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Interesting end of day. It looks like you may be onto something, Sir.
If the court finds that CSM's potentially illegal conduct is not subject to any "limit of liability" clause in the service contract, it looks like damages could reach 9 figures. All imo.
No dime from CSM? How about lots of dimes from its insurance companies?
Available, yes. But they are both in large PDFs and as far as I know there is no way to post them directly to the board, so I used OCR to extract some portions to cut and paste into a post.
Is CSM's story and motion also available? can it be posted?
I currently am somewhere off coast of France in Mediterranean at the moment with an IPad.
Agree that the damages appear to greatly exceed $32MM, which is why CSM is trying to limit them before the case gets to trial. All imo.
Kind of runs contrary to the narrative that there is no scientific promise and management is doing nothing more than running the ATM and other financing vehicles simply to preserve their own salaries while producing nothing of value to shareholders. Guessing that at least one particular "financial media" sock puppet will have his panties in a bunch now...
"With the anticipated success of this trial, Peregrine expected to promptly partner with or be acquired by a global pharmaceutical company and move into a Phase III trial for NSCLC patients and commence other trials. Bavituximab could be potentially developed for or as a cancer vaccine. Bavituximab also has indications of benefit for other diseases such as Hepatitis C and HTV."
1. PPHM was close to a partnership or acquisition.
2. Bavi could be developed into a vaccine(or combined with a vaccine). Elsewhere it is stated that Bavi might be used in the PREVENTION of cancer!
3. The viral indications still have potential.
Filed on 6/23
Declaration of Joseph Shan. See caveats in original post about the quality of the OCR scan from the original pdf.
Starting at paragraph 19, one can see just how close the company was to MASSIVE success before the CSM debacle, and just how much damage, delay, and additional costs were caused. Say what you will about management, but they did engineer a spectacular recovery from this mess, and the endgame appears to remain clearly in focus. All imo, of course.
FROM: DECLARATION OF JOSEPH S. SHAN, M.P.H. IN OPPOSITION TO DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT
I, Joseph S. Shan, M.P.H,, declare:
1. I am competent to and would testify to the following if called upon to do so as a witness.
Background
2. I received my Bachelor of Science degree in Physiological Sciences from the University of California, Los Angeles and my Master's Degree in Public Health ("M.P.H.") from the George Washington University in Washington, D.C. I am a member of the American Society of Clinical Oncology, the Association of Clinical Research Professionals and the Regulatory Affairs Professionals Society.
3. I have served as Vice President, Clinical & Regulatory Affairs of Plaintiff Peregrine Pharmaceuticals, Inc. ("Peregrine") since March 2009. I also served as its head of Clinical and Regulatory Affairs from January 2003 to March 2009. In my current capacity, I have been responsible for the design and execution of our clinical trials and overseeing regulatory submissions.
4. Prior to joining Peregrine, I held positions of increasing responsibility in clinical and regulatory affairs at Edwards Lifesciences (formerly Baxter Healthcare Corporation), an international pharmaceutical company, and at Sulzer Medical, a healthcare division of another international organization.
5. I executed on Peregrine's behalf the Master Services Agreement ("MSA") with Defendant Clinical Supplies Management, Inc ("CSM") dated March 16, 2010 that is at issue in this case. I was one of the members of the Peregrine management team primarily responsible for carrying out Peregrine's role in the Phase II bavituximab clinical trial at issue in this case.
Overview of the Phase IINSCLC Double-Blind Trial
6. Peregrine's lead product candidate, bavituximab, is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, that "flips" and becomes exposed on the outside of cells that line tumor blood vessels, causing the tumor to evade immune detection. Bavituximab targets PS and blocks this immunosuppressive signal, resulting in the maturation of dendritic cells and cancer-fighting (Ml) macrophages leading to the development of cytotoxic T-cells that fight solid tumors. Bavituximab is the lead drug candidate from Peregrine's PS-targeting technology platform.
7. The subject clinical trial involving CSM was a randomized, double- blind, placebo-controlled Phase lib trial in which Bavituximab doses were combined with either docetaxel (chemotherapy) or placebo in patients who had been previously treated unsuccessfully for locally advanced or metastatic non-squamous non-small cell lung cancer ("NSCLC"). The goal was to demonstrate increased anti¬tumor activity (shrinking of tumors, delay of disease progression or extension of life) for the non-placebo patients through the addition of bavituximab, as had been experienced in prior similar clinical trials.
8. The study was designed by Peregrine representatives, including me, as a double-blind study, meaning the various patients, treating physicians, the Contract Research Organizations ("CROs") hired to collect and verify trial data, and Peregrine itself would not know the dosage assignments given to the patients in order to avoid any potential bias in patient outcome. I designed the study to contain three treatment arms. One group of patients, the control or "A" arm, would receive docetaxel plus placebo treatments to serve as a baseline to compare the responses of the other two arms. The second or "B" arm would receive 1 mg/kg doses of bavituximab plus docetaxel. The third or "C" arm patients would receive 3 mg/kg doses of bavituximab plus docetaxel. The trial evaluated 121 patients randomized into the three treatment arms in 40 sites around the world. Patient enrollment was completed in October 2011.
9. This trial was Peregrine's most important clinical trial to date. The trial was designed as a registration study, such that if the trial results showed a statistical significance in median overall survival, Peregrine would have had the ability to seek FDA approval to immediately proceed into a Phase III trial or even potentially seek accelerated approval based on the results. Bavituximab had already demonstrated great promise in treatment of other forms of cancer in earlier clinical studies. The
PARTIAL SUMMARY JUDGMENT
success of the Phase lib NSCLC study also likely would have propelled Peregrine into a late-stage development company about to embark on commercialization.
10. Peregrine utilized an experienced clinical trial consultant to coordinate experienced vendors to perform the work needed (which Peregrine could not directly perform or even oversee due to the double-blind nature of the trial). Eight main vendors and other vendors, were assembled to perform the trial. Perceptive Informatics ("Perceptive") was contracted to provide randomization services for assignment of patients to treatment groups through a detailed proprietary product called "Clinphone Compact" ("Clinphone") developed by Perceptive. The project specifications were set forth in great detail with the Clinphone Project Requirements Specification document (PPHM 0902) ("Project Requirements Specification") which allocated responsibilities to all contractors and restated them in flow charts. CSM was designated to perform cGMP ("current good manufacturing practices") labeling, packaging, and distribution/reconciliation of the clinical product. Other vendors were designated to perform data management and statistical analysis, to manufacture lab kits, perform immunology testing and monitor blood work.
The CSM Contract
11. The CSM Master Services Agreement ("MSA") contains a number of provisions pertinent to its services in the trial including the following:
3. SERVICES
A. CSM hereby agrees to provide CLIENT the Services described in each Work Order. In performing the Services, CSM will comply with any applicable study protocol which will be identified by name and number therein, this Agreement, the applicable Work Order, the written instructions of CLIENT, relevant professional standards and all applicable laws, rules and regulations including, but not limited to, the Federal Food Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and with any other applicable laws including, without limitation, the Hazardous Materials Transportation Act.
