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.
Thanks ex for the response and thanks for your input regarding the broker no vote issue earlier today.
ex,
you stated:
Bio,
This is what I believe is the actual rule that pertains to our situation and its from the NASDAQ rules (see following link):
2251 Forwarding of Proxy and Other Issuer-Related Materials
edcpf,
I grasp the logic now. Thanks.
edcpf,
I believe if you read the section labeled
What are the voting requirements to elect the directors and to approve each of the proposals discussed in this Proxy Statement?
you will find that they explicitly state that broker non-votes will be counted as "no" votes and specifically count against passing the resolution.
North,
Is this what you were thinking of?
Old FTM Post
Thanks Mojo.
Mojo,
Thanks as always for your input. But I'm confused with your vertical blue line and your statement that the blue line you added shows the delineation of greater benefit between the trial groups and the control groups.
KT,
Great post. I agree with everything you said. Except one minor non-significant issue. I don't believe the announcement that there was a problem occurred until 6 or 7 am on black Monday (just going from memory; traumatic memory). Doesn't really have any bearing on the subject matter of your post.
Thanks KT.
If we are talking what is the "biggest" leverage then I would say its the performance of BAVI first and 2nd, the ability of this company to bring this double blind trial with SOC and placebo controls PIII trial to a successful conclusion without outside partnership funding. These are the two things that together will bring us the astronomical increase in value that a lot of us here expect.
For those interested the new guy that asked a lot of good questions is found at this website:
Rahul Jasuja
KT,
Along the lines of this subject, one thing I found very encouraging was around 31:30 in the webcast where Steve K. stated that almost all of the existing backlog is based on "existing" capacity. I interpret this to mean that there is going to be significant backlog/revenue increases by end of next year. Absolutely must be providing leverage in partner negotiations.
Threes,
Solid no BS post. Thank you.
IFU,
I completely understand how it is second nature for you to notice such things. I was actually trying (unsuccessfully as it turns out) to start a new conspiracy tack by showing how Peregrine changed its pipeline color scheme to one where the colors could have been extracted from the palette used by the BMY website. Implying the PPHM web designer must be using BMY's website as their new standard. Just a stupid attempt at messing around on my part.
Really IFU??? Complaining about colors?? Come on....
Here is a link to a well known BP and they use the same colors used in their pipeline chart.
??BP Pipeline Chart
I think you should complain to them too.
In case you didn't know I'm only joking around with you (well mostly anyway)
PG,
Its so disappointing to be reminded almost daily on this board how moral compasses vary so widely. Another Sunday and I'm expecting to see more examples of the lengths that the shorts will go to trash Peregrine. Last Sunday they seemed to mostly take a break so I'm betting they will be trying harder later today. What scummy attempts will we see today? New ID's showing up lately so I'm expecting some new angles.
ex,
I believe this link should be sufficient to address the issue you raise:
The Drug Shortage Crisis in the United States
Although not specific as to company names, reading through the entire article will IMO, back up Dr. Garnick's statements. The fact is he said stumbled not failed. Since when does stumbling = failed? You changed stumbled to failed and not too subtlety either.
Why does it appear to me that you seem to want to minimize Dr Garnick's credibility and importance to the PPHM story? My first disagreement with you was when you were posting about how "common and un-exceptional" (my paraphrasing of the intent of those posts of yours) his background is and that we are putting too much emphasis on his work history. Some people just can't hide intent as well as they would like.
I appreciate you sharing more of your thoughts on the subject.
Interesting stuff.
Thanks Wook. I learned that math while under federal tutelage.
pphmtoolong,
I heard the judge is Issac Parker. I think CSM's insurance company(s) are going to want to settle.
cheynew,
Again, THANK YOU for your responsible DD and effort in presenting real stuff!
CSM is toast. There is absolutely no comparison between the quality and content of the CSM filing and the PPHM response. (My layman's opinion of course).
This is the section that interest's me the most:
Using mathematical principles:
Multiplying both sides by -1
-1 * (NO APPROVAL + NO PARTNER) = -1 * (NO RISE IN SHARE PRICE)
Remembering that a negative times a negative is a positive and that NO is a negative, then reordering terms yields
Rise in share price - partner = approval
Thus proving that your words state mathematically that a partner is a negative and we will have approval and a rise in share price without a partner.
ex,
Thank you for providing experienced input on this subject. Much appreciated.
PDB,
I'm not sure where you get your logic from. The medical review committee made the recommendation to combine the groups and they are, by the rules of the blinded trial, outside of Peregrines influence for this process. Again, no more than 25% of the control and 1 mg/kg arms were affected so the impact you are implying would require what I believe would be a significant set of low probability occurrences lining up just right to say the 1mg arm was actually worse than the control arm.
Your statement that the MOS of the control arm was better than 1mg arm has no supporting basis and is in fact not supported by the data that is publicly available.
The real impact was having to give up the 1 mg/kg arm altogether and losing any chance of statistical significance using the larger population the combined arms would provide.
Some people keep trying to imply that the censored patients were a ploy used by Peregrine to skew the data. I'm not saying you did this in your post but the subject matter you are discussing seems to always end up with that discussion occurring.
Show me a trial for an end stage disease like 2nd line Non-Squamous NSLC with a 120 people that doesn't have censored patients. The Bavi trial percentage was slightly higher than the few trials that I researched at the time (including Avastins PIII that had hundreds more patients) but nothing that would have caused me undue concern. AND, the more salient point is that the INDEPENDENT medical review committee makes all the decisions on censoring. So unless someone wants to create their own conspiracy theories for the doctor's in the medical review committee and Peregrine conspiring to skew the data by censoring patients then I believe there is no basis to imply the censoring was improper.
Your statement of
Jakedog,
Thanks for your diligent input. Your points sound very reasonable to me. I'm thinking there is plenty here in the liver trial to be positive about. If you look at the supplementary Appendix provided in the sharp trial report from the NEJM article I linked to a couple of posts ago you can find descriptions of how the Child-Pugh scores are arrived at.
Supplementary Appendix
MM,
I was trying to look past the mean OS number and look at the longer term effects. To be frank, I don't understand the 34 dead and 4 alive label below the overall survival graph and how you and ex are interpreting it. To me, an MOS of 6.1 means that it took 6.1 months for 20th patient to die, and that the graph was generated with 4 patients still alive. I don't understand the statement ex made:
MM,
This is my quick review of the liver data. First, here is a link to the sharp trial data:
sharp trial data
Using the slides from cheynew's post:
Yopp Slides
Comparing class of patients:
Sharp only had Child-Pugh of A, The Yopp trial had A and B7
The Sharp required platelet counts of >60 x 10^9/l (60 x10^6/ml (mm^3)). Yopp trial allowed platelet counts as low as 70 x 10^4 mm^3 (ml)). These are the only things I can discern as differences with the handicap on the Yopp trial compared to the Sharp trial. To what degree this represents the medical community will have to weigh in.
The one thing that sticks out to me to be in the Yopp trial's favor is that the Sharp trial had 602 with none alive after 17 months. The Yopp trial had a lot less (38 patients) but 3 are still alive after (what I interpret as greater than) 18 months when looking at the curves on page 4 for number of patients at risk and the table on page 15. Again it looks like there may be distinct advantage to having Bavi in the mix. Anyone, please feel free to weigh in on this. Much appreciated if you do.
Ex,
Correct me please if I'm wrong but I believe because we have Fast Track that we have the ability for rolling review and with rolling review the FDA can make a decision for priority review based on the preliminary data submitted as part of the rolling review without having to wait for the regular package submission:
windandsea,
can't sleep tonight. I must be way too excited about Rudolph Garnick leading Santa King's sleigh to the island of misfit biotechs' trials so he can distribute Peregrine's Sunrise trial to the world .
I thought I'd but in here. First, I think MD meant months not weeks, but he'd have to answer that for himself. The thing I wanted to chime in on was the Opdivo trial that your post seems to imply is a standard which Bavituximab has to be measured against.
It was made crystal clear in the call and followed up by posts on this board, that Opdivo was approved based on squamos cell lung cancer trial results.
From the call transript provided by CJ-Post 209953
BioBs,
Thank you for the information. It has raised some questions that I would appreciate anyone's opinion on. First, from the clinical trials gov website for this trial the following is obtained:
Bavi Sorafenib trial info
Interpretation
Chronic liver disease is classified into Child-Pugh class A to C,
employing the added score from above.[1]
Points Class One year survival Two year survival
5-6 A 100% 85%
7-9 B 81% 57%
10-15 C 45% 35%
FTM, entdoc: Recapitulation
Thought I’d enter these names in the first line in hopes of getting FTM and/or entdoc to read.
