Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I actually switched from ELN to TTHI as a major holding because I thought development of ELND-005 would likely benefit from either bapi success or failure. I guess we're going to test that theory now...
OMG.
Although not totally unexpected. I attended a symposium here in London and the main presenter, although he didn't address bapi directly, suggested that all the trials to that point were initiating too late in the degenerative process to succeed. That's the main reason I didn't go back in, although we still have shares in my wife's IRA account.
If we're over $5 in December, I'll go. (Of course, if we're over $5 in December, we're going to be over $10...) Anybody join me?
I'm saying it's better to have brilliant MOS data in hand than the possibility, however likely, of brilliant MOS data in the bush.
Geo, the FDA will have decided this thing long before the patient has the option.
How can this go bad?
How did the first line data suddenly become confounding after the encouraging top-line data release -- after the companies strong statements on how the data was trending so well?
Did you anticipate it?
I expect this story has a happy end for us. There's a chance I'm wrong. It's in the nature of the Black Swan to arrive unexpected.
Impossible to say. Is management being cagy by not releasing the numbers? Management says the data's not mature. That seems reasonable to me but how can we know? I felt, when the question was raised during the webcast, that SK (I believe it was SK) seemed hesitant and at the time I wondered why. I sense risk.
But the bulk of what I see convinces me that management is being straight. I'm concerned, but not overly. If the s%^t hits the fan, I won't be entirely surprised. I'll be less surprised if the s%^t hit's Dew's fan.
Dew's concern regarding the release of a HR cannot be dismissed summarily. I hear management say that they will release those numbers when the data matures. I tend to believe management in this instance, but they have led me down the garden path before -- in relation to the government HFV contract and in relation to the 1st line trial.
The jury is still out on this one. My bet is made, but I recognise there is still significant risk here. I won't be entirely surprised if they roll snake-eyes.
Continuing: Perspective on Dew
Dew's assertion, All the while, management is busy selling ATM shares on the cheap, which they surely would not do if any of the above were truthful, is also of the opinion ilk. Insofar as he relies on Adam to make his point, his argument suffers.
Dew did call the 1st-line data flop. I wouldn't dismiss his concerns out of hand. I await the bottom-line 2nd-line data with some apprehension. But one has to say of Dew, it's his intuition, not his argument that give one pause.
Is Dew a broken clock, a Svengali, or an oracle? To find out, we'll have to stay tuned...
I just had time to re-read Adam F's piece. As a journalist, I would call it an opinion piece but not a good one.
He asserts as fact things that are clearly false -- things that would have been easy to fact check if he cared.
Adam's central assertion regarding the opaque nature of the ATM lacks discipline. Saying that they haven't been transparent enough for investors, you have to wonder which investors? The senile? The insentient? Anybody listening to their conference calls, reading their quarterly reports (things all investors ought to do and especially biotech investors) knows rationale and the details of the ATM -- knows why management would have been suicidal not to raise cash during this period of low stock prices.
As the assertion that management has been opaque lacks credibility, the argument that management is two-faced fails to persuade. Adam's sound and fury signifies nothing but hubris.
It's sad really. I remember back in 2007 when Adam would actually go out on a limb as he did with Dendreon. I'd like to see that Adam come back. He was actually worth reading once in a while.
Also the Elan / JnJ deal for their Alzheimer's pipeline -- 49.9 / 50.1%, JnJ gets control, Elan gets additional royalties on top of the 49.9% share in the profits (together, they own 50%, Pfizer owns the other 50%).
I laughed so hard my wife asked what was so funny. I said, it's not funny. Not funny at all. :0( ;0)
I remember you bringing up the micro environment last March. As I listened to the presentation I kept thinking, this is what FtM was talking about back then! Nice to get the details. It's like the universe on Orion's Belt in MIB. So small, filled with galaxies of complexities. My wife came in while I was listening and said, you should quit the TV business and study this stuff. Lord knows it was a tempting suggestion!
Agreed.
Thought the first might be of transacted rats. Might cause problems with animal rights groups. Still, one wonders...
Listen to Thorpe'S Presentation at 39:00 and following about inducing immunity. It's ... WAY cool. The whole presentation is eye-opening....
http://www.nyas.org/MediaPlayer.aspx?mid=25e51622-c908-46ef-bba1-95ca6a814eed
Nice. I'd rec the post if we had the function...!
In case you missed djohn's message, he posted the website for the New York Academy of Sciences conference, Targeting Tumor Vasculature and Reactivating Tumor Immunity with Bavituximab. The last talk was given by Thorpe. He detailed his research showing bavi's mode of action as it reactivated the immune system.
Bavi's no placebo.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77701118
Don't they tithe in Kentucky?
;o)
Loof,
I like the numbers, but I'm not ready to party just yet. Remember when the bottom line numbers came in for 1st-line back in March after great top-line in December? I think I need a chicken in the hand before I start counting my chickens. So...
If we're above a dollar...
$2 - 90%
5$ - 75%
$10 - 0%
$20 - 0%
If we're above $5
$10 - 10%
$20 - 0%
If we're above $10
$20 - 40%
If they pull another stunt like they did in March,
My family will be all right, but my wife will kill me anyway.
If we've gotten the stellar results we hope to get by then,
To infinity and beyond.
Agreed. If the numbers come in to justify AA and we get AA approved, the ramp will be historic in part due to off label use -- IMVHO.
Cancer groups are taking notice.
https://www.inspire.com/groups/lung-cancer-survivors/discussion/bavituximab-positive-trial-results/
After the 1st-line numbers came in on March 5th, the company downplayed the possibility of AA.
Now that it looks like the 2nd-line data is going to be strong, they are talking about AA as a possibility again.
They needed a home run to file for AA. I think they think they may have hit the ball out of the park.
Note Mojojo's post:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77520329
And at that time Peregrine and we will have to adjust.
If the question is one of modelling nearterm revenue, I'm not sure how that would affect PPHM whether they get approved next year or in three and a half years. How soon do you think the laws will change? I think, not so fast...
The first unwritten law is, if your drug is better, you don't charge less than your competitor, you charge more. The second unwritten law is, charge what you can when you can. If the law changes, that's life.
If the FDA approves it, private insurance and medicare/aid have to cover it. The system may be unsustainable (I really don't know but, it seems to me that the economics of the underlying assumption ought to be questioned insofar as economic theory is a political tool where people argue "truth" when, in fact, it's "better for me.") ... may be unsustainable but, if that's the case, when the law changes, Peregrine and everybody else will have to adapt.
I don't think it's going to change without substantial public debate (an all out brawl).
The missing data could be a red flag. I don't think it is. In the same room, Dew and I see different elephants.
I don't assume I'm right and Dew is not. We'll have to wait for the fall and see how things develop.
Wasn't approved for the entire population.
The FDA won't care. And if Pazdur and Hussain are involved, don't count your chickens. They are purists and turned the FDA against approving Provenge in 2007 when the Advisory panel voted overwhelmingly that it showed the necessary safety and efficacy to be approved. Over 70,000 men were denied the treatment option for the next three years. And there was a huge outcry. I even designed a bus add that ran in DC for a month after the decision criticising the FDA. Pazdur, Hussain, Scher, Flemming. They think they're right. They will look you in the eye and say they're sympathetic, then say no.
There's a difference between median and mean. It won't affect the median.
Breast cancer trial
Summer,
I believe all of the 40 patients in the control arm evented before May 21st.
HR matters. We'll see them a little farther down the road.
Yesterday's CC it was said that some in the treatment arm are still on drug. According to the protocol, that means some have not progressed yet.
Just came out in the PPHM board. Tho't it was ... fab, personally. In the advanced and metastatic trial with essentially the same treatment protocol, 11% of thse very sick women had complete responses.
Time will tell if it's me or Dew who can't see the forest for the trees. I have great respect for Dew but this time I think he, and you, are missing what is becoming increasingly obvious. This was a well designed trial and the results are impressive.
Stunning. We may get those CRs ... 1-4, my guess (my hope)!
As I said, I have the objectivity of a shareholder. My rosy predictions have only happened twice -- DNDN and ELN. Look what happened to them.
Play safe. I'm as certain as I can be that you will make good money with your shares. That said, we all must take into account the irresistible forces behind Murphy's Law.