B. CSM's tasks specified in the Work Order, including any Change Order(s), will constitute the sole tasks assigned by CLIENT to CSM pursuant to 21 CFR 312.52.
15. CONFORMANCE WITH LAW AND ACCEPTED PRACTICE
CSM will perform its obligations under this Agreement in conformance with generally accepted standards of good clinical practice ana good manufacturing practice, with the terms of the Work Orders, and with all applicable local,
state and federal laws and regulations governing the performance of clinical investigations...
Attend Peregrine... project meetings to communicate current activities and planning for clinical supply needs
Based on the packaging and labeling instructions, procure components and labels required for packaging and labeling.
Obtain approved randomization schedule from Peregrine...or designee
Print required labels from approved label proof for all supplies to be packaged and labeled
Conduct packaging and labeling in accordance with Good Manufacturing Practices (cGMP)
Prepare a Distribution Processing Protocol and Clinical Supplies Shipment Request and Confirmation (CSSRC)
form for distributing drug supplies.
Prepare materials for presentation at Kick Off Meeting
Attend Kick Off Meeting and participate in training sessions
Present the role of CSM in the clinical supplies process for the study
The Kick-Off Meeting
12. On February 25-26, 2010, Peregrine hosted a kick-off meeting for the trial in Doheny Beach for a day and a half to discuss the roles of each vendor, including the eight vendors referred to above, and to make sure their efforts were properly coordinated. I attended this kick-off meeting. Importantly, although Peregrine was the "client" and the "Sponsor," it's role was necessarily limited in light of the double-blind aspect of the trial, and so the kick-off meeting was intended to hand off the coordinated vendor efforts based on Perceptive's Project Requirements Specification document.
13. During the kick-off meeting, those in attendance included Jeanette Bleecker from CSM. It was determined through discussion among the group, that CSM would receive shipments of placebo, 1 mg/kg Bavituximab and 3 mg/kg Bavituximab in separate lots from Avid Bioservices totaling approximately 8,000 vials. It was supposed to label the 8,000 vials as instructed by Perceptive using a form of label agreed to with Peregrine. CSM shared marketing slide charts at the kick-off meeting confirming that it had the capability to perform these tasks. CSM therefore was responsible for supply chain activity, ensuring proper labeling and distribution to sites, and product vial reconciliation to inventory.
14. As explained in the kick off meeting by Peter Jalen of Perceptive, pursuant to the Project Requirements Specification, his company would apply the Clinphone patient randomization program and direct CSM to distribute placebo,
1 mg/kg or 3 mg/kg doses accordingly to the trial sites, to thereafter be processed by pharmacists and distributed to physicians to administer to the patients in the study. Thereafter, CSM would keep track of the administration of the doses and which patients fell into which treatment arm until the study was unblinded. Due to the blinded nature of the study, Peregrine, as well as many of the other vendors participating in the trial, was dependent on CSM to strictly follow the protocol developed by Perceptive set forth in the Project Requirements Specification document.
15. Interim data from the trial in September 2012, showed a statistically significant improvement in overall survival and a doubling of the median overall survival in lung cancer patients treated in the bavituximab-containing arms compared to those patients treated in the placebo arm. These were very positive
developments for Peregrine because bavituximab was demonstrating a significant extension of life for very ill patients.
16. After the announcement, as Peregrine planned for an end-of Phase II meeting with the FDA to discuss proceeding into a Phase III study or potentially seeking marketing authorization with the phase II results, I was informed of the pharmacokinetic ("PK") results from the testing laboratory which evaluated blood supplies from a subset of 18 patients who participated in the PK "substudy" of the trial. Those 18 patients were evaluated for potential drug-drug interaction between bavituximab and docetaxel. With that information, and a drug coding memo from CSM in September 2012, there were indications that the A and B treatment assignments may have been switched during the trial by a vendor, Clinical Supplies Management ("CSM"). Based on this, Peregrine initiated a "for cause" audit of CSM's performance under the study.
Financial Impacts of CSM's Errors
17. As explained below, the ensuing damage to Peregrine is many times the amount paid to CSM for its services, and CSM's errors could not have been more inopportune. With the anticipated success of this trial, Peregrine expected to promptly partner with or be acquired by a global pharmaceutical company and move into a Phase III trial for NSCLC patients and commence other trials. Bavituximab could be potentially developed for or as a cancer vaccine. Bavituximab also has indications of benefit for other diseases such as Hepatitis C and HTV.
18. The Phase II study at issue cost in excess of $12,000,000 in direct third party costs alone, not to mention the significant internal man-hours and associated costs. The results of the 3 mg/kg arm of the study have value in that Peregrine was able to combine the "A" and "B" arm results and compare them to the "C" arm results. (The "A" and "B" groups collectively can be assumed to have received some bavituximab at the 1 mg/kg level, and Peregrine can compare their survival data to that of the 3 mg/kg patients.)
19. Had the study, which was initially reported as demonstrating statistically meaningful overall survival benefits, been confirmed, Peregrine could potentially have sought early approval and sales of the product. This likely would have shaved at least 3 to 4 years from the program and resulted in early commercial sales. While a confirmatory Phase III trial would still need to be done, the FDA's practices and guidances indicate that it would have required only 300-400 patients in our ensuing Phase HI study based on the hazard ratio determined in the Phase II study.
20. However, once the regulatory violations were confirmed (as discussed in the Masten Declaration), the value of the Phase II study as a registration study was so severely compromised that any option for an early FDA approval was eliminated. Thus, Peregrine was forced to conduct a larger than anticipated Phase III trial of approximately 600 patients based on an increased hazard ratio estimate.
21. Stated differently, the Hazard Ratio ("HR") is used to determine the overall reduction in risk (1 minus the HR = % reduction) in a time-to-event endpoint such as overall survival. The Phase II results prior to the discovery of the CSM labeling issue was estimated to be ~0.5 which means those receiving bavituximab and chemotherapy had almost a 50% reduction in risk of death. This result was statistically significant (p < 0.05) and based on those results, Peregrine was planning to conduct a Phase m trial to target a 0.6 HR which would have required only approximately 300-400 patients in the ensuing Phase III study. Due to the errors by CSM, the data had to be reanalyzed by pooling the two study arms that CSM swapped and the HR increased to 0.662. Thus, Peregrine had to re-power the present Phase III study for a higher HR, requiring that the present Phase III study enroll -600 patients instead of 300-400 patients,
22. The estimated clinical trial external cost for our present Phase III trial per patient is $100,000, which is consistent with the per patient cost of the damaged Phase II trial. Due to CSM's errors described in the accompanying Masten Declaration, requiring an additional 200 patients or more in the present trial as explained above, the extra costs of the current trial will total approximately $20 million.
23. Additionally, Peregrine will suffer at least a six month loss in time to market. These events will also hamper bavituximab's procession into the broader cancer indications and new trials related to viral infections discussed above.
Declaration of Jeffery Masten attached to Court filing. Same caveats on the OCR scan regarding accuracy and glitches from my original post. Research the original Court filing for complete accuracy.
FROM: DECLARATION OF JEFFREY MASTEN IN OPPOSITION TO DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT
I. Jeffrey Masten, declare:
1. I am competent to and would testify to the following if called upon to do so as a witness.
2, My professional career has primarily been devoted to quality assurance in the pharmaceutical industry. My career began in quality assurance with EH Lilly & Company where I worked from April 1980 to November 1997. After that, I worked for Avcntis Behring until March 2002, where I held the title of Director,
Quality Assurance upon my departure. I next worked for Genentech from April 2002 until April 2010, where I held the position of Sr. Director, Quality. While working, I studied for and received my M.B.A. from the University of Notre Dame, Mendoza College of Business in 2002. After my departure from Genentech, I joined Peregrine Pharmaceuticals, lac. ("Peregrine"), where I worked from May 2011 through February 2014, holding the title of Vice-President, Quality.
3. When I joined Peregrine, the Phase II bavituximab trial (the "trial") at issue in this case was already underway. I was assigned the quality assurance responsibilities for the trial when I joined Peregrine. The trial is discussed in the accompanying Declaration of Joseph Shan.
The Audit
4. Because of concerns about how the trial may have been administered, I and others at my direction, on behalf of Peregrine, audited the performance of all of the contractors in the study. The audit team ultimately concluded that CSM was the sole cause for errors we observed in the trial. Indeed, I was advised by CSM management that there was an intentional action taken by CSM to switch the vial labeling for the "A" and "B" treatment arms. All other parties we spoke with agreed that the Perceptive Clinphone specifications were supposed to be followed by all vendors, yet upon review and discussion with all the other vendors, none were aware that CSM took this action to switch the labeling. CSM informed me that they switched the labeling to protect the blinded nature of the trial design.
5. As part of the audit, I flew to F argo, North Dakota to get to the bottom of the problem and visited CSM on September 19,2012. I initially met with Angela Buchanan, the Director of QA at CSM, on September 20,20i2. Buchanan admitted to me that Project Manager, Jeanette Bleecker ("Bleecker"), had switched the treatment code assignments for the control (placebo) and 1 mg/kg arms in violation of the Project Requirements Specification document and CSM Standard Operating Procedures ("SOP") and apparently did not mfoim any other management employee in the company. Initially, Buchanan said to me that she had no idea why this was done. Buchanan indicated that she was still a friend of Bleecker's and volunteered to me that Bloccker had taken a one week bereavement leave in late February 2011, and then terminated her employment on August 5,2011. She also explained that later, Gerald Finken, CEO, took over Bleecker's role while she took her leave, and apparently continued to approve the same switching of labeling for the two treatment groups without QA knowledge.
6. Under my direction, of the 8,000 vials manufactured for the study, approximately 7500 vials were retrieved from sites around the world, and of those, 99% contained enough volume to determine their contents. Our audit confirmed that all C group patients were correctly treated with 3 mg/kg bavituximab doses. However, we found serious evidence of vial mislabeling between the placebo and 1 mg/kg groups. In light of the labeling process that CSM should have employed in accordance with cGMP regulations and its own SOPs, it is inconceivable that the original labels could have been misapplied. And so the inference is that some labels were swapped. Additionally, some of the type of labels used by CSM allowed them to be removed without leaving a trace of residue to evidence such potential tampering; whereas proper labeling under cGMP regulations would not have permitted this. The industry standard, within the applicable FDA regulations (including those noted in 21 CFR Parts 211.125 and 211.130), is to use labels that' cannot be removed, thereby preventing any possibility of label tampering. The number of mislabeled vials is small but, by extrapolation the mislabeling problem potentially implicated mathematically up to 25% of the total vials labeled for placebo and up to 25% of the total vials labeled for 1 mg/kg treatments.
7. In carrying out its tasks, CSM was obligated and contracted as a Contract Research Organization ("CRO") to comply with industry standard good clinical practices ("cGCP") established by the 'international Conference on Harmonization ("ICH") Guidelines, and to comply with various Food and Drug Administration ("FDA") mandated good manufaeiiiring practices (ncGMP") regulations including, without limitation, those set forth in 21 CFR Parts 210 (Current Good Manufacturing Practice in Manufacturing. Processing, Packaging, or Holding of Drugs, General), and 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals),
8. Under proper cGMP labeling, there should have been no possibility any product mislabeling could occur at the inception of the study, or anytime labeling of investigational product was required. Further, the only judgment Ms. Bleecker had to exercise was to anticipate adequate amounts of doses to be shipped to the treatment sites so that inventory was not wasted and vials were always available to the patients when needed. However, when the approximately 7500 vials were recovered, some appeared to have their label removed and a few had no label at ail.
9, The audit also revealed that Bleecker took other bizarre actions that she did not apparently do for other similar client trials. She did not inform any other vendor and did not disclose that she had made any deviation to the Perceptive Clinphone protocol. Significantly, she didnt advise her Director of QA, Angela Buchanan, that she had taken this step. Had Ms. Bleecker been authorized to make such a change, she was required to notify certain of the vendors; most notably, Perceptive, Upon such a change, Perceptive would have been required to redo its validated Clinphone and the Project Requirements Specification, which would have taken a significant amount of time and money to revise, revalidate and obtain approval prior to the trial commencing. She and CSM did not do that. And so these unilateral steps by CSM are not explainable or defendable from an industry practice and regulatory standpoint. Additionally, she maintained her own tracking of product inventory to and from the clinical trial sites, as some sites returned their unused product vials as well as some used product vials. We were informed by Ms, Buchanan (QA) thai this practice was not according to CSM SOP and not performed for any other client's trial.
10. Based on our audit, CSM violated 21 CFRPart 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, ocr Holding of Drugs, General) and 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals). CSM violated 21 CFR 211.125 (labeling issuance) by using labels that could be removed and reapplied, and by switching the label assignments to the treatment groups. Based on our audit, CSM also violated 21 CFR 211.130 (packaging and labeling operations) by not labeling the vials in a manner that potentially allowed them to be accurately tracked later. CSM also violated 21 CFR 211.142 (warehousing procedures) by not ensuring the vials were stored in a manner ensuring the identity of the contents, strength, quality and purity could be determined later. Based on our audit, CSM also violated 21 CFR 211.150 (distribution procedures) based on the various examples in which supposed placebo patients (according to CSM based on the swap of the "A" and T,B" arms), actually showed indications they did receive some levels of bavituximab.
11, Additionally these violations also transgress corresponding industry standard practices set forth by the ICH.
Excerpts from Court Filing in CSM Case. Caveat that this is an OCR scan of the PDF Court filing. It may not be 100% faithful transcription and may have some OCR glitches. This gives a good picture of the extent of setbacks, damage, and delay allegedly caused by CSM. Because of the sheer length of the filing, I left out the section with the legal arguments against exculpatory caps. Anyone with further interest and desiring a fully accurate transcription should research the actual filings.
