article, PPHM is finally get some recognition as to its potential, all made possible by the GREAT work done by the BoD to get PPHM where is it right now:
and that would be the BEST position it's EVER been in.
Best,
Joe
OK, Vanessy, repeat "Sunday night" after me
Wow, talk about impatience. It's Sunday night, and you're brow-beating posters to respond to a post YOU want answered. (Hey, here's an idea, why don't YOU answer it?)
Go enjoy the rest of your weekend. Sorry, back to the ballgame. Please give it (and us) a rest.
Best,
Joe
EBS, we'll get there because
Bavi plays too well with other regimens. In my exposure to the nuances of BP, this fits the oncology field well.
The oncology field is essentially a conservative one. Believe it or not, they don't like change. OK, maybe a little, and I better get more money out of it. If it helps patients (a little), then that's good, too.
Oncology is all about SOC. It takes a while to change SOC. It takes a while to change attitudes. It doesn't happen overnight. Doctors are a conservative bunch. Oncology doctors are a super conservative bunch.
I doubt very much it'll take your time frame for Bavi to take off. Immunologicals are the "newest" addition to SOC that can fit right in to established regimens. They don't steal the show, they just make it more expensive, and do help patients. In other words, they're perfect.
Best,
Joe
By P1, I assume you mean first-line
By "shaking out" retail hands, that includes pre-empting any buying. You've got to admit, PPHM has had just about all the negative publicity you can get. And it's working.
No wonder nobody wants the stock.
Someday that will change.
Best,
Joe
John, CSM set us back a year
Bavi and Docetaxel will blow your NSCLC doors wide open in PIII, not to fret.
We just got sucker-punched in September, 2012. Kinda like Zimmerman got sucker-punched.
Everything got pushed back one year. Yeah, that sucks, but such is life. "Roll with it."
Best,
Joe
Great post, Gull
We saw a lot of long-time longs lose their heads with the posting of first-line.
They just didn't trust themselves and their DD. We dropped to $1.11 and bounced right back up once everyone realized the PR wasn't bad. C+P just didn't groove with Bavi in first-line, given its MOA.
That's what King means when he says we've really got a hold now on what combos work well with Bavi.
Now what's fascinating is that PIII for Bavi is with Docetaxel, which works VERY WELL with Bavi, as CP and Biopharm have documented and repeated here into they're blue-in-the-face.
P2 gave fantastic results, really more than 100% of SOC, given the fact that "placeco" got Bavi, and the 3 mg/kg dose kicked butt anyway.
So where do you think p3 is gonna wind up? One answer: Garnick knows. And so does BP.
I stated during the panic of the first-line results that one great benefit would be to "clean out" the board of weak hands. Some posters, who shall remain unnamed, slinked away, after announcing their "wisdom" to us that they had "sold all shares," apparently leaving us holding the bag.
Gosh, what great advice. They're out of the stock, PPHM bounced right up, and the latest CC gave more confidence than ever.
In the days ahead, what measly advice I can offer is this: TRUST YOURSELF. Lots of dirty games are coming, and many will fall.
Best,
Joe
EBS, they own 100% of the IP
Yeah, they've had to dilute. Welcome to biotech. Yawn.
But "the multiplier" is there. If Loof's rocket takes off, all the glory is ours, not someone else's. Why? Because we own all the rocket fuel.
If we've had to dilute to own everything, so be it. I'm confident in the science, love the mechanism, have studied the synergy with other chemo, and look forward to combos with anti-PD-1.
Best,
Joe
Paul, when a dog bites hard, you stay away
PPHM got bitten HARD on 9/24/2012. Management is still binding that wound. The hesitancy to provide details to shareholders is justified.
When they do comment, everyone says, "Well, the Street doesn't trust whatever they say, anyway."
Now you want them to start talking again. If I were in their shoes, I would keep my mouth shut, too.
Best,
Joe
Stone, great point: Bavi is HUGELY synergistic
Combining upstream Bavi with downstream PD-1 basically captures ALL the excitement at ASCO this year.
