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.
We're very sorry, but the storm forces us to end Q&A. Official business of the meeting concluded prior to the outage. We invite shareholders to submit additional questions to the e-mail2016ASM@interdigital.com. Answers will be posted to interdigital.com
I also like their comment:
The company will pursue a clinical development strategy focused on conducting small, early stage studies of bavituximab in combination with I-O agents...
I understand by this that patients will be early stage in their cancer?
If so results can come faster and maybe Bavi's efficacy can be more easily tested. Hope so
Anyway I liked the PR... Their approach seems sensible and WStreet should prefer it to the uncertainty the Sunrise Halt produced
S. Worsley from last CC in March:
Stephen Worsley
Thanks, Joe. As Joe provided an update on our collaborations with AstraZeneca and the NCCN, I’d like to provide an update on Peregrine’s other I-O-focused collaboration with the Memorial Sloan Kettering Cancer Center.
The goal of this partnership is to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments.
This work is advancing well. To-date, we have seen initial signs of activity with new combinations with bavituximab and other treatment modalities such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend the next year investigating these possible combination potentials. We are also renewing the contract for next year as we’ve seen exciting results thus far.
Things shouldnt have changed that much in the last 2 months
I find this post most interesting. At least for those of us who still have some hope in Bavi
thank you aikifredicist
After receiving progenitor cells, he started again. He found 173 drugs blocked caspase-3 increase, about three dozen did so without harming cells, and one — just one — prevented the Zika virus from killing cells. That drug, which he declined to identify, is not approved but has undergone safety testing and is in a clinical trial with cancer patients, he said.
So which drug is the lucky one? Should this drug have some value?
Let's see:
- Is NYTimes a reliable source? I believe so
- What about Dr. Zheng? Reliable? Why not!
- The drug is used as antiviral + cancer
- Immuno drugs should play those two fields too
- And there are immunodrugs in clinical trials
- BUT is there any immunodrug with a safe profile? Dont know of any but who am I?
Anyway, Wonder why so few people have commented on the post
I also remember a few weeks ago a rumor about Zika and Bavi made PPS jump! Was it because someone knew about this article and thought it could be Bavi? Or something else?
Nice to know I am not the only one (sorry! )
Interesting Post, thx djohn...
More from LinkedIn
Sharyn Alcaraz
General Counsel
...
Chairman of the Board
Pacific Health Corporation
March 2014 – February 2016 (2 years)
Solely responsible for the auction/bid process for divestiture of all assets (act as M&A advisor to the company, sole interface with all prospective purchasers/bidders); negotiate all asset sales; manage deal process and manage outside counsel on drafting of purchase agreements
But as you can see "Placebos" do wonders... Just take a look at what happened in Sunrise
So, are you ready to make another of your forecats? I keep a good record of them
I just hope (if you do) that you will stay behind your statements whichever they might be
Thx EX for your contributions. I just wonder if you would change your mind on the subject IF Bavi was found in the Placebo Arm Patients.
It happened once why not twice.
Hard for me to understand the Placebo Arm behavior... The Opdivo explanation: I dont buy it... Most patients were from Europe and most, most of them had no chance for Opdivo
Danny, I like your down to earth thoughts... unfounded wishful thinking can be our worst enemy.
I tend to agree with most of your reflections. And though I am not sure it was Dart (or not) who paused the disaster, it clearly had to be "somebody" who somewhat controled the trading that day.
I guess some hope is still left
Thanks for your insight, like always very appreciated.
J
No link... Just my own source of info... Which by the way I also shared with you a few months ago.
Need for a DMC (From Wikipedia)
<<Many randomized clinical trials are double blind – no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized.