From: PEREGRINE'S OPPOSITION TO DEFENDANT CLINICAL SUPPLIES MANAGEMENT, INC.'S MOTION FOR PARTIAL SUMMARY JUDGMENT
A. INTRODUCTION
Clinical Supplies Management, Inc.'s ("CSM") Motion completely misses its mark. It seeks to limit its liability to Peregrine Pharmaceuticals, Inc. ("Peregrine") to the amounts it was paid for its services through exculpatory clauses that run afoul of California Code of Civil Procedure § 1668 ("section 1688") and rail against established California public policy. CSM does not even cite section 1688 in its papers and erects strawman arguments that fail to reach the applicable legal analysis. The Court should deny the Motion.
B. FACTUAL BACKGROUND
1. The Parties
Peregrine is a clinical-stage biopharmaceutical company developing first-in- class monoclonal antibodies focused on the treatment and diagnosis of cancer. Peregrine is a publicly-traded company based in Tustin, California. CSM provides clinical trial services to pharmaceutical companies. It is located in Fargo, North Dakota.
2. Overview Of The Phase IINSCLC Double-Blind Trial
A discussion about the trial and CSM's critical role (explained in the accompanying Declaration of Joseph Shan ("Shan Decl.")) may help the Court consider the legal issues presented by CSM's Motion.
The trial was a randomized, double-blind, placebo-controlled Phase lib trial in which bavituximab doses were combined with either docetaxel (chemotherapy) or placebo in patients who had previously treated unsuccessfully for locally advanced or metastatic non-squamous non-small cell lung cancer ("NSCLC"). The goal was to demonstrate increased anti-tumor activity for the non-placebo patients through the addition of bavituximab as had been experienced in prior similar clinical trials.
These late stage lung cancer patients would hopefully display tumor shrinkage and enjoy extension of life through the treatments. (Shan Decl. 6-7.)
The study was designed by Peregrine representatives as a double-blind study,
meaning the various patients, treating physicians, the organizations hired to collect and verify trial data and Peregrine itself would not know the dosage assignments given to the patients in order to avoid any potential bias in patient outcome. Peregrine designed the study to contain three treatment arms. One group of patients, the control or "A" arm, was supposed to receive docetaxel plus placebo treatments to serve as a baseline to compare the responses of the other two arms. The second or "B" arm patients were supposed to receive 1 mg/kg doses of bavituximab plus docetaxel. The third or "C" arm patients were supposed to receive 3 mg/kg doses of bavituximab plus docetaxel. Candidates for the study were hard to identify. The trial ultimately evaluated 121 late-stage NSCLC patients randomized into the three treatment arms in 40 sites around the world. Patient enrollment was completed in October 2011.
This trial was Peregrine's most important clinical trial to date. The trial was designed as a registration study, such that if the results demonstrated statistical significance in median overall survival, Peregrine would seek FDA approval based on the results of the trial. Bavituximab had already demonstrated great promise in treatment of other forms of cancer in earlier clinical studies and the success of the NSCLC study would have propelled Peregrine into a late-stage development company about to embark on commercialization. This trial was also expected to enable Peregrine to partner with a large global pharmaceutical company to fund a Phase III trial to leverage the global pharmaceutical company's commercial sales and marketing expertise and fund future advanced clinical trials in other indications. (Shan Decl. If 9.)
Peregrine had not previously performed a double-blind trial, and so it utilized an experienced clinical trial consultant to coordinate experienced vendors to perform the work needed (which Peregrine could not perform due to the double-blind nature of the trial). Based on the consultant's recommendations and experience, eight main vendors, along with other vendors, were assembled to perform the trial. Perceptive
Informatics ("Perceptive") provided randomization services for assignment of patients to treatment groups through a detailed proprietary protocol called "Clinphone Compact" ("Clinphone"), which set forth the project specifications and allocated responsibilities to all vendors and restated them in flow charts. (Shan Decl. 110.)
The delegation of CSM's responsibilities in the trial was also clearly specified in a group meeting of vendors before the trial began. On February 25-26, 2010, Peregrine hosted a kick-off meeting for the trial to discuss the roles of each of the eight vendors so their efforts were properly coordinated among them. Importantly, although Peregrine was the "Sponsor," its role was necessarily limited in light of the double-blind aspect of the trial, and so the kick-off meeting was intended to hand off the coordinated vendor efforts among the vendors based on Perceptive's documents. (Shan Decl. f 12.)
CSM was specified to be responsible for supply chain activity, ensuring proper labeling and distribution to sites, and product vial reconciliation to inventory. It would receive shipments of placebo, 1 mg/kg bavituximab and 3 mg/kg bavituximab in separate lots ultimately totaling approximately 8,000 vials. It was supposed to label the 8,000 vials as instructed by Perceptive using a form of label agreed to with Peregrine. In accordance with cGMP labeling, there was no possibility any product mislabeling could occur at the inception of the study. (Shan Decl. If 13.) The only judgment Jeanette Bleecker, the CSM Project Manager for this clinical trial ("Bleecker"), had to use was to anticipate adequate amounts of doses to be shipped to the treatment sites so that inventory was not wasted and vials were always available to the patients when needed. (Jeffrey Masten Decl. f 8 ("Masten Decl.")) CSM shared marketing slide charts at the kick-off meeting confirming that it had the capability to perform these tasks. (Shan Decl. If 13.)
As explained in the kick off meeting by Peter Jalen of Perceptive, pursuant to the Project Requirements Specification, his company would apply the Clinphone
patient randomization program and direct CSM to distribute placebo, 1 mg/kg or 3 mg/kg doses accordingly to the trial sites, to thereafter be processed by pharmacists and distributed to physicians to administer to the patients in the study. Thereafter, CSM would keep track of the administration of the doses and which patients fell into which treatment arm until the study was unblinded. Due to the blinded nature of the study, Peregrine, as well as many of the other vendors participating in the trial, was dependent on CSM to strictly follow the protocol developed by Perceptive. (Shan Decl. ^14.)
3. MSA Provisions
There can be no doubt from an examination of the Master Services Agreement between CSM and Peregrine ("MSA") that CSM was expected to comply with industry regulations in providing its designated services. These MSA provisions include:
3. SERVICES
A. CSM hereby agrees to provide CLIENT the Services described in each Work Order. In performing the Services, CSM will comply with any applicable study protocol which will be identified by name and number therein, this Agreement, the applicable Work Order, the written instructions of CLIENT, relevant professional standards and all applicable laws, rules and regulations including., but not limited to. the Federal Food. Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and with any other applicable laws including, without limitation, the Hazardous Materials Transportation Act.
B. CSM's tasks specified in the Work Order, including any Change Order(s), will constitute the sole tasks assigned by CLIENT to CSM pursuant to 21 CFR 312.52.
15. CONFORMANCE WITH LAW AND ACCEPTED PRACTICE
CSM will perform its obligations under this Agreement in conformance with generally accepted standards of good clinical practice and, good manufacturing practice, with the terms of the Work Orders, and with all applicable local, state and federal laws and reflations governing the performance of clinical investigations... (emphasis added.) (Shan Decl. 111.)