I’ve been fixated on the “teaser” subject matter discussed in the cc started by Joe Pantginis.
It all revolves around how to assess the teaser discussion for interpreting how well the human liver cancer clinical trial headed by Dr. Yopp is performing, along with what new information is being provided on the Bavituximab/ sorafenib combo MOA.
Joe started the subject off by asking , “Okay that’s fair and then with regard to I know Joe mentioned maybe at SITC we would be seeing some translational data from the liver cancer studies, so I was just wondering if there is any potential teaser there…”.
Steve started the response string on this subject with “As far as the you know kind of a teaser, I think we've said right from the beginning that one of the things we've been looking for out of the number of the Investigator-Sponsored Trials are really the correlative data that goes along with the animal studies we've completed showing the – basically the symptom you know the symptomatic changes in the profile of the immune cells that are present in the tumor microenvironment and more broadly in the animals themselves, so that’s kind of data in general that of course we’re looking to present. I’ll let Jeff or Joe add a little bit to that.”
So Steve K kicks it over to the more involved science guy Jeff Hutchins to see how well Jeff can do the cc call dance. Jeff continues the PPHM response with “Yes, as Joe said really the teasers that we are seeing some consistency between what we first identified in the animal models as this increase in CD8 positive T-cells translating quite nicely with these liver samples (the liver samples from the human clinical trials analyzed I assume by PPHM or their agents –Nuke661 comment). Joe you want to comment for that.”
It now appears to me that Jeff is wondering how much he should be saying on this subject and wants to punt it up to Joe Shan’s pay grade and let him get in trouble for saying too much.
Joe’s response is the one that is most intriguing to me.
He says “Yes, I think the totality of the immune changes - of course the CD8 changes are interesting (Nuke again- now the CD8 changes are only “interesting” not really the big deal it seems) - but you know WE BASICALLY ARE RECAPITULATING ALL of the pre-clinical steps within the immune system changes within the tumor. So it’s more than just CD4, CD8, Treg for example there is a lot of information on it will be sharing.”
From my perspective, based on these exchanges, we should be looking at what has been published by Peregrine regarding the pre-clinical trials and should expect the human clinical trials to produce similar results. Here is a CJ post on the pre-clinical trial results from April (as always we can count on CJ for the majority of the wealth of technical information we have readily available to us for real due diligence): Pre Clinical Bavi/Sorafanib PR
The pre-clinical bavi+sorafanib yielded 69% tumor reduction over sorafanib alone. I would think that with human trials having the same immune system changes (“we basically are RECAPITULATING ALL of the pre-clinical steps”; remember that statement was made in regards to the analysis of the liver samples from the human trials) then why shouldn’t we also expect a significant improvement in tumor growth in the human trials.
FTM and entdoc would you please provide an opinion on this assessment of the meaning of “recapitulating all” of the pre-clinical steps. Would this include tumor growth data or just the immune system changes?
I’m not sure how we should interpret the pre-clinical data of “less tumor growth”.
To me this means the tumor grows less rapidly but does not necessarily mean that it reduces the size of an existing tumor. I know that ORR is based on reduction of existing tumor volumes/sizes and ORR is a big surrogate endpoint for accelerated approval for NSCLC (FDA Doc on NSCLC Endpoints ; but where does “reduction of tumor growth fit in” in the big scheme of things?
I would appreciate some of the knowledgeable medical people on this board provide some guidance in how to interpret the “less tumor growth” term used by Peregrine in the pre-clinical trial PR in the link provided above.
To me it certainly looks like they want the world to tune in for the information they intend to present at SITC regarding MOA and data from a Bavituximab/sorafanib combo treatment in humans. They are drawing a lot of attention to the November SITC so they must want people to hear it.
IMO they are using very encouraging words describing what they are seeing for the liver trials; multiple times providing positive descriptions on the same trial that I haven’t heard since the phase 2 NSCLC trial statements prior to the retraction in 9/12. They have been so subdued since 9/12 regarding human trial data that it’s got me wondering what’s coming. And for the persistent naysayers, before you have a chance to say it, I feel pretty confident that it isn’t a train’s headlight either.
Another reason to have a good understanding of the scope and breadth of the Peregrine PS Patents:
Source
Wook,
I saw this video yesterday while surfing and before my wife put me to work. I saw the Nivolumab label and discounted it being Bavi. I just assumed there are more cell surface targets other than just PS that can have a basic MOA description similar to Bavi. If it is PS they are targeting then they certainly weren't broadcasting it. Notice they weren't specific in the video regarding the target.