Bavi makes other chemotherapeutic agents BETTER and that plays right into the oncologic mindset, which is essentially conservative (i.e. SOC, comfort level with established drugs, suspicious of "new-comers")
When you add something "not just new by itself," but "new in good combination with established drugs," you are able to warm up to the oncology field.
This is Bavi's strongest point: it is a SAFE synergistic MAB that plays VERY well with established drugs in the oncology space.
Best,
Joe
More confident than EVER
Cash on hand 42 M
Street expectations met and exceeded
First-line was stopped because it was the WRONG combination; (Carboplatin axed Bavi's chance to fire up the immune system)
Avid expects ANOTHER banner year (2014)
NO more "Going Concern"
Bavi is the "upstream" player to PD-1 downstream MOA
Thus, MORE partner discussions, MORE possibilities, MORE avenues for Bavi
SK, Shan, et al, handled the call more professionally than prior poor performances
Pre-clinical trials with Bavi and PD-1 ALREADY underway with clinical by year-end
More employees than EVER and an improving bottom line to boot
Second-line P3 starts at year-end
Go Bavi!
Best,
Joe
No partner announcement on CC - obviously
Good solid QUARTERLY report; don't understand why everyone wants fireworks?
Very positive CC; great Avid; PPS up tomorrow
No doubt.
Best,
JOe
Motley goes PPHM (+) Huh?
I would say this DEFINITELY is going to be an interesting week. Hope everyone holds tight. Take out your stops IMO - they could easily be taken out in volatile trading. Although, I will say, if Motley Fool goes positive on PPHM, what the heck is going on?
Best,
Joe
FROM MOTLEY
3 Predictions for Next Week
By Rick Munarriz | More Articles | Save For Later
July 7, 2013 | Comments (4)
[...]
3.Peregrine Pharmaceuticals will beat Wall Street's earnings estimates
Some stocks are just flat-out better than others.
Peregrine Pharmaceuticals (NASDAQ: PPHM ) is an upstart biotech targeting the treatment and diagnosis of cancer through monoclonal antibodies. It has a potential winner in its lead candidate that will begin its telltale phase 3 clinical trial later this year.
Another thing it does is make analysts look like perpetual underachievers. If analysts say the company posted a loss of $0.06 a share in its latest quarter, I'll argue that it held up better than that. History's on my side!
Things can change, of course. Despite posting lower deficits with every passing a quarter -- a welcome trend in and of itself in eyeing the loss that analysts are forecasting -- it's certainly not cheap to ramp up pivotal late-stage clinical trials.
However, it's hard to argue against the trend. Everything seems to be falling into place for another market-thumping quarter on the bottom line.
Gloomy-doomers said sub-$1; Bavi strikes back
Yep, everyone freaked and listened to the ever-predictable "doom and gloom" crowd after our fun little PR, but did Bavi care?
Uh, that would be a "no."
Nice rebound from $1.11 to $1.45 in just 3 days. Hidden buyers everywhere. Hmmmm.....
Hang tough,
Best,
Joe
Stone, nice to have you back
Hang tough. Bavi will be there for us. It's coming.
Best,
Joe
Panic-sellers did not trust their DD
And frankly, it serves them right. They got burned today with the bounce back and excellent news because of one simple, yet critical mistake: they didn't trust themselves.
We saw a LOT of turncoats yesterday. Posters who anyone would think were diehard longs, full of DD, reasonable, measured, and contributing regularly to the board.
But boy, did they tuck tail and run!
Look, the darn drug WORKS. It's obvious.
You pays your money and you makes your choice.
IMO, big news is coming shortly and true longs will be rewarded.
Best,
Joe
Stone, after all your DD, all your posts, and all your time spent researching, reading, and responding to everyone here, THIS is your conclusion?
I don't get it.
The stock loses 20%, holds up much better than the doom and gloom crowd predicts, we still don't have the full data, yet we do know Bavi gave CRs in breast, Avid is generating cash, and second-line goes to PIII.
I don't get it.
You might consider "throwing in the towel" and buying Philip Morris, or McDonalds. I'm serious.