As set forth in those provisions and by established industry practices, in carrying out these tasks, CSM was obligated as a Contract Research Organization
("CRO") to comply with good clinical practices established by the International Conference on Harmonization ("ICH") Guidelines and to comply with various Food and Drug Administration ("FDA") regulations setting forth good manufacturing practices ("cGMP"). These included the good manufacturing practices established by and set forth in 21 CFR Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs, General), and Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals). These obligations also included the specific requirements of many subparts of 211, including (i) 211.125 labeling issuance, subparts (a-f); (ii) 211.130 Packaging and labeling operations, subparts (a-e); (iii) 211.142 Warehousing procedures, subparts (a-b); and (iv) 211.150 Distribution procedures, subparts (a-b). As explained in the accompanying Masten Declaration, CSM did not comply with these regulations in profound ways. (Masten Decl. 6-12.) CSM's actions preclude it from relying on the exculpatory clauses to limit its liability as attempted by this Motion.
The decision to unblind such a study is made by an independent scientific body, the Independent Data Monitoring Committee. Data from the trial announced in May 2012 showed a doubling of overall response rates and an improvement in progression-free survival in patients treated in the bavituximab-containing arms when compared to those treated with placebo. Interim data publicly announced on September 7, 2012, showed a statistically significant improvement in overall survival and a doubling of the median overall survival in patients treated in the bavituximab-containing arms compared to those patients treated in the placebo arm. (Shan Decl. f 15.) These were very positive developments for very ill patients, and were quite exciting for Peregrine.
4. The Audit and CSM's Errors
In September 2012, Peregrine received pharmakinetic ("pk") results from the testing laboratory which evaluated blood supplies from a subset of 18 patients who participated in the pk "substudy." Those 18 patients were evaluated for potential
drug-drug interaction between bavituximab and docetaxel. With that information, and a drug coding memo from CSM, there were indications that the "A" and "B" treatment assignments may have been switched, but CSM provided no explanation or elaboration. Based on this, Peregrine initiated a "for cause" audit of CSM's performance under the study. (Shan Decl. If 16.)
Peregrine Vice President QA, Jeff Masten, flew to North Dakota to get to the bottom of the problem and visited CSM on September 20, 2012. Masten initially met with Angela Buchanan, the Director of QA at CSM. Buchanan admitted to Masten that Bleecker had switched the control and 1 mg/kg arms in violation of the Project Requirements Specification document and CSM Standard Operating Procedures ("SOP"), didn't tell anyone, and Buchanan had no idea why. These were clear violations of 21 CFR Part 211.150 and 312.52. Later, when Gerald Finken took over Bleecker's role, Buchanan admitted no one went back to check the Perceptive Project Requirements Specification document to make sure it was being followed by CSM. Buchanan indicated that she was still a friend of Bleecker's and volunteered to Masten that Bleecker went on leave in February 2011 and terminated her employment with CSM in August 2011. (Masten Decl. If 5.)
Bleecker's decision to secretly swap the "A" and "B" arms of the study so that patients that should have received 1 mg/kg treatments received the placebo treatments, and vice-versa, was inexplicable. Bleecker did not inform any other vendor that she had made any sort of change at all. She did not even advise her Director of QA, Angela Buchanan, that she had done so. And so her activities violated many ICH rules and FDA regulations, including those contained in 21 CFR Parts 211.125, 211.130, 211.142 and 211.150. (Masten Decl. flf 5, 11, 12.)
Whatever her motivation, if Bleecker been authorized to make such a change, she would have needed to notify certain of the vendors, including Perceptive. Upon such a change, Perceptive would have needed to redo its validated Clinphone and the Project Requirements Specification, which would have taken a significant
amount of time and money to revise, revalidate and obtain approval prior to the trial commencing. (Masten Decl. Tf 9.) Instead, she proceeded unilaterally after expressly confirming, falsely, that she was following the Clinphone protocol.
In connection with the audit, approximately 7500 vials were retrieved from sites around the world, and of those, 99% contained enough volume to determine their contents. The audit confirmed that all C group patients were correctly treated with 3 mg/kg bavituximab doses. However, there was serious evidence of vial mislabeling between the placebo and 1 mg/kg groups. In light of the labeling process that CSM should have employed in accordance with cGMP regulations and CSM SOPs, it is inconceivable that the original labels could have been misapplied. And so the inference is that some labels were swapped. (Masten Decl. 16.) Additionally, the type of labels used by CSM allowed them to be removed and swapped without leaving a trace of residue to evidence such tampering; whereas proper labeling under cGMP regulations would not have permitted this. (Masten Decl. Tf 6.) The industry standard, within the applicable FDA regulations (including those noted above, such as 211.125 and 211.130), is to use labels that cannot be removed thereby preventing the issues which CSM caused. The number of mislabeled vials is small but the mislabeling problem implicates mathematically up to 25% of the total vials labeled for placebo doses and up to 25% of the total vials labeled for 1 mg/kg treatments. (Masten Decl. f 6.)
These discoveries indicated that CSM didn't even follow the labeling protocol by using cGMP labels, as is the industry standard, on a majority of the vials CSM labeled. (Masten Decl. If 8.) Further, the problems turned out to be even more serious as there was no apparent rhyme or reason to the distribution of placebo and 1 mg/kg treatments by CSM, even assuming Bleecker had just swapped the "A" and "B" treatment arms. Again, these were clear violations of 21 CFR Parts 210 and 211 including, but not limited to, 211.125,211.130, 211.142 and 211.150. (Masten Decl. Tflf 11-12.)
5. Fallout And Damages
The Phase II study at issue cost Peregrine well in excess of $12,000,000 in direct third party costs alone, not to mention the significant internal man-hours and associated costs. Due to CSM's errors with respect to the placebo and 1 mg/kg arms, the trial could not serve as a registration trial, thereby eliminating Peregrine's opportunity to obtain FDA approval based on the results of the trial alone, nor could the data be part of the registration package when Peregrine sought approval following its planned Phase III trial. (Shan Decl. 118.) At a minimum, due to CSM's errors, what would have been a 400 patient Phase III trial needed to become a 600 patient trial since the data from the 121 patients in the Phase lib trial could not be used as part of Peregrine's registration package. At an average trial cost of $100,000 per patient, CSM has caused Peregrine additional direct damages of $20,000,000. (Shan Decl. 19-22.)
This setback was devastating for Peregrine. Bavituximab's long term benefits may include treating early stage cancers and preventing cancer. Bavituximab also has indications of benefit for many other diseases such as herpes, Hepatitis C and HTV. Peregrine has suffered at least a substantial loss in time to market and is in the process of the larger and more expensive Phase 331 trial. (Shan Decl. 17, 23.)
The nature and magnitude of CSMs errors resulted in Peregrine filing its First Amended Complaint in this matter, alleging claims for breach of contract, negligence, negligence per se, gross negligence, misrepresentation/concealment, and constructive fraud. The exculpatory clauses do not limit Peregrine's recoveries on its claims for relief.
Dunno...but that describes most trading days. There is no reason to trend anyway but sideways. At this point in the company's history, the next significant move will be big in either direction.
When was the Last Quarterly CC, where the PPS did anything but go down?
Maybe earnings will be up based upon Avid bookings that did not invoice last quarter. Not a game changer as a catalyst since this stock doesn't trade on earnings, but one less arrow in the quiver of the bears.
If PPHMP is trading on the open market at $24.15, how is MLV going to sell another $30MM, or 1.2MM shares of Series E preferred at $25.00?
Very interesting comments CP. Are you saying that MMs are NOT exempt from regulations that prohibit naked shorting? I thought that the MMs could short without locating shares if it was in connection with a "bona-fide" market making activity.
Naked shorting is a problem, BUT that is circumvented because intra day it doesn't matter (the position is opened and closes in the main session so that is illegal and only visible to the SEC's new software who can correlate T&S with clearing (which they could not before). And you can not have 1Milj shares traded and only 750K cleared.
Overnight naked shorts is technically possible but then you need at least one broker holding the role of prime broker to cheat (and risk prison). But for the voting then would have to be done on a SPECIFIC day (I think for PPHM it is 15th of August) and it would therefore be easy to visit the log and focus on 14/15/16 of August. If there is a discrepancy it cannot be hidden.
Is it possible that limit orders were placed in extended trading and someone simply decided to grab them? Just offering a hypothetical. I don't fully understand what goes on with the ECNs after hours.
so what logic had it close at 1.86, only to be followed by 1.94 in AH? are you suggesting that some dope placed a 'market' order in after hours? why were today's first trades at 1.95? you just think somebody offered that this morning just in case there's big news? there is no chance that's
They never make it that easy. How about a spike and swipe head-fake, then some substantial news following heavy selling at $3.00?
I think Friday's AH's action and the overall volume pick up towards the end of the week is based on one of two things.
1.) Another run after the recent preferred sales that will be shorted at higher prices.
2.) We actually might get some real substantial news on one or another front.
OPEX wasn't the reason IMO because of the volume leading up and into Friday. I guess we will find out early next week
Preferred buyers hedging makes sense, but how did that drive 80MM in volume? Unless an HFT algo picked up on the buying interest and tried to front run it, starting a snowball effect with day traders and other algo bots piling on... all imo.
CP, respectfully I cannot agree with that reasoning. The up & down ride was literally 2 days right at the beginning of March. Not enough time for people to be disappointed. I tend to agree with the stance Eyebuy was taking...run it up to $3 to allow the buyers of the preferred to hedge their positions.
If this keeps up, the company is in danger of being removed from the list of stocks offered by ShareBuilder. <g>
This volume is unbelievable.
Dividend is $0.66, but $24.00 still seems mispriced. Maybe an opportunity for some kind of convertible arbitrage, but I'm not familiar with those strategies.
Isn't today the ex-date?
Yesterday 400k Preferred Shares Bought@$25, Now $24???Mischief Brewing?eom
What we are seeing is basically an undistorted picture of beneficial interest. Agree that most beneficial owners have already taken their positions, so absent a price catalyst, no more volume than the present should be expected. The problem is that the next time new money starts lining up, the HFT bots will jump in with front running and algo-bot battles, which then draws the day traders in, all of which grossly distorts the actual buying interest, beneficial trading volume, short interest, etc, so the question will then be how much of it is real buying interest and how much just phantom shares going back and forth. Judging from the size of the last run up (still unexplained, btw), the percentage of phantom shares can be rather significant. All imo.
With minor exceptions our volume is squat.
Less than 2 million each day indicates no one cares.
The smart folks that want into this stock already have all they want or can afford. For the most part these folks are waiting for whatever news/progress that happens to get them to point they will sell or start selling. Most of these smart folks have lots of patience and/or a high price target before they will sell.
The people selling are either non gambler type owners or part of a group of day trader types that get their jollies over nickles and dimes. They really don't count in the total picture.
When there is news that really moves (or could) the stock there are some significant holders of our stock that will play games to suit their own interests.
Folks here generally refer to that is "our stock is being manipulated"...No Kidding
Big changes in our volume will come from NEWS.PERIOD.
King and Company have no reason to give a rats fanny about PR's to make cry baby stockholders happy. We'll get news when he wants us to get news and when it's MATERIAL.
Until then KING is doing exactly what he should be doing.....His JOB...get BAVI to market and become a real going enterprise that actually has a product to sell and make some money.
CP - Your analysis is on point. Clearly the CA "Appellant," i.e., adjudicated loser, does not have a winnable case, yet they defiantly persist (with a case thoroughly discredited by the trail court) even with the possibility of sanctions (both monetary and ethical) above and beyond the actual out of pocket costs of perpetuating this spectacle.
Frivolous Lawsuits
With no reasonable expectation of a favorable verdict by the court, one can only wonder why the appellant and the attorney driving this litigious clown car are so bent on throwing a wrench into the machine. PPHM, to their credit, has refused to "settle" on a meritless lawsuit. So with essentially zero chance of monetary reward - and with a rather compelling case for costly sanctions against them - why on earth are the discredited plaintiffs proceeding? What DO they hope to gain from this? Whatever the agenda, it is clearly to the detriment of shareholders, many of whom may be, ironically, members of the "class" the lawsuit purports to "represent." It likewise to the detriment of those who might benefit from the unimpeded progress of a promising cancer therapy. Civil society and the court should find this travesty highly repugnant.
Yes, if all the filing is done in December 2014 then we have a verdict in Q1/2015.
The idea behind this appeal is for sure the following:
1) Plaintiff(s) have every single verdict against them.
2) They got a warning from the Judge to come up with something
3) They didn't come further then reiterating themselves 3 times because they have no grounds or facts to support SEC fraud.
4) They have attempted to harm PPHM by using the trial to disclose information they could find, such as the negotiations between PPHM and AbbVie for the partnership before the Sept 21th dose switching incident, and use the court filing as a vehicle to disclose with which they had no risk of counter measures from PPHM.
With this procedure they will gain nothing and they no it, BUT:
1) They have a new Judge
2) They can harm PPHM by letting a CA hang out there which they know isn't what a company wants.
3) With any other company then PPHM they could have forced in a settlement just to leave them alone. But with this BoD/Management that will not work, non of them will harm their reputation by entering a settlement that will always look like a guilt recognition.
4) They probably hope to find a straw in the further PPHM vs CSM filings. CSM files for sealing and they do it so poorly that one might have thought they did it at purpose, know that the Judge would not agree and go for the "redacted disclosure", which he did on 29th May 2014.
Since CSM once tried to hang their procedure to that of the CA, one could wonder at what extend CSM is hoping to use the CA to linger their case in another x months of delay.
Anyway, if plaintiffs in the CA had a case from the start then they would have had all the material they needed to make their case and there would have been a Class Action at this time. They gambled, probably push by projected damages and settlement amounts by the ambulance-chasing grade law offices involved with these class actions, and in 3 filings never even made the beginning of a case and the Judge whistled them back 3 times.
So they KNOW they don't have a case and they KNOW PPHM knows that too, hence the goal is not to WIN the trial, the goal is something else, says my dog too who's happy to see me!
More details below. Looks like they can easily drag this into 2015.
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
FILED
MAY 29 2014
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
NATHANIEL L. ANDERSON,
Individually and on Behalf of All Others
Similarly Situated,
Plaintiff,
and
JAMES T. FAHEY,
Plaintiff - Appellant,
v.
PEREGRINE PHARMACEUTICALS,
INC.; STEVEN W. KING; PAUL J.
LYTLE; JOSEPH S. SHAN; ROBERT
L. GARNICK,
Defendants - Appellees.
No. 14-55882
D.C. No. 8:12-cv-01647-PSG-FMO
U.S. District Court for Central
California, Santa Ana
TIME SCHEDULE ORDER
The parties shall meet the following time schedule.
If there were reported hearings, the parties shall designate and, if necessary, crossdesignate
the transcripts pursuant to 9th Cir. R. 10-3.1. If there were no reported
hearings, the transcript deadlines do not apply.
Case: 14-55882 05/29/2014 ID: 9113228 DktEntry: 1-4 Page: 2 of 3 (15 of 16)
Thu., June 5, 2014 Mediation Questionnaire due. If your registration for
Appellate ECF is confirmed after this date, the
Mediation Questionnaire is due within one day of
receiving the email from PACER confirming your
registration.
Mon., June 30, 2014 Transcript shall be ordered.
Mon., September 29, 2014 Transcript shall be filed by court reporter.
Mon., November 10, 2014 Appellant's opening brief and excerpts of record shall
be served and filed pursuant to FRAP 32 and 9th Cir.
R. 32-1.
Wed., December 10, 2014 Appellee's answering brief and excerpts of record
shall be served and filed pursuant to FRAP 32 and
9th Cir. R. 32-1.
The optional appellant's reply brief shall be filed and served within fourteen
days of service of the appellee's brief, pursuant to FRAP 32 and 9th Cir. R.
32-1.
Failure of the appellant to comply with the Time Schedule Order will result in
automatic dismissal of the appeal. See 9th Cir. R. 42-1.
FOR THE COURT:
Molly C. Dwyer
Clerk of Court
Blanca Gurule
Deputy Clerk
PACER. I posted the docket record earlier.
Back as an appeal, one presumes. Hopefully, the Appellate Court rejects the application.
There is a new case link on PACER which leads to the following..
Court of Appeals Docket #: 14-55882 Docketed: 05/29/2014
Nature of Suit: 3850 Securities, Commodities, Exchange
Nathaniel Anderson, et al v. Peregrine Pharmaceuticals, Inc, et al
Appeal From: U.S. District Court for Central California, Santa Ana
Fee Status: Paid
Case Type Information:
1) civil
2) private
3) null
Originating Court Information:
District: 0973-8 : 8:12-cv-01647-PSG-FMO
Court Reporter: Blanca Carvajal
Trial Judge: Philip S. Gutierrez, District Judge
Date Filed: 09/28/2012
Date Order/Judgment: Date Order/Judgment EOD: Date NOA Filed: Date Rec'd COA:
05/01/2014 05/02/2014 05/29/2014 05/29/2014
It is on PACER opened as new case entry, which directs you to the appeal...
Court of Appeals Docket #: 14-55882 Docketed: 05/29/2014
Nature of Suit: 3850 Securities, Commodities, Exchange
Nathaniel Anderson, et al v. Peregrine Pharmaceuticals, Inc, et al
Appeal From: U.S. District Court for Central California, Santa Ana
Fee Status: Paid
Case Type Information:
1) civil
2) private
3) null
Originating Court Information:
District: 0973-8 : 8:12-cv-01647-PSG-FMO
Court Reporter: Blanca Carvajal
Trial Judge: Philip S. Gutierrez, District Judge
Date Filed: 09/28/2012
Date Order/Judgment: Date Order/Judgment EOD: Date NOA Filed: Date Rec'd COA:
05/01/2014 05/02/2014 05/29/2014 05/29/2014
Class Action suit notice of appeal filed on 5/29. Given the utter frivolousness of the case as demonstrated by the Trial Court's multiple dismissals of the twice amended complaint, one has to wonder precisely why the plaintiffs attorney calculates that she can "elicit" a settlement through such vexatious machinations. Surely, she can not reasonably anticipate that the Court will ultimately rule in her favor on the merits of this nonsense.
Moreover, since the plaintiffs appear to have had inside knowledge about the partnership discussions with AbbVie, one has to wonder precisely why they now appear to calculate that company would buy them off simply to avoid further legal delays. (It would be ridiculous to conclude that the company fears an adverse ruling.)
Given the tenor of the Trial Court's memorandum dismissing the thrice discredited complaint, shareholders should hope that the company moves for judicial sanctions against this sham litigation.
As a matter of sound public policy, courts need to put an end to this kind of flimflam crap!
Looks like some PPS moment heading into June...
Well how about that?
CP, agreed that oncology has a different paradigm than other pharma indications, but a successful market launch still appears to be a complicated endeavor. Just wondering how many industry veterans Peregrine has, or will have, on staff to address the challenges after FDA approval. It seems to me that an alliance with an established oncology franchise would at minimum improve or expedite access to opinion leaders, perscribers, and payers.
I found the following paper on the subject informative, so I thought I'd share it with the group:
IMS ONCOLOGY LAUNCH EXCELLENCE STUDY
This being said, there will of course be some marketing cost. Conventions, Presentations, papers and spreading the word in all possible ways but very probably not the door to door REP doctor visiting, samples distribution, and "try it" stuff.
One thing the company has in its favor in "going at it alone" is existing manufacturing capability and expertise. But the most compelling reason for a partner is marketing: for that you need "big" pharma wherewithal. I also expect a partnership and that the partner makes a bid for the company sometime during the Sunrise trial. In the meantime, it would be nice to have some kind of update from management, but something tells me that we don't hear anything until June. All imo.
Great Post CP. There is no greater risk going it alone. The only risks are that Bavi is not safe or Bavi does not work. We KNOW that Bavi is safe and that Bavi works! As with all drugs Bavi works better in some combinations and in some indications. We know that and will proceed in the indications and combinations which are known to be very good.(eg.NSCLC and breast!). These indications ALONE will produce multi-billion dollar revenues. Meanwhile the IST's and preclinical trials will point to further indications and combinations.
I expect a partnership and a buy-out...but both will be very good for PPHM shareholders...and IMO many times better than the ABBI potential deal. Once again great post CP!
CP, all good points, but dilution since the dose switching fiasco coupled with the loss of the (non-dilutive) bank loan, and the uncertainty regarding future dilutive financings surely have an impact on the current PPS. Long term, in theory, some of the dilution should find its way back into owner equity as ROI on the working capital raised, but for now the PPS languishes at $1.68, when it could be as high as $4.66 (my WAG) with more clarity on future financing...even without a partner "officially" on board. All IMO. I welcome the comments of you and others on my "rosy scenario" potential present valuation.
coporal, I don't know about the others but you can count me amongst those that, with hindsight because i didn't know it at the time, find that not partnering of PPHM in 2012 with Abbot Labs (AbbVie) or whoever else for that matter, is a good thing.
