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A comment and a question:
As a result of the Sunrise trial being discontinued, the internal focus at PPHM has changed dramatically and rapidly and now Worsley has indeed become a much more important player much sooner than an AA after first or second look-in would have required. But as mentioned many times previously by varied posters, the silver lining of all of this is of course a much more focused and rapid move towards partnering with numerous other large I/O players - with AZN still apparently maintaining the "pole position" in terms of inking the first $$$ deal.
Regarding that "first deal" - one member of our group asked me this weekend if anyone had responded with any type of prediction regarding what would happen to PPHM's market cap upon the announcement of that "first deal."
I had to tell him that I had not yet seen any responses - but would post the question one more time.
Have at it folks : )
James
bfiest, you are most certainly NOT ALONE in your opinion.
The Need For Speed has been fully realized and efforts - as CP describes - are moving towards fruition.
Thanks for your thoughts.
CP, thanks for your three posts this morning - I have a question for you. In light of the tremendous and very disruptive potential you intimate Bavi could represent - then why - of course in your opinion - hasn't a large BP - to date - made a move to acquire or at least gain exclusivity via partnership of such an incredibly important piece of IP?
Just for sake of discussion - I return to GILD - they made it clear some time ago they wanted to move aggressively into the I/O field - but to date not much has happened in that regard - they even made it abundantly clear that they were looking for that "Cornerstone Molecule" on which to build a new franchise in the I/O arena. So with all the information now available - and with more seeming to come out weekly - such as Hutchins presentation today entitled, "Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of Phosphatidylserine (PS), a Novel, Global Immune Checkpoint" - what in your mind is preventing an entity such as GILD from making a serious move on the IP?
CP, I'd like to get your impressions on the "who needs who more" question I posed to Paul yesterday.
Here is the full post.
Tradero, yes, that was the graph I was looking for. Thank you very much.
James
Sunstar, nice post - we concur with your reasoning. Regarding your statement below:
Paul, thank you for your response reprinted below:
Unfortunately, I believe you are wrong on many fronts - so I'm not quite sure how to respond - but please note Jake's response to your post below - as he and I agree that "time is indeed of the essence" at this juncture - so, as SK spelled out quite clearly on the last CC - PPHM is now working diligently with world class partners to "get the show on the road" so to speak - and as such, partnerships will be coming soon - with AZN now clearly the first and very logical choice if they wish to have any hope of catching up to - and possibly passing by - BMS and Opdivo.
And just as an aside - for sake of discussion lets assume my prior statement is correct - then think for just a moment about the relative LEVERAGE each party brings to the negotiating table - In short - Who needs who more?? I think a good argument could be made that AZN needs PPHM - and of course Bavi - more than PPHM needs AZN. I only point this out to demonstrate that some pretty good terms - from a PPHM standpoint - may still be quite reasonable to achieve - and both parties will want to reach that deal ASAP.
One other point to keep in mind {and as I'm sure Entdoc would agree} - the bar is still extremely low in NSCLC - so if you put ANY WEIGHT on Dr. Brekken's research, then a Durvalumab plus Bavi combo could very easily not only blow away the Opdivo SOC of just 12.2 months MOS - but would very likely dramatically increase overall response rates as well.
James
toolong, thanks for your response:
toolong, re your statement below:
Ent, thanks for your thoughts - good to talk with you again.
Chris, I'm just wondering why all the continued "speculation" about what happened with Sunrise. As I mentioned previously, Dr. Garnick et all is now reviewing all the data - and when he is finished, he will tell us all conclusively what happened. Again, this was HIS TRIAL, so he will get to the bottom of it - and soon. And if there are "IRREGULARITIES" discovered - you couldn't ask for a better advocate to go directly to the FDA to clear things up. Remember, most people have to wait on the FDA for a simple return phone call - but with Dr. Garnick's history and background, they take his calls immediately.
PPF, We'll know soon enough.
Re: Dr. Garnick,
Bungler, it may be painful right now - FOR ALL OF US - but of course unless we actually sell our shares - we {you} have no realized loss YET.
Bungler, seeing your uncharacteristic and quite numerous posts from today - which concluded with the following - I'm glad you had the opportunity to vent - We're all frustrated but, as many have stated, nothing has really changed - EXCEPT for PPHM's ability to "go it alone." And maybe that's a good thing - because time - particularly in the I/O space - is now most certainly of the essence.
MH, just thought about it and realized that Opdivo was compared to Doxe alone - no combo - sorry for the mistake. But the question could still have some merit - at least insofar as the AE aspect of the evaluation.
James
MH, thanks again for all your valuable contributions. I'm sure they are appreciated by all.
A question - Opdivo/Doxe gave us a 9.4 MOS vs 12.2 for the Treatment Arm - which was observed prior to completion of the trial - but then prompted the trial to be stopped early which then lead to a very rapid approval via an AA.