This just seems an enormous waste of time for you.
Best,
Joe
So disappointing to doom crowd - PPS STABLE
Didn't get your schadenfreude today.
Back to February levels. Ho-Hum.
Phase III, Avid, imaging, complete responses in breast.
You can either panic or hold on.
Climb, baby, climb
Phase III, Avid, imaging, breast cancer complete responses.
You can either panic or hold on.
War, ur unclear on the concept
First-line NSCLC is OPEN-label. That means it is IMPOSSIBLE to have a labeling error as seen in second-line.
The PI sees the dosage on the label and gives it. There are no "hidden" coding labels as in a double-blind trial.
ECG, exactly the perspective needed here
I've been trying for a long time to urge patience and perspective on this Board. I've tried to encourage many to follow their research, to keep confidence in their DD, not to get flustered, or (worse) become a complainer. (Gets real old fast).
You, however, did all that and more with your outstanding post.
Great job, dude.
Best,
Joe
RRDOG, Outstanding post of the day.
Measured. Reasonable. Thorough. Logical.
Excellent.
Best,
Joe
Gwen, let the story play
Stocks, especially biotech stocks, will in general BORE you to death.
...until that one day, out of the blue, everything changes.
That's what will happen with PPHM.
I've said it before and I'll say it again. This stock can trade 60 million shares in a day, 100 million in 3 days, and 200 million in a week.
It can go back to $5.50 in a HEARTBEAT.
Just remember that as you watch the grass grow, paint dry, et cetera.
Best,
Joe
Instant gratification comes not to the impatient
Everything in time, my friend.
Best,
Joe
Dips are buying opportunities, people
Rather than toss months of good DD overboard and cry like a girly-man when your beloved PPS turns down, why don't you add?
Simple question to all.
Best,
Joe
Great summary, PGG. Bavi is opening up a can
of whoop-a** on cancer. (especially breast and NSCLC)
Many, many competitors out there do NOT want Bavi to succeed. All part of rough and tumble biotech. Hey, it comes with the territory.
Hold on to your shares! Riding out the turbulence is the key to everything.
Best,
Joe
Excellent, Geo. More confidence. Bavi works.
And it works well. Let's get this medicine out to patients ASAP.
The breast cancer results blow away the "Bavi-is-a-placebo" naysayers - they realize now they'll have to take another tack.
Expect more attacks. Much more. Expect the following:
1 - PPHM can't/won't/doesn't merit a partner (sure - with immune biologicals being the leading salient in oncology and Bavi just happens to be the safest, most effective Mab out there. Riigghhht...)
2 - PPHM doesn't have the money to run a PIII trial (Riiigghhht ...see #1)
3 - Bavi won't show efficacy in Phase III (Riigghht... it's just continues to give more than enough indication that it will)
4 - Bavi's NSCLC second-line data was "botched" in Phase II. The company can't be trusted. (Riigghht... how much longer will this canard have legs, despite all the FDA approvals, and great ASCO presentations? Probably forever.)
Et alia....
Hold on tight, longs. Our day is fast approaching.
Best of luck and data (a la wook)
Joe
Dron, Mr. Pantiginis viewpoint lasts >48 hours
I know instant gratification takes too long in the good ol' US of A, but hold off for more than 1-2 days before writing his epitaph.
Best,
Joe
850 out of 1000 women responded to Bavi
and 127 out of those 850 responded COMPLETELY to Bavi!
This is what the breast cancer results mean. Partnership is coming.
Best, and Good luck to all longs!
Joe
Dog, the biotech landscape changes so quickly
your decision to quote a PPHM analyst from 2011 might as well be 2001.
Stale observation. The recommendations require context, as Bio points out. 2011 was negative attack season on PPHM, then September, 2012 brought its own challeges, and now, in June 2013, we have finalized data sets from ASCO. Again, the dynamic changes VERY quickly.
But you sound like a seasoned investor. No hard feelings.
Good luck.
Joe
Which way is the data moving, dog?
In the first study presented, interim data from a Phase I trial evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC) showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria.