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You may have a point with your semantics, but you could probably delete the adjective "early" with the same effect. OTOH, in a world where lawyers frequently run the settlement clock down to the final second, wouldn't any time before the morning of trial be considered "early?"
Good grief, folks---the time for EARLY settlement has long passed.
New definition of "early"?
Or maybe CSM indicated they want to settle and are pushing everything out to avoid discovery. Otherwise, why would Peregrine let them off the hook? All imo.
MORE DELAYS IN THE CSM SUIT. TRIAL NOW MOVED FROM 4/14/15 TO 6/16/14. Possibly they are setting the dates beyond the class action suit to prevent disclosure of information?
Attorneys for Defendant Clinical Supplies Management, Inc.
UNITED STATES DISTRICT COURT
CENTRAL DISTRICT OF CALIFORNIA
PEREGRINE PHARMACEUTICALS, INC., a Delaware Corporation,
Plaintiff,
vs.
CLINICAL SUPPLIES MANAGEMENT, INC., a North Dakota Corporation,
Defendant.
Case No. 8:12-cv-01608-JGB-AN
ORDER TO AMEND SCHEDULING ORDER
[Filed Concurrently with Stipulation to Amend Scheduling Order]
Complaint Served:
1/17/13
Trial Date:
4/14/15
Upon consideration of the Stipulation to Amend the Scheduling Order dated February 28, 2014 submitted by Plaintiff Peregrine Pharmaceuticals, Inc. and Defendant Clinical Supplies Management, Inc.; and upon consideration of all documents, files, and pleadings in this action; and upon good cause shown, it is hereby ORDERED that:
1. Plaintiff Peregrine Pharmaceuticals, Inc. and Defendant Clinical Supplies Management, Inc.’s stipulation to amend the Scheduling Order is GRANTED; and
2. The Scheduling Order dated February 28, 2014 is amended as set forth below:
EVENT
CURRENT DATE
PROPOSED DATE
Deadline for Initial Designation of Expert Witnesses
12/15/14
3/2/15
Deadline for Designation of Rebuttal Expert Witnesses
1/26/15
4/6/15
All Discovery Cut-Off (including hearing of discovery motions)15
2/23/15
5/4/15
Dispositive Motion Hearing Cut-Off
3/2/15
5/11/15
Last day to Conduct Settlement Conference
3/16/15
5/26/15
Case 8:12-cv-01608-JGB-AN Document 50 Filed 12/01/14 Page 2 of 3 Page ID #:642
Final Pre-Trial Conference
3/30/15
6/8/15
Jury Trial
4/14/15
6/16/15
IT IS SO ORDERED.
Dated: December 1, 2014 __________________________________
Honorable Jesus G. Bernal
United States District Court Judge
Not much time left for the calendar year, unless of course there is a grand conspiracy to scoop up all the shares from tax selling with late breaking news. ;) Precisely which year SK was referring would be interesting point for clarification during the CC. All imo.
"We look forward to updating you as these deals come to fruition over the coming year"
I guess he meant fiscal year. Okie dokie...another 3 months it is. Then we get the pitchforks IMO.
CP - Good point on the many tangibles that can be readily quantified. There is also additional phase III patient enrollment good for at least $20MM. If there is any hint of sabotage or deliberate tampering, it's hard to imagine CSM wanting to engage in discovery, so maybe there will be an early settlement. All imo.
I agree. PPHM will NEVER produce that paperwork and I am almost sure they will not make many claims at all as to things they can't make hard true invoices etc.
If I am the Judge then I'd say having the paperwork on AbbVie doesn't prove that AbbVie would have signed it, even if AbbVie declared for the court that a date was set to do so, even then THEY cannot say that 5 min before signing a sudden event could have made them (or even PPHM) change their minds.
The time-to-market that is another thing. Their PPHM can PROVE that the FDA approved (even the sabotaged) data ( so no one can question the fact the FDA might maybe not have approved it) and that this approval was delayed by that investigation, the vials recall etc. That is tangible. But this delay cannot be before (on or about) Sept 20th or extend after the EOPII meeting was held.
The same for the REAL cost of the investigation, losses due to the loan pay-back and forced to use the ATM after Sept 24th below 2$ to compensate for the loan rather then at the 5.40$ before Sept 24th.
I think that the fact that the Judged ruled that the damages cannot be limited in the case of constructed fraud may have changed the mindset with CSM. They know they'll get at least constructed fraud on their hands, so maybe they settle this time.
alternatepatel- it's way out of my depth to try to predict. But we can probably expect CSM to delay as long as possible.
skweze
What are your guesstimates regarding court's timing of ruling and fine on CSM ?
Can the final verdict be delayed beyond April 2015 ?
What is the minimum that PPHM would likely gain ?
No argument that there are too many attorneys out there who encourage witnesses to "adjust" testimony to conform to their case. But in this particular instance the figures cited appear to be reasonable on their face. That clinical trial cost and delays are very expensive seems a rather uncontroversial proposition. Also, there is nothing in the record that would suggest that the lawyers for Peregrine are anything but straight shooters. All imo.
Lawsuit declarations
One should be very careful when putting any "FACT" status on what is in a Declaration.
The attorneys write for folks to sign. The latitude taken with the truth is amazing.
CP - It certainly seems that there is sizable sum in play. Cheynew posted the trial timetable earlier today. If CSM wants to avoid discovery through settlement, it looks like it would be very early 2015. Otherwise, the cut off for a settlement conference is 3/16/2015. Considering the other hot topics of discussion lately, it looks like there may be quite a few things converging in 1Q 2015!
Deadline for Initial Designation of
Expert Witnesses: 12/15/14
Deadline for Designation of Rebuttal
Expert Witnesses: 1/26/15
All Discovery Cut-Off (including
hearing of discovery motions):
2/23/2015
Dispositive Motion Hearing Cut-Off:
3/2/2015 at 9:00 a.m.
Last day to Conduct Settlement
Conference: 3/16/2015
Final Pre-Trial Conference: 3/30/2015
at 11:00 AM
Jury Trial: April 14, 2015 at 09:00 AM
Trial Estimate: 10 Day(s)
This case is set for trial before the Honorable Jesus G. Bernal, Courtroom 1,
United States District Court, 3470 Twelfth Street, 2nd Floor, Riverside, California.
The lawsuit against CSM also provides another interesting wrinkle in this drama. In CSM's Motion For Summary Judgement, the court found that regardless of any Limitation of Damages Clauses in the CSM Master Services Agreement, CSM is still open to unlimited liability for active negligence, negligent misrepresentation, and constructive fraud. In the supporting court filings, Peregrine detailed some costs surrounding this debacle including a botched phase II study ($12MM +), additional patient enrollment in phase III ($20MM+), and at least six months loss of time to market. Further, had the original phase II results been confirmed it "likely would have shaved at least 3 to 4 years from the program and resulted in early commercial sales."
A potential damage award would appear to be in the tens of millions. And based upon the nature of the claims against CSM, one ventures that they would want to settle rather than be subject to discovery and examination of the offending actors under oath. Just a thought, but a sudden influx of tens of millions in cash on top of PPHMs existing cash position vs. the current SP/Market Cap would seem to invite a takeover attempt.
All imo.
From declaration of Joseph Shan:
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.
You make a very compelling point. The class action suit was roundly discredited by the trial judge. Moreover, to even a layperson, it is clearly grounded in sophomoric legal reasoning. Therefore it is hard to fathom why anyone would to throw good money after bad with a case that faces almost certain doom when it finally does reach the appellate court judges. (Not to mention the risk of sanctions for a frivolous action.) Peregrine has already made it clear they will not "settle" with the plaintiff. So with basically zero hope of direct financial reward, one does wonder why the plaintiff so stubbornly persists in keeping the case on the docket for as long as possible. All imo.
The ongoing class action is the only reason that an entity would be able to acquire shares over the past 2 years without filing a form 13. As poster R239244094042 pointed out, a position can be kept if filed for confidential treatment. I have legal friends who have confirmed it's quite possible that an ongoing class action would be sufficient for such treatment. However, if there is an ongoing acquisition of shares, a quarterly update must be filed showing an ongoing intent to acquire shares. Interestingly enough, at least once every quarter for the last 2 years we've had days of large volume for no apparent reason. Ebola was the latest. I expect there will be one in January also.
So buy if you think it's low, sell if you think it's high.
Share price is fact.
Hard to tell without more detail. Some have argued that pending legal matters give management a pretext to hold information closer to the vest then normal. All imo.
Maybe the defense is complicit in the extension.
Waah is not an argument.
RE "$20/share seems very fair today"
Incorrect. Actually $1.41 is very fair today. That's the price where willing buyers meet willing sellers.