I thought it might be PS targeting experiments by a BP to check PS out themselves using patent loopholes for research. This is just a wild ass possibility line of thinking I had because the MOA for Nivolumab doesn't sound anything like what was described in the video and there is nothing directly connecting the label on the IV bag directly to the drug being discussed. They never said what the drug was and only provided the MOA cartoon.
Nivolumag MOA Info
Source
Wook,
I believe the drug is listed on the IV bag label at 2:50 into the video; if this is the actual drug used in the trial being discussed.
Correct
Just for general info. I wanted to see if there was any appetite in the pphm market for acquiring shares. When the stock was stagnant earlier in the 2.24.. to 2.25 range I placed a 10,000 share limit order at 2.28. The market came and got it in less than 1 1/2 hours.
PGG76109,
Thanks for that link to the HIV poster info.
Anyone have an educated/knowledgeable insight regarding the possible importance of the last sentence of the conclusion section:
"Incidentally,we have developed a Master Cell Bank (MCB) of a cell line that stably expresses PGN632. mAb from this MCB was also able to neutralize HIV-1 in vitro to the same degree as reported here (data not shown)."
Is this making a statement that the mAb can now be produced much easier? Meaning cheaper and in far greater quantities per production run? Is this saying there is now a manufacturing capability that can produce a strong HIV-1 inhibitor for a "small??" fraction of what previous costs were? Or is this just a statement they have the capability to produce the mAb in quantity in manufacturing runs and implies nothing about the cost?
I would appreciate anyone who can interpret this for us to do so.
Thank you.
BioBS2012,
Regarding item 1 of your post; it is clearly the intent of a phase 2 to prove some amount of efficacy to support going to phase 3 trials. The following link is to a presentation on the design of clinical trials given by a professor from the Medical College of Wisconsin and it clearly lays out the purposes of the different phases of clinical trials.
Designing Clinical Trials
The purpose of PII to show some proof of efficacy is clearly shown at about the 9:57 mark in the presentation.
Therefore, all the noise regarding that the FDA only allowed Bavi to proceed to Phase 3 because it is safe is just wrong.
This presentation makes it clear - to me - that performing a double blinded placebo controlled vs standard of care trial in Phase 2 with a patient size of 80 in treatment group (size of our combined treatment groups if not hosed by the dirty deedsters in Fargo (Dirty Deeds - don't click this link if you are adverse to AC/DC )) stood a high probability of leading to AA with the data that was developing. It is also clear to me that Bavi more than met the standard criteria to move to Phase 3, The FDA didn't just allow
progression to Phase 3 because it was only a placebo and safe and therefore didn't represent any fallout risk to the FDA. That type of talk is pure ignorance of purposeful fabrication.
I always wondered about the possibility of insiders at news release organizations being able to trade on or, pass on to others, news not yet made public. Also, how much lead time do they have relative to the general public. I know that most of the Peregrine releases come from PR Newswire so I searched the internet for info. I came up with the following link:
PR Newswire Info
At the very bottom of the page it states that a minimum of 1 business day is required for a news release to be submitted and in PR Newswire's hands prior to distribution on their iReach system.
Just thought this may be an interesting bit of info to have. I'm sure a lot of you already know this, but I didn't and I'm sure there are others that also don't know this.
If Zare's prediction is correct for the news release after closing of trading hours today, then PPHM would have had to submit the news release to have it in PR Newswire's hands by opening of business this morning.
dia,
just to add to your info, SK said this at the Wedbush conference:
"Again we like this combination paclitaxel again as a part of the same family that docetaxel are known to be immunostimulatory. So we certainly think this data supports moving forward at some point in future with another breast cancer study. Another study which has gotten a lot of attention is our liver cancer study in combination with sorafenib. again sorafenib very recently was shown to have immunostimulatory effects.
And so again a good combination early data from the study looks very promising. We're hoping to have more data from the study towards the end of this year early next year. As I mentioned we're also running a front-line study in combination with another chemotherapy pemetrexed. We expect data from that again towards the end of this year early next year."
http://www.earningsimpact.com/Transcript/82836/PPHM/Peregrine-Pharmaceuticals---Wedbush-2013-Life-Sciences-Management-Access-Conference/Page/6#sthash.VO3Bl2ay.dpbs