Seeking Alpha Transcript for PPHM Earnings Call - Statistics
http://seekingalpha.com/article/724781-peregrine-pharmaceuticals-management-discusses-q4-2012-results-earnings-call-transcript?part=single
...we will be able to talk more about some of the statistics behind the results as we, again, the data matures somewhat. Especially, for the most meaningful endpoints, overall survival, progression-free survival. I think what has come through with this is I think there is a very nice trend toward the overall survival and the meaningfulness of that data. I think that's really what's driving the partnering interest, as well as our going into our internal planning on designing the Phase III study, which we do anticipate would have overall survival as primary endpoint. So I think that in addition, I think on the -- as far as the geography goes -- I mean a few things. As we've looked at the data, there is nothing standing out about any geography or subset of patients. They all seem to be favoring at this point the bavituximab treatment arms and that's held true throughout the study. So again, I think when we think about the results, it's really been clean across the board and really hasn't had any of those sort of issues where it throws a complexity in the Phase III trials. So very clean results. And again, we really look forward in the fall, where we've identified a couple of potential conferences to speak at and that will give us an opportunity to come out with a lot more color on the data.
So, hopefully, biostatistics later this year.
I think we could end up with double of that or even much more. But I have the objectivity of a shareholder.
If AA looks to be a real possibility, I might wait to sell. There's bound to be off-label use. I would think lots of it. That could be good or bad. It will be out of Peregrine's control. Bad decisions could be made...
On the other hand, we'll begin to see how big real world demand is for bavituximab for solid tumor cancers. A lot of information will be generated in just a few years after an AA approval...
(It strikes me that they're going to have difficulty enrolling the PIII/IV. Who's going to risk getting placebo when the treatment that has out shined the SOC by God-knows-what percentage is available at their local oncologist?!)
Too exciting to think about and I have to go to work. It's going to be hard to focus...
What was the total dollar figure Roche paid for Genentech?
Which franchise will end up being worth more, DNA or PPHM?
Risk adjusted? Ah, there's the rub...
I read an article (I think I posted it to the board way back) about how many, many times the published success of clinical trials cannot be replicated ever. Our odds look good for us, sure, that the results would replicate in PIII but, BUT ... Murphy's law rules.
And, IMO, (may God and Lafont forgive me for saying it), Wall Street is dirty.
We almost have a bird in the hand. We don't quite have it yet.
A deal is the only way to make sure the Cramers of Murphy's Wall Street don't find a way to screw us like they screwed Elan.
Something fair, preferably very, very large. My two girls will get their trust funds and all will be right (enough) with the world.
Seeking Alpha Transcript Posted
http://seekingalpha.com/article/724781-peregrine-pharmaceuticals-management-discusses-q4-2012-results-earnings-call-transcript
As you can imagine, with data like this, there are many things that we need to consider. One consideration is that should the data continue to trend the way it is, particularly in survival, it opens the door for potential discussions around a pathway for accelerator approval. At this point, all options are being considered by Peregrine working towards the most efficient path forward from a ]regulatory standpoint.
I'm not sure that the timetable can be narrowed down any better than Mojo did earlier, but I was astonished by the fact that the data was unblinded in May and not earlier. That was a choice bit of information. They've been aggressive getting the news/information/results out.
Similarly, the other thing about the call that impressed me: they were more forthcoming about details than I've ever heard them be before. Fifteen meetings, big pharma, chemo types with biologics experience, some non US companies. Want to preserve US rights, might not be possible...
Lots of juicy details to chew on over the next few days...!
I think they want the companies they're talking to to know they have competition. Bavituximab has the potential to be a monster. They know it. Other companies know it. Now, back to the negotiating table...
I don't remember the wording, but my sense was, if the MOS data turns out as well as it appears to be trending, they could file for AA.
That was my takeaway -- could file, didn't necessarily mean that they would. But the possibility is definitely there and, considering the way the data has been developing, the possibility is very real indeed.
The guy who spoke for Garnick the 1st time said they were going to look into AA as a possibility...
From my notes:
Regulatory Strategy
Pathway to AA if MOS continues …
That, to me, was the headline of the night.
:o)
Unfiltered notes:
couple of interruptions by my 3-year old... Oye...!
PPHM Webcast
Questions:
1. When expect bottomline data for ORR and PFS in 2nd line trial?
2. Have made decision on AA? If not, when will that decision be made?
3. Since trial unblended, can you disclose where we are at this point re: MOS for 2nd line?
4. Since ORR and PSF are the endpoints, need to wait for MOS to decide if apply for AA?
Exceptional data
Doubling of tumor response
50% improvement PSF
Median OS reached in
Majority patients still alive
Data well received potential partner
Should move to PIII
125K treatable patients
$1B
5-7 mos MOS
Bavituximab looking good
Surge in partnering discussions – 15 discussions face to face…
Position for Spring
Want partner onboard for end of PII meeting. Potential partners agree.
Cotara moving forward
8 bavi oncology studies
3 MOS results possible before year end.
Imaging program data 2012
Record revenue year.