Clinical trials may go for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. The DMC is a group (typically 3 to 7 members) who are independent of the entity conducting the trial. At least one DMC member will be a statistician. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects. Ethicists or representatives from a patient advocacy group may be included, particularly for research involving vulnerable populations. The DMC will convene at predetermined intervals (three to six months typically) to review unblinded results.[citation needed] The DMC has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.>>
So, given that Sunrise Hospitals were requested to send their Sunrise reports by begining of 2016 (say they were sent / received by end of January)... Also, it is logical to assume that their "predetermined" meeting would take place once the DMC members had had the time to read and analyze the data (2 / 3 weeks at least?) and not before that. Or in other words, regardless how many events might have already taken place, there are reasons to believe that that meeting would not have happened yet or is about to take place.
It is also reasonable to think that the amount of data that those reports should provide will be enough as to determine "green light" or not... also regardless the 155 events needed for the 1st look-in happened or not... which I believe they happened (unless Bavi Arm goes to astronomical MOS)
Cool video DNODD, thank you And interesting info as well
I am not too sure about that Paul.
Hi EX, I may not understand your question because I don’t see the issue...
My apologies for shocking you Danny
Yeaah! It seems like the FDA would not have hired Mother Theresa!
Cruel, mais c'est la vie! LOL
Now seriously, even from PPHM's perspective I am not sure it would make sense for them a halt at first look-in... If they want SOC, at least they should know which MOS corresponds to the Placebo Arm... a trial halt then would not make possible to know that number.
Summer time is fine with me.
Hey! a few C.C.s back... Garnick, SK et all made sure our expectations should go to 2017... (when the Bavi commercialization & approval calendar was explained in detail)
Time line was set at that time, so everything happening before that is a bonus for me.
Nice thoughts Danny, wish they become true.
However I have my big doubts about getting Bavi approved at the 1st look-in.
If 156 events are needed for the 1st look-in and let's say that at 1st look-in Bavi Arm had only 20 events.... you are right that the 136 to 20 ratio may be there (and it is outstanding to say the least!) but the Placebo Arm would need 167 events to mark its Median. Not to mention the other statistical parameters that seem to have to be considered for a proper statistical measurement of the trial procces.
My idea of the FDA is of a merciless and cold agency that would not take a step outside the established protocols unless some political pressure steps in. So I doubt the trial would be stopped at that point... However in mid-April the Placebo Arm could have passed the 167 events which at least would have established its MOS.
I dont know if such a review can happen between look-ins. I am afraid we would have to wait until 2nd look-in, where with a possible ratio of 203 to 30 and the rest of statistical parameters in place... I believe the FDA will do something about it (around July?).
Not only that CP. From the Opdivo trial we know there were only 5 censored patients within the first 15 months, a number I find very small or insignificant.
After the 15th month there was a total of about 17%... rather uniformly distributed amongst the 15th mont till the end.
So not taking into account censored patients would not make much of difference to the numbers you estimated
JQ thanks for your post, let me reply to you (from my point of view)
I agree that we are basing our calculations on two basic assumptions:
1. The enrolment model based mostly on the dates Hospitals signed in for Sunrise. The resulting curve is a "hockey stick" type as expected from Shan and the start and end points of the curve are the same than the real one. The error I think can be acceptable
2. Statistically speaking, the Placebo Arm will behave similarly than the Placebo Arm at Herbst et all trial, where patient population were same number and type.
The methods applied to these assumptions were different. And in my case I DID take into account the dropped out numbers. These data I got them from the Opdivo trial which I find quite similar to Sunrise (see chart below)
Now. Am I stating that these numbers will be accurate? NO! But, if statistics are good for something they can give us some sort of order of magnitude. Of course all in my opinion (my humble opinion actually)
But I appreciate any comment that can help improving the numbers. And as Golfho said, hey! this is just for the sake of making predictions while we wait. Noone should make a buying / selling decision based on this. I dont know about the others, but I have no experience in clinical trials and there may be unexpected "things" (like the Sabotage ... ughh) that we may not be aware of right now. I am just an engineer who has some experience making calculations outside the clinical realm. So anyone who can point out to whatever that might have been forgotten please let us know!