It would be interesting to know why the briefing schedule was extended. Plaintiff doesn't have a case and appears to be slow walking this to maximize the time until it gets dismissed. Looks like plaintiff perceives some value to being a "wrench in the machine".
In 2 weeks we'll see more on the class action suit. The Plaintiff's brief is due 12/15.
The briefing schedule previously set by the court is revised as follows: appellant shall file an opening brief on or before December 15, 2014; appellees shall file an answering brief on or before January 30, 2015; appellant may file an optional reply brief on or before February 27, 2015. [9300197] (SM) [Entered: 11/03/2014 04:55 PM]
$20/share seems very fair today, provided it's not proximate to positive Sunrise data.
AVNR is acquired for $3.6 Billion. Porkchop, do you think this is a fair amount for Peregrine? It would amount to approximately $20/share for PPHM.
It would be interesting to know why the briefing schedule was extended..and who initially moved to extend it.
The class action provides the perfect cover to keep quiet.
But not completely heretical assuming that a deal was struck prior to release of Phase III results. If the Phase III results come back favorable, then it's a game changer and $13 would seem paltry.
Skweze, be careful. Talk like that is blasphemous.
However, if 12 months from now Phase III continues to be strong and showing no issues (aka Garnick pulling the plug) the market cap should be increasing towards a more justifiable dollar amount. But, we really should know the fruition to which King stated partnerships would be updated by then - if indeed he does follow up with that promise.
There may not have been a confirmation on record by PPHM that Abbvie was at the table. But if you couple the claims in the CA with the declaration by in the suit against CSM, namely, "With the anticipated success of this trial, Peregrine expected to promptly partner with or be acquired by a global pharmaceutical company.." it doesn't seem to be an unreasonable inference.
Abbvie was at the table in 2012 for a partnership with Peregrine, please go back and read all the court documents and you will see it plain as day. The difference is that neither side denied the statements that Abbvie was at the table, nor the traveling to Abbvie by SK to try and hold the pieces of the partnership together, because that would be illegal (to deny those facts) and to lie on court statements.
$13/share in the next year would be reasonable...even $12.
BMY purchased MEDX for around $2.4 Billion, which would equate to around $13/share with the current number of OS for PPHM.
If some entity purchased Peregrine for $2.4 Billion in less than a year, I would have absolutely no complaints. I know many on this board wouldn't even consider that valuation to be worthy. Some here believe that a "bread crumb" valuation would put the PPS well over $130/share.
Who knows, maybe the Market and the World will realize "Soon" what a "Hidden Gem" Peregrine is.
CP - I think the BOD has done a remarkable job of keeping the company financed and ahead of the burn rate. My point was simply that the metrics an investment banker uses for optimal ROI may be different than a private investor.
And if you are referring to ES with "investment bankers" then remember he saved the company we it needed it the most. So even if you would just get 1$ for your PPHM shares, instead of 0$ if he wouldn't have save the company, it is thanks to ES, the investment banker :)
Cheap is a relative term, but with the BOD controlled by investment bankers, it certainly possible, and perhaps even predictable, that their cash out number is lower than the expectation of many longs. Having said that, I imagine that ROI vs free cash is a topic subject to vigorous debate and highly subject to individual investment objectives. I think the biggest concern in a MEDX like scenario is that nascent intellectual property is given away with the developed product. All imo.
A cheap buyout is my main concern regarding PPHM. Me, just like some of you , have also suffered a "cheap" buyout of anothe Co. I was a shareholder. The buyout was terrible for shareholders but I suppose great for the BoD. This is a point that we shareholders should focus on and take the necessary steps for that not to happen. Which ones? I dont know
North40000 - I was actually thinking specifically of MEDX. In many ways, PPHM seems to be following the same trajectory.
You have the correct answer,skweze. Witness the multiple class action suits brought by numerous shareholders against BMY/MEDX because MEDX board agreed to BMY TO's serious undervaluation of MEDX shares at $16/share. Consolidated in N.J at the time, both state and Federal---the latter deferred to J.Jacobsen in state court in Trenton.Bungler and hump4
can confirm deails.
A number of us here were deprived of serious money on that one.
Maybe not a partnership in the traditional sense, but an outright buyout perceived by some to be under-priced, say for example $8.00/share. All imo.