Unprecedented backlog
Looking for options for capacity expansion #$%^&*()_
MOS from trial in 2H 12
End PII by end 2012
Partner on board by then
MOS NSCLC and
Imaging data
JOE
Busy for PPHM
Oncology
ISTs
Imaging
Topline data 2nd line
IIIb or iV who failed …
Equally randomized
Primary ORR
SeconaryPSF
OS
Safety
Independent monitoring
Unblinded in MAY
15 and 18% ORR vs 8%
PSF 4.2 4.5 vs. 3 MOS 40-50% improvement
MOS in control arm <6mos
Neither bavi arm reached, some still getting drug.
Will report when both event
Anticipate reporting this year at conference
Randomized
Schedules same
Blinded
Gold Standard
Part of Registration package
Both trials
No subgroup differences
Excitement in med community
Similarly designed trial likely have similar results and likely approval
Front line lung
Front line pancreatic
End of 2012 may have enough info to work out followup
Lung breast liver prostate colorectal
Looking for Mode of Action
Imaging Program
Demo can image
Several Apps envisioned
Monitor effectiveness of traditional treatments.
Regulatory Strategy
Should data continue to trend – Pathway to AA if MOS continues …
Want PIII to replicate but larger scale.
Cotara discussions progressing. Feel positive solution to design can be found.
PAUL
Financial strategy
Dual Model – manufacturing and drug development
Avid
Nondilutive revenue source.
14M from 3rd party customers RECORD
2013 demand increasing
Largest backlog in history
30M
7M in deposits to secure manufacturing schedules
Secure a less dilutive financing
AVID asset
Non convertalbe type loan in 20-30M dollars
Leveraging late stage pipeline as source of capital
May 21 partnering interests may lead to another source of capital for company.
Look to build more institutional ownership. Past weeks, shared story with 26 companies.
QUESTIONS
ROTH
US vs ex-US
Reserving for upcoming conference
½ US
Power?
Will provide level of detail medical conference
Analysis of subgroups?
Need data to mature … esp. overall survival.
PIII would have OS as primary end point.
Geography, nothing stands out.
Results clean across the board.
Identified couple of conferences in fall.
How data stack up against other drugs in development? Combo or synergies?
PD1 – and enhance immune modulation: We’re all going after different targets. Ours more upstream.
PS is the major modulator by blocking immune …
Others, potential to combine. Needs to test empirically.
Robust clinical trial, take away bias.
Data Set solidifying…
Both bavi arms had similar efficacy.
MLV
Triple Therapy? Possible.
Going to have the broadest potential use in the marketplace.
Good safety with targeted therapies, 2, 3 combos … major positive…
All-comer type studies…
Squamous cell?
Not included.
Earlier PII unfortunately, tumor grow around arteries. Bleeding…
Stayed away. Intregued but how get without toxicities.
Now larger safety base to work with, can go back. Probably with partner.
Post Radiation? Radiation flips, so target more available…
Radiation most potent exposer of PS. More drug exposure, synergistic antitumor effects.
Radiation kills, PS turns off the immune system…
7M, when recognized? Where placed on balance sheet.
Record that as cash, offset as deferred revenue make drug, then recognize revenue
JMP
Logistics
End of PII meeting in Q4
Make sense after MOS. Line of sight for MOS?
60 days in advanced. Haven’t requested yet. Want to wait on that a bit.
More OS the better, more comfortable…
But don’t need to wait for MOS to know trend…
Know what’s going on. Periodically updated…
Getting more and more secure in the data…
ROBERT
In car
More than enough data now to initiate meeting with fda
As matures, better
Excellent spot right now
Know what going to recommend exactly
Partner ? Global trial. Want partners input.
Extremely compelling as compelling PII as I’ve ever seen.
Partnering Meetings
Characterize if with large, us deal or non us deal?
Partners oriented chemo? Or immune?
Most partners large pharma active in oncology. Many, not all chemo. We want some biologics. Majority have biologics experience as well.
Want to maintain US rights, our goal. Don’t know if possible.
At least copromote
Most multinational
Some outside US
Cotara timing?
Goal … iterative experiences. So far discourse very effective. Goal = coming few months….
Then find Cotara partner…
NEXT FEW MONTHS
Monitizing manufacturing revenue
Non recourse loan?
Goal = less dilutive funding. Term, or structured debt. Interest only ? then interest and principle…
Goal = couple of months.
Actively pursuing. May have something to say before next CC mid September…