NOT because the reason of that was the "dose switching" incident. I find that also an unfortunate event I would have preferred not to happen, although AGAIN with hindsight, knowing today what/who the "dose switching" exactly occurred and that it was DISADVANTAGE to Bavituximab, and intentional, and not HELPING Bavituximab, I am AGAIN glad that we didn't partner on those Sept 7th results.
Last but not least, and again with hindsight, the fact that we only AFTER the dose switching (and the potential partnering point in time) did get BETTER understanding of Bavituximab's MOA, based on PII results amongst others, is also a reason I am glad we didn't partner at the time.
It is UNDENIABLE that whatever partnership would have come out of it, it would have been based on a disadvantage situation compared to today.
- Wrong and lower then SOC beating scores then due because of the dose switching (=higer risk) on which we would not have cashed.
- A understanding of the MOA with reduced potential outlook then today on which we would not have cashed.
- The, for sure, terms and price based on the risk of not getting PIII design approval, which we have in our pocket today.
- No FDA granted Fast Track that we have today and which we can leverage.
- Vulnerable because at a moment our poison pill was disabled by a loan and its terms.
- Unflexible in negotiation because partial assets were encumbered by the loan.
- Vulnerable for unforeseen events because alternative emergency financing such as ATM, forbidden by loan terms, putting us completely at the mercy of a BP and a proven (on 26th Sept 2012) greedy financing company that couldn't care less about PPHM, Science or patients as long as it makes it fat profits. They didn't even wait for the results of the dose switching investigation who with hindsight were in Bavi's and PPHM favour.
I pass for such to early breadcrumb-grade partnership. BP's hunt for them. Every BP that has a minimum of educated scientists, and they all have, understand that the data we presented on Sept 2012 proves today to be correct and even BETTER. So if no renewed partnership continuation talks came from it it is because BP now stands before a new and much more expensive situation.
The FAT is of the SOUP for them because PPHM now has 80Milj$ cash, no creditors and so no risk on bankruptcy, 100% unencumbered control over its IP and pipeline and hand free negotiations. No longer going concern, Top Notch KOLs (Key Opinion Leaders in Oncology), 1500+ publications and peer review, Bavi PIII up and recruiting with at the key TWO early look-ins, a data monitoring committee watching for early trial stop, granted FDA Fast Track and super results for Breast, pre-clinical Bavi+Yervoy, Bavi+radio Therapy, etc.
So YES I am glad they didn't partner, and if we would have we could have had a better pps today (I used 50$ and you took me on that even thought you knew it was an example based on prices others named and I wrote to be glad we were not a 50$ stock because it would have meant we would have partnered to early and you wronged it into something completely different).
YES, we will be MUCH better off with how things go now and evolve every day. PPHM is in its strongest position EVER and all that is thanks to the fact they had the NERVE NOT to PARTNER. The pps is irrelevant because it is a snap-shot! Not the intended/expected end result when the work is done.
I am an investor, I think long term. I am in a small cap Biotech because:
A) I understood what they do and what potential this had (now has)
B) Knowing the results were not to be expected in 5/10 years (it's actually from J Kramer I had that because he looked at TCLN/PPHM in a VERY early stage).
C) because if I have/wanted to put some money in risk this was the one with the highest Risk/Reward ratio.
D) because I was looking for a stock that had that Microsoft/Volkswagen/Qualcom BOOM potential and assessed PPHM was that stock for me (and today I don't even doubt that I was right about that choice).
YES, I am EXTREMELY HAPPY they didn't partner with AbbVie or any other BP in Sept 2012.
YES, I am EXTREMELY HAPPY they didn't partner all these years SK was talking about partnership because it would have been for breadcrumbs or at least severely under valued and not BOOM.
YES, I am EXTREMELY HAPPY it takes time now too to partner because because currently we get almost new insights and potential of the Bavi pipeline now that the workings of phosphatidylserine (PS) serine are understood in viral, oncology, inflammations, etc and that we hold all the PS targeting rights via patents.
YES, I would still be HAPPY if they would have the nerves to go it alone, although I fear this may not happen and we will indeed see some deals with PPHM this year, but NON of them will involve a change of control of the company (IMO), and that makes me EXTREMELY HAPPY.
Maybe it was short covering. They always seem to know when to close their positions.
NasdaqShows 439,131Shares Traded@CloseOfDay. Nearly Half TotalVolume...
Luckily it was unable to drop to PPS.
GLTA!
Two big PPS game changers imo: a partner or an announcement from management that there will be no more dilutive financing. Can't underestimate the impact of dilution on investor sentiment: any gains made have been absorbed.
They have said that they are busy with partnership and collaboration discussions. I believe that this is the case. They will not announce how these discussions are proceeding until they are completed. I agree that this will be big news and a real game changer.
You are mixing apples and bananas, imo. Institutional ownership is based on common stock only. That's not to say that institutions don't own some if not most of the preferred shares, but it could be viewed as similar to institutions holding bonds in their portfolio.
Question on Institutional ownership. I believe Cheynew recently reported we are 17%. Does this take into account the recent preferred offering? If not, wouldn't that increase the overall percentage of ownership to a much higher number?
Take out the noise from the bots and you get the real picture on buying and selling interest, which lately is a stalemate.
If Zacks does that they reduce buyers competition. We've seen that many big fish have been feeding on PPHM shares and apparently place them on the shelf. That cause liquidity problems.
Low volumes are VERY difficult to trade for boxes because they often end up against the algo's of Market Makers rather then against the average broker that is filling Jane and Joe Do.
Note to BOD: If you sell to BMY, kindly ensure that the value of all IP is reflected in the sale price.
I would take a clue on time of PPHM option exercising from the BMY takeover of MEDX.
The last really inexpensive options were granted to BOD and top management of MEDX while share prices of TO offer were being negotiated, later to be refused as too low. Options vested on change of control. When merger/TO completed, all those with options vested sold within a day or two. Nice profit for all.
PPHM $1.76....BRK-A: $191,349.81 Underperforming yet another invidious comparison..
The sky must be falling!
Today's Trading In PPHM: Underperforming IBB
Today PPHM is underperforming the Nasdaq Index by approximaletly 3.76%.
PPHM continues to be very weak ... Buyers are nowhere to be seen in the book ... while prices drops as sellers try to unload their Shares.
In addition, Tomorrow PPHM could collapse ... once it becomes evidend the Company will not be at ASCO this year (this is my guess).
Time will tell ... but it looks like everyone is bailing out on this Name!
Yes, but the BOD is the Schrödinger's Cat.**
"Bavituximab is the Higgs boson of Biotechnology"
Sad but true. Funny thing is that short interest is relatively low (at least as of the last reporting), and instead the price appears to be fading down because of low buyer interest. Looks like anyone interested in the company has already taken a position.
Shorts.
Nice volume! No doubt keeping the traders at ShareBuilder very busy today.