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Tradero,
Appreciate the effort and time developing this information.
Looking forward to your post on YTD performance next year.
This Dart deal and recent collaborations accomplish three fore planned outcomes.
1.Raise quick cash for immediate usage if needed.
2.Supplement data needed in BLA for SUNRISE.
3.Provide strong leverage for future deals once data released.
Which puts them in the drivers seat. IMO
Will you be reporting YTD performance next year?
nuke661 It gets old trying to explain to some folks. Good job.
What purpose do you serve here?
NM I see everyone has already rooted out all of these new trademarks
I like the word imminent best. notice the lack of sarcasm.GL
We are a day closer to "soon" happening too; for that matter, "imminent". Note the presence of sarcasm.
UGH the non-member rate for SITC is kind of high for registration to this event. Think I'll pass this go.
Nov4-8 2015: “(SITC) Society for Immunotherapy of Cancer 30th Annual Meeting
Agreed, thanks EOM
Yes dark cloud with silver lining. Excellent point made.
Agree with you to the tune of 25,000 more shares acquired this morning. The discussion of positive and material events like our MSK and AZN collaborations are ringing in my ears when I plunge more $ into this venture. Between all that's been discussed/divulged here and my own DD (pales in comparison) I think we should be talking about those signals and let the CSM thing die at this point. Frankly, I'm wondering if it wasn't a favor (by design or accident, don't know or care) as we may have dodged a bullet by NOT selling our precious molecule on the cheap to Abbvie. It may have cost us time but gained us knowledge and strength in negotiations. Remember, we own this thing..unencumbered, with bright lights on the horizon. The sun is rising. Soon. IMHO.
Do we have the comparative analysis figures for OS?
A topline analysis revealed that treatment with KEYTRUDA was associated with longer overall survival (OS) compared with docetaxel treatment
BKT these set backs were very detrimental for many to say the least for those owning shares during this time frame.Hopefully most are still in the stock because it is apparent this go around will be worth the wait and recovery can take place.
MH Thanks for lining it up some.
One does not need to be a google guru to ferret out the connections anymore. When the information starts to flow toward us all in plain view you know it's about to gain traction.
I believe this little bio company has the goods.
The puzzle picture is emerging. Last ten puzzle pieces are coming together fast. IMO
PS I like a good puzzle once in awhile.
It is inconceivable that the combination of Federal Regulators, BP (Abbvie on 2012, AZ in 2015), World Class Research Institutions (MSK, UTSW, etc.) can all be swindled into seeing things that are not there, approving compromised data into broader human trials, and gathering significant independent scientific momentum about the MOA/mechanism of the pathway and the molecule.
Just reviewed #29 in the link. Quite extensive. Thanks. EOM
I want to take a moment here on this message board to express my appreciation to cjgaddy and others for the compilation of the research material here for all potential investors to view. I know everyone here already appreciates it but I just wanted to re-emphasize it from a personal standpoint. I have directed many investors to this material to assist them in considering investing in PPHM.
I will just say some have established positions in the stock already pre approval based on the information provided.
The path to approval & License is seldom an easy one especially by a very small BIO. The late Dr. Thorpe and colleagues through years of work have discovered a unique player in the Immuno oncology space. Trials and tribulations aside we are on the threshold of approval with SUNRISE. IMO
This is a reality that should favor all of us.
Thanks for bringing us back down to reality I think.
Personally I am more optimistic about bavi.
BIO
We are approaching those ten final puzzle pieces I alluded to several post back. There will be an acceleration toward maximum intrinsic value for those that wait. IMO
Keep those puzzle pieces comming
I'll chime in. I do not know what the number will be upon approval
but it will be substantial enough to boost my retirement funds for sure. Certainly in the neighborhood of the twenties I would say.
Now if you ask me what the number will be about three to four years from now I would submit we are looking at a much higher PPS.
Have not given that much consideration on the enrollment completed PR. It would be a milestone. Not sure personally how much the PPS would move I'll leave that to others to comment on.
Yes I like that word imminent especially when it applies to approval.
With SUNRISE approval we will be.