Ok ChB, just for the sake of keeping a nice chat alive, these are the 1st look-in projections updated with the latest info.
For a 9.9 MOS Doce-Placebo Arm. Now you can take your pick for the number of events needed for the 1st look-in. The chart shows for a 152 events 1st Look-in
And it goes from beginning of February (13MOS Bavi) to mid March (17MOS Bavi) (BTW, I also believe there might be 1 month gap from the events happening - to PPHM acknowledging them, so 1st look-in might have happened though not yet acknowledged). The model takes into account dropped-outs… a 17% censored patients starting from the 15th month and evenly distributed onward. Otherwise, if censorship would not have been considered 1st look-in should have already happened (according to this model)
I should add that while I think that the “eventing” distribution chosen for the Placebo Arm may not differ much from reality, I am not sure about the “eventing” distribution assumed for the different cases for the Bavi Arm (13MOS, 15MOS & 17MOS). The Median for those cases correspond to the label but the month to month eventings have been chosen trying to resemble the curve from Herbst et all but I know that this is no guarantee of getting a precise projection. And the higher the MOS the harder it is to tune in the results.
But coming back to Sunstar’s comments about a 20MOS for Bavi… I find very possible that right now the number of events from the Placebo Arm are double than Bavi’s, which may indicate a rather high MOS.
I said I just find it possible, I am not betting my farm that I am correct… I hope nobody makes any buying decision on my pure speculation Please!.
No harm in accepting an opinion... Accepting it does not mean believing in it
Anyway, as the saying goes: There are lies, damned lies and statistics
But, hey speculating is more fun than reading negative stuff about PPHM, at least for me
Yes N4K we are somehow speculating... BUT do not forget that while the Bavi Arm behaviour is an unknown, we have an existing study so that we can expect a quite precise statistical behaviour from the Placebo Arm (the results from the Herbsts' et all trial)
So estimating the events from the Placebo Arm at any given time, given what we already know from the Enrolment Curve... Well it will not give us exact data but for sure a decent enough order of magnitude.
So I repeat that I believe that the Placebo Arm has already reached 100 events.
I know it is just my opinion, but I think I can back it up.
Thanks CP for your thoughts.
Just a few comments to your post. You talk about 582 enrolled patients but I don’t think that there are that many, something like 542 (582 x 0.9) plus only. Around 560 at most? But I don’t think that this really matters right now.
The following may have nothing to do with your post, but I would like to make a comment regarding the enrollment curve and how close our projections would be to reality. If it is a “hockeystick” type of curve and (thinking of the chart), we do know the starting point of the curve, we do know its end point (560 after that many months) and the type of curve it is… the error from assuming an enrolment curve (based on the starting date of the Centers involved) should be quite acceptable. I know this has nothing to do with your comments but just saying
Thanks Sunrise for the info.
I find it a bit unfair for the Sunrise patients, but "c'est la vie"
I think there are good reasons to be optmistic.
Thanks EX for your reply.
Thank you Golfho for your detailed explanations.
I find interesting what you said
Sorry EX, I dont exactly know the method used by Golfho, I used my own eventing system (probably similar to his, but I dont really know).
I just based my enrollment method on his.
When I have some time I will take a deeper look at it, but I guess he is the one who would know better.
And yeah, I agree with you that these simulations and reality may be far apart.
Too many assumptions that can be wrong... And depending on how wrong they are our calculations will be close enough or not.
But I dont think anyone will bet his farm on this... It is just a guessing game, something to play with while we wait...
1st Look-in Projections Updated
This new update takes into account:
- Complete Enrollment by end of January (instead of end of December 2015)
- Dropped-outs Statisitics also considered (censored patients Chart provided by Mojojojo )
- 1st lookin happens on 1/3 of 80% eventing (155 events) as per RRdog # 251028
- Eventings distribution follows Herbst´s trial (already considered in last update). Placebo arm 9.9 MOS
According to the assumptions taken for the calculations (see also below), 1st Look-in would happen:
- For a 13 MOS Bavi Arm: 2nd half February
- For a 15 MOS Bavi Arm: 1st half March
- For a 17 MOS Bavi Arm: 2nd half March
ASSUMPTIONS:
Enrollment (Golfho's model updated)
Eventinsg Distributions per Case: (based on Herbst trial results)
Herbst´s Trial (for assumed eventing monthly distribution)
For Censored Patients / Dropped Outs data (thanks to Mojojojo)
Early dropped outs insignificant (see red arrows)
AMD extends license agreement
AMD Extends Patent License Agreement with Rambus
Agreement extended for a third five-year term
Rambus Inc. (NASDAQ:RMBS) today announced that it has extended its patent license agreement with Advanced Micro Devices, Inc. (NASDAQ:AMD). Under the terms of the agreement, AMD will continue to be licensed for its integrated circuit and circuit board products for an additional five years. Specific terms of the agreement are confidential.
“We are pleased to have reached agreement with AMD for this extension,” said Luc Seraphin, senior vice president and general manager of the Memory and Interfaces division at Rambus. “This extension represents the third continuous agreement we’ve signed with AMD, which showcases the continued value our IP provides to the industry.”
Rambus develops enhanced, industry-compliant chipsets, custom memory and serial link technologies, and services to address power, performance, and capacity challenges for the mobile, connected device, and Big Data cloud computing markets. Rambus also drives innovations in silicon to cloud security and computational sensor technologies, making digital products safer and better.
Follow Rambus:
Not the transcript, but I believe I still keep the recording of Dr. Thorpe's speech in my computer.
I wouldn't mind sending the audio to you if so you wish (and indicate an email address where to send it to)
EX you may be right, however when Dr. Thorpe spoke at the NYSA a few years ago, and when someone asked him about Bavi vs leuchemia, though he said he actually did not know... at the same time he explicitely did not discard the possibility that Bavi could also work for non solid tumors
I can't believe that. Outrageous! EOM
That would make a nice sticker... Thanks CJ EOM
Magnificent essay MH, thanks EOM
Wow! It doesnt seem fair for the trial... Just imagine, as I said, that there is a 40% of dropped outs... Maybe it is not likely but nonetheless possible...
Then reaching 192 events may take ages... Using my model, it is like instead having a 582 patient population we have 582 x 0.6 = 350 "enrolled" patients. For a 15months Bavi MOS we may have to wait well into the summer.
Any idea of which could be a reasonable percentage of dropped outs?
anyway thanks for your reply
Thanks Mojo for your reply,
The question about how to deal with patients who step out of Sunrise still remains unclear. I called them “censored”, but that is not exactly the right word. I know that there are patients who have voluntarily stepped out of Sunrise for whichever reason (not necessarily because Bavi is no good).
Let’s suppose that 582, as you said, is the magic number. And let’s also suppose that PPHM knows that a number “D” of patients have dropped out Sunrise.
a.)Will all known dropped outs be overwritten as enrolled and be replaced by new enrolled patients, so “582” remains regardless of the dropped outs?… Or
b.)The number of Sunrise participants will consistently decrease as dropped outs increase and therefore it would always be (582 – D) participants. In that case it wouldn’t make sense to apply the 33% (for the 1st look-in) to “582” but to (582 – D). i.e. (suppose) there is a 50% dropped outs it would take ages to arrive to 582 x 0.33
If (b) is the case then the model I made is not taking into account the number of dropped outs and therefore giving a greater number of eventings than in reality. Then dropped outs should be taken into account in the equation which would mean that all along the enrolled patients should be reduced by a percentage of dropped outs (15%?)
It would be interesting to know if it is a) or b). I wish it is a).
I would appreciate if you or some other expert on the board has an answer.
Elementary Dear Watson!
166 x 3 = 498, so the 3 in the 300 is a typo that meant to be 5