Discounting for the moment the "dramatic" over performance in our very similar trial of the doxe cohort, what would you opine the FDA would do if Garnick et al can merely demonstrate to them that our Treatment arm was providing an MOS of AT LEAST 12.2 or better - which I would think is not an unreasonable assumption in lieu of the fact that PPHM just told us that the Treatment Arm was performing "as expected." And then before you answer, please take a moment to think about and contrast the safety profiles for Bavi vs Opdivo. The AE's associated with the Doxe component should of course be equal - so if both treatment regimens resulted in a similar MOS - and both include Chemo - which treatment would appear to be superior? And which treatment modality would a patient choose if provided with the safety and AE profiles for each drug?
Thanks again for your inputs.
James
Hello there Mr. Winners, you posted as follows:
Hello Eric, just a very simple question:
What is the point of you being here ??
Inquiring minds want to know.
James
gpuppy, thank you for your informative post which I have excerpted in relevant part below:
jbain, I think you sum it all up quite well in your post below - PPHM has achieved everything they set out to do - in Sunrise they saw the results they had hoped and planned for - only to be blown away by a Control arm that broke all MOS expectations and prior records for Doxetaxil - keep in mind once again that Opdivo was granted an AA just last year based on a very similar Doxetaxil control arm in their trial which achieved a very respectable 9.4 month MOS - if we had merely had the same Control Arm as they did with Opdivo then we might have an AA in process as we speak - particularly if our results showed an MOS of greater than 12.2 months - which was the number the Opdivo/Doxe Trial achieved. So I guess I'll reluctantly have to say I'm pleased that Sunrise has been unblinded - because now what does the FDA do if Garnick can show them that the Bavi/Doxe treatment arm was showing an MOS greater than 12.2 months - say 13.2 for example ???
And regarding Bavi’s potency in the I/O arena - as I believe MH stated a while ago - there are folks out there right now who are much smarter than all on this board - i.e. Birge et al - who now firmly believe in the science and will shortly be going on the road - literally - to tell the story.
So indeed nothing has really changed - with the obvious and perverse exception of the share price being ARTIFICIALLY CRUSHED - at least for now.
I keep thinking about old Joe Sixpack - and his recent warnings regarding “getting rid of retail.” If this recent course of events - I’m trying very hard not to call it ANOTHER act of Sabotage - turns out to be just another part of that strategy, I guess I won’t be surprised. I just hope Garnick - or someone - can prove it.
James
Jake, thanks for providing the link to the article - "Rivals chase Bristol-Myers in cancer immunotherapy drug race" - partially excerpted below:
To the Board in general - I resist posting this question, but one of the "old birds" in our group, who does not spend time on chat boards, has asked me to - so here goes - and playing off of geo's post as excepted below:
CP, in your recent post you stated in relevant part:
Jake, that truly was a great post - I would hazard your best one ever.
And thanks for posting the link to the article discussing the results of the Opdivo vs Doxetaxel lung cancer trial from 2015.
It's interesting to note that the trial was stopped early and then Opdivo was approved in an accelerated fashion after showing a 12.2 vs 9.4 month survival benefit. And then keep in mind that it appears Bavi in our trial was showing at least a 13 to 14 month benefit - but somehow {MIRACULOUSLY} Doxetaxel was performing equally well - despite NEVER having done so in any trial going back for at least 15 years !! - see FTM Chart from 2011.
Which then would indicate that if our Doxetaxel Control Group had simply performed in a similar fashion to the recently conducted (in 2015) Opdivo trial we would likely be looking at an AA right now - and similarly, if the Doxetaxel Control Group in the Opdivo trial had simply performed as our Control apparently just did - then the Opdivo Trial would have been stopped for futility at its first look-in. It’s amazing how this works. : (
But good post.
James
MH, re your post, excerpted in relevant part below:
The Other Guy
You may wish to reword your post
Sunstar, It would appear that you are giving the data shortly to be released regarding Sunrise first look-in a very good chance of yielding possibly quite "Spectacular" results. Now what was it Dr. Garnick said could happen should this be the case? : )
Danny, CP, et al,
This Wikipedia "editing" thing is GREAT !!!
And I'm not kidding - just think about it. NO ONE on this board - or any serious investor for that matter - would ever be too concerned about what may or may not be posted on Wikipedia. Now don't get me wrong, Wiki is a valuable resource for many many things - but most likely not the best place to do your DD on PPHM, Bavi, or even PS in general.
But it is a very likely place where many individuals - after hearing some BIG NEWS on a new cancer therapy - may find themselves - at least initially - as soon as they begin their google search in an effort to quickly try to learn a little more about the topic(s).
Therefore, what this logically says to me is that someone is expecting NEWS of a very important and substantial nature is coming - and coming soon. So if someone wants to "slow down" {if even for a very short while} the general public's understanding of the science, but more importantly - and at least from our "editors" standpoint - diminish the excitement in the general investor community - this would be one small thing that could easily be done that would have, at least in a minor way, a short term chilling effect for many potential NEW investors.
Shorts do have to cover - don't they? : )
Enjoy the rest of your weekend.
James
CP, re the article I posted yesterday - and your comment excerpted in relevant part below:
http://www.huffingtonpost.com/entry/promising-therapy-sends-93-percent-of-incurable-cancer-into-remission_us_56c3cbf5e4b0c3c550531fe5
New Cancer Therapy Could Give Hope To 'Incurable' Patients
This could be the future of cancer treatment.
02/17/2016 04:58 pm ET
A new experimental treatment has achieved what chemotherapy and bone marrow transplants have failed to do: put chronic, relapsing blood cancers into remission.
What's more, it uses the body's own natural defense system to attack these cancerous growths.
The treatment involves T cells, a type of immune cell that works as your body's own personal S.W.A.T. team to detect, surround, and destroy foreign invaders like bacteria or viruses. Historically, cancerous cells have grown too fast for T cells to mount an effective defense, and they can also trick T cells into thinking that they’re a healthy part of the body as opposed to a cancerous growth that needs to be stopped.
But in experimental treatments at the Fred Hutchinson Cancer Research Center in Seattle, initial evidence shows Dr. Stanley Riddell has successfully trained these T cells to better recognize and eliminate cancer cells in a short time span, allowing cancer to go into remission.
Specifically, he extracted a person's T cells in order to prime them to recognize the type of cancer that is affecting the patient, allowing these primed T cells to attack the growth while sparing healthy cells and tissue.
The results
Riddell's preliminary findings on the success of T cell therapy to cure previously terminal cases of cancer made a stir at an annual meeting of the American Association for the Advancement of Science in Washington, D.C. on Sunday because of his eye-popping results: 93 percent of the small group of 29 participants with previously incurable or constantly relapsing acute lymphoblastic leukemia have gone into complete remission after undergoing Riddell’s immune cell therapy.
An additional 65 percent of 30 participants with non-hodgkin's lymphoma have also gone into remission. And while it’s too early to report the results of a small test group of 15 patients with chronic lymphocytic leukemia, Riddell says that they’re also showing “really high" remission rates. In total, Riddell has treated nearly 100 patients with the T cell therapy.
"These were all cases that had failed all conventional therapy, so they relapsed after chemotherapy. Many of them had relapsed after an allogeneic bone marrow transplant or they just weren’t considered candidates for a transplant,” he explained to HuffPost. "To take an experimental therapy and use it in patients that are this advanced, and to get these kinds of results, is really encouraging."
The T cell treatment is the result of a 10-year collaboration with Dr. Michael Jensen of Seattle Children’s Hospital, who is currently conducting trials in children with leukemia and getting similar results, said Riddell. The effect appears to be long-lasting, and could provide a way forward for developing therapies for the more common and harder to treat diseases like breast, colon and lung cancer.
How it works
Riddell withdraws a patient’s immune cells in what amounts to a simple blood donation. Then he takes a few weeks to link synthetic receptors called chimeric antigen receptors to the T cells, in order to help them identify cancer cells in the body and destroy them. Once they're re-infused back into the patient, Riddell basically sits back and lets the T cells do their thing. It generally took about 30 to 60 days for cancerous growths to disappear in his patients, he said.
Riddell suspects that his T cell therapy worked so well because the cancers he were treating were blood cancers. Instead of being bound up in solid tumors, the cancer cells are diffuse throughout the body, and also collect in certain sites where T cells also like to hang out: the bone marrow, blood, lymph nodes and spleen.
What's next
Still, Riddell hopes that his research can be re-purposed to begin attacking the more common cancers, like breast or colon cancer. These types present a special difficulty because solid tumors essentially create their own micro-environments that can turn off an active T cell, suppressing its immune system function.
"We’re going to have to learn to combine T cell therapy with things like check point inhibitors, which is another very effective form of immunotherapy for some patients with solid tumors, or to engineer T cells in ways that will allow them to function in that immunosuppressive microenvironment," Riddell said.
While his study is still in its earliest stages and has yet to be published in a peer-reviewed journal, he hopes that the technology can become available to the wider public within two to three years.
[color=red]"This is really another demonstration that [shows] the immune system can be used to treat cancer,”[/color] Riddell concluded. "I wouldn’t say yet that this will be applicable to all types of people with all cancers, but I think that the opportunity is there and the research directions now are really apparent."
CP, Interesting statement - on what would you base this assertion?
Danny, thanks for your post which I have excerpted in relevant part below:
Danny, you posted as follows:
Sunstar, thanks for your valuable ongoing commentary. A question relating to your recent post as excerpted in relevant part below:
Exwannabe, not so sure you're correct.
MH, We're on the same page - most definitely : )
MH - thanks once again for your response which I repost in relevant part below.
MH, thank you for your thoughtful response partially excerpted below in relevant part:
Hello Everyone, Yesterday I posted the following response to a post from Stone wherein he had asked RRdog for his estimation of the current value of Avid - however, RRdog had previously posted his estimation of Avid's probable value a week or so earlier in post number 251028. I then quoted from the post in relevant part the answer Stone was looking for. I then made the following statements and then asked a very important question to which NO ONE has responded.
Anyone care to take a shot at it ??