Sunstar
Based on this declarative statement alone I believe Bavi is in the drivers seat for multitudes of collaborations once SUNRISE approved.
PD-1 and CTLA-4-targeting drugs have significantly improved patient survival in both melanoma and NSCLC, although their efficacy has been limited to a minority of subjects. Phosphatidylserine (PS)-targeting antibodies have demonstrated the ability to override tumor immune suppression and reactivate immune responses when combined with immunotherapies, chemotherapies, radiation, and targeted treatments. Recent translational data demonstrate the potential of PS-targeting antibodies to mediate immune activation and improved anti-tumor responses in low PD-L1 tumor samples.
Speaking for myself everything is predicated on SUNRISE. No additional designations for the other trials. IMO
Guys, what about a designation? Recall Peregrine got FTD at about the same time as the start of SUNRISE. Now there's a lot of new information, including from SUNRISE, about bavituximab's MOA. What are the chances of getting a designation, be it FTD or something else, for any of the new trials:
1. Paclitaxel/Docetaxel + B, HER2- MBC, to be started before YE2015
2. Durvalumab + B in solid tumors, in 2016
3. Durvalumab + B in sq+non-sq NSCLC, in 2016
4. HER2- early stage BC, under review
Got to love those rumors Heh?
This very interesting. I believe there have been a rumor two of Lily having an interest in pphm.
My take,
PPHM met stat sig endpoint for overall survival in Phase 11.
Patients were sicker on PPHM trial. EGOG higher
SNTA had no appreciable response on overall survival. Did not meet endpoints.
ECOG
SNTA 0-1
PPHM 0-2
Response rate
SNTA 8% vs 16%
PPHM* 8% vs 17%
PPHM** 11.3% vs 17%
PFS
SNTA 2.8 vs 4.2
PPHM* 3.0 vs 4.2
PPHM** 3.9 vs 4.2
OS
SNTA 7.4 vs NR
PPHM* 5.6 vs 12.1
PPHM** 7.3 vs 11.7
Actually I'll take half of those results joyfully. A little less piggy. HUH?
CP With this deal I would be counting money for a long time.
QUESTION 2: Given what PPHM has in its pipeline and IP portfolio with Bavituximab and BetaBodies how would you feel if GILD bought PPHM for 1 share GILD (approx. val 100$ today) + 100$ Cash per share (or 200 x 200Mil outstanding + options etc, say 200$ x 400Mil = 80Bil$ Total).
It would be nice if this sidebar discussion could be substantiated somehow.
Reason being my folks did not participate while there.
I was told (in a sidebar at the ASM meeting) that the company compared Bavi data against 67 other IO agents currently approved or in test...none had reported data results as strong or with a response as positive as those reported with Bavituximab. I am sure those comparisons are documented and being shared with many BP's and other interested companies.
FDA Approval & CA fallout
For sure full enrollment is a milestone for Sunrise. I will not predict the PPS when PR comes out that's for others to speculate on.
But if I have any chance for Loofmans corn licker will need a jump. Come on let's does this.
More exposure-starting to perk
From the Wall Street Journal
3 Biotech Stocks Getting Some Love: Peregrine Pharmaceuticals (NASDAQ:PPHM), BioDelivery Sciences International, Inc. (NASDAQ:BDSI), Vital Therapies Inc (NASDAQ:VTL)
By Beth Long -
October 19, 2015
From News Watch International
Company Shares of Peregrine Pharmaceuticals Inc. (NASDAQ:PPHM) Rally 2.8%
Oct 19, 2015
From Immuno-Oncology news
Peregrine Pharma and AstraZeneca Expand Partnership to Evaluate Bavituximab-Durvalumab Teatment In Non-Small Cell Lung Cancer
October 19th, 2015 Anna Tan, RN
Plus many more mentions today from other sources
It ain't over until the fat lady sings. Today's date 10/18
Still time for others to claim Loofman's corn licker.
I'm guessing after I win lufmans stock price picking contest (out of 58 entries) you'll still claim to be "right" about this? LOL
What was your 12-31-15 supposedly "sobered up" price again, I forgot.
I think different design in terms of ECOG 0 & 1 (healthier patients) and ARMS.
Patients will be randomized into 1 of 2 treatment arms
2. PPHM salvages the data sufficiently to have the FDA approve a phase III of the same design as the phase II
Is this Amylin purchase by BMY & AZ related to this process?
FDA rejects AstraZeneca's diabetes combo and demands more data
October 16, 2015 | By Damian Garde
The FDA wants to see more clinical trial data on AstraZeneca's ($AZN) new combination diabetes treatment, the company said, likely delaying a potential launch by more than a year.
AstraZeneca's combo is a fixed-dose mix of saxagliptin, approved as Onglyza, and dapagliflozin, sold as Farxiga, designed to treat Type 2 diabetes. In its rejection letter, the FDA asked for additional data on the cocktail, a request that "may require information from new studies," AstraZeneca said. The company has pegged $3 billion in peak annual sales to the combination, a forecast now imperiled by regulatory delay.
EX-US Partnering
Bayer in liver indication still out there?
Partnering
Broad Networking for long-term success
To be able to develop innovative products, a company needs an appropriate environment – in Germany, in Europe and worldwide – and strong partners.
With a global network of external scientific and industrial development partners, we strengthen our own research infrastructure and, therefore, assure the long-term success of our product pipeline.
To supplement our internal efforts, we collaborate with several companies in different stages of the typical pharmaceutical research cycle. Our more significant collaborations are described (in alphabetical order) in the table below.
Partner
Objective
Affymetrix Understanding the disease mechanism and identifying new targets
ARTEMIS Pharmaceuticals GmbH In vivo validation of targets
Astra Zeneca Co-development of the selective estrogen receptor downregulator (SERD) for the treatment of hormonal dependent breast cancer
Avid Radiopharmaceuticals Radiopharmaceuticals compounds
Bausch&Lomb
SEGRA ophthalmology
Celera Genomic Cathepsin S inhibitor drug development program
ChemDiv Synthesis of compounds
ComGenex Synthesis of compounds
Genedata Expressionist software
Genzyme Corporation Campath in chronic lymphocytic leukemia and multiple sclerosis
Inpharmatica Kinase SARfari in Silico Drug Discovery
Johnson & Johnson Development of Rivaroxaban
Monash University New targets for gender health
MorphoSys AG Antibody diagnostics and therapeutics for cancer and other life threatening diseases
Nektar Therapeutics Targeted inhaled antibiotic therapy for pulmonary infections
Neurosciences Victoria Ltd. Treatment of neurodegenerative disorders
Novartis Pharma Research and development of inhibitors of angiogenesis
Nuvelo Development of alfimeprase
Onyx Co-development of Nexavar
Peregrine Pharmaceuticals, Inc. Selective cancer diagnostics (vascular targeting agents)
Philogen S.p.A. Development of immunoconjugates for cancer therapy and diagnosis
Proteros X-ray structure analysis
Regeneron Pharmaceuticals Development of the VEGF Trap for the treatment of eye diseases
Seattle Genetics Increasing the pool of potential drug candidates by biomolecules
Sonus Pharmaceuticals TOCOSOL Paclitaxel
Stanford University/Gambhir New PET tracers
Warner Chilcott SEGRA for dermatology
The simplistic puzzle analogy: Assume 100 pieces
The puzzle pieces are coming together and a picture is emerging.
But until the final piece is fitted in "labeled approval" it is not a completed puzzle.
However, like all puzzles it takes time to arrange different sections of the puzzle to piece them together. When they connect and form up the picture the process simplifies and speeds up.
When the puzzle is almost completed and you have 10 pieces left and 10 connections to place it becomes very clear. The final pieces rapidly come into place.
Question: Stay on the sidelines and wait for those final 10 pieces get placed or get in while the puzzle is not fully formed.
For those on the fence:
Pay more later and be safer or pay less now and speculate some.
ACK-I was thinking of BIO and his puzzle pieces.
edited
Motley said this morning we have a lot of time left before the stock answers the bell so why buy cheap when you can stay on the sideline and wait for approval and a higher price.
Makes sense for the conservative investor.
But most of us are basing our decisions on what we expect and know.
IMO