It was a thought I had based on my research that the specific exclusive statement within the by-laws is often added when there is going to be a merger or acquisition. However, in almost all cases that amendment is definitely added to decrease the number of shareholder lawsuits due to these mergers and acquisitions. Unfortunately, I have no idea why a Partnership would cause an increase in Lawsuits...
IMO, the changes look like they could be preemptive in nature. Is the BOD expecting a hostile takeover bid? If that is the case, it is certainly good news for shareholders. Takeovers happen when a very sophisticated entity knows that a company is significantly undervalued, and would confirm the feeling of many longs that the current SP/Market Cap is simply too low.
There were two changes to the BY-LAW which I noticed. You are only commenting on one aspect of the change which pertains to the changes technically is more beneficial to management and the company than the shareholders. You simply only posted about this portion of the by-law change:
Quote:
establish advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and for proposals to be brought by stockholders before any meeting of the Company’s stockholders; and
The other bylaw change is the more important one:
Quote:
establish a forum provision that provides that, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Company to the Company or the Company’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, the certificate of incorporation or the bylaws of the Company, or (iv) any action asserting a claim governed by the internal affairs doctrine. The provision further provides that any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Company shall be deemed to have notice of and consented to the provision.
Not an expert, but apparently there is a very small number BSL-4 labs (in the U.S.) from which to make a guess, with the only private one located in Texas.
What is the significance?
All imo.
I wonder where the subcontract facilities are located.
Looks like they are just trying to delay a ruling by the Court that puts and end to this nonsense for good. Others have suggested that the CA case is insignificant to Peregrine's progress, but if that were truly the case, why is the CA attorney clinging to this doomed travesty of justice with everything that she has and slow walking it the entire way?
All imo.
Interesting they also tacked on an additional 15 days for PPHM to respond. Previously they had 30 days, now 45. The plaintiff then also gets another 30 days instead of 15 for a final rebuttal. So the total add on to this pain in the ass suit is 60 days.
Looks like the Class Action Clowns have been granted more time to deliver nothing:
The briefing schedule previously set by the court is revised as follows:
appellant shall file an opening brief on or before December 15, 2014; appellees shall file an answering brief on or before January 30, 2015; appellant may file an optional reply brief on or before February 27, 2015.
Technical Analysis of the unusual lunch hour trading: LOL
All imo.
Interesting that this is happening over lunch. Either "somebody" is being messed with, or something else is afoot. All imo, of course.
PPHM HOD 1.60$ and Quite Quiet on the PPHM board :)
Normally we have people calling the PPS by the minute.
Now the HOD is 1.60$ and we can hear a mouse run.
Some will need an even bigger crew then they might think.
Time, time, time.
And why would this be happening?
Will the PPS fall back down after lunch?
In pleadings related to the CSM lawsuit, Joesph Shan stated a cost of $100,000 per patient.
Not a bad thought. Back into the enrollment number from the financials. Probably hard to do though.
Is it my imagination, or did PPHM give a cost prediction based on enrollment back last Dec?
Didn't DTRA spend approx $24MM (not sure of exact amount, but it is on record), including an optional extension of the base period, out of a $36MM cap on the entire contract? While they may not have spent every penny of the maximum budget amount, it doesn't seem accurate to say they "scrapped" the program.
DTRA had budget problems.
There is no publication date in the paper but a footnote references an article in July/Aug 2014 mAbs, so the paper would appear to be very recent.
This study has shown that the PS-targeting antibody, PGN401, binds to EBOV-infected cells and to purified EBOV virions. Due to PGN401 having been used for several human clinical trials in cancer, from Phase I to III [13, 20, 21], its repurposing of use for filovirus therapy through licensure or emergency use may present an attractive option...
Footnotes: 21. Reichert, J.M., Antibodies to watch in 2014: Mid-year update. MAbs, 2014. 6(4): 337 p. 799-802.
How old is this ? Can't find a date
Are you suggesting they hire a caveman or a small lizard as a spokesperson?
Yes very quietly. Too quietly
By no means a darling of the "Financial Media" (yet), but Bavi is on the right radar screens..progress continues quietly.
Antibodies to watch in 2014 Mid-year update
The below paper appears to show promise. Perhaps management will have an update on the progress of anti-viral programs at the ASM.
Effective binding of a phosphatidylserine-targeting antibody to Ebola virus infected cells and purified virions
Let's hope they score at least a ten bagger!
Someone took a flyer on 145 Nov $2 calls for a nickle. Hoping for good liver news I assume.
Been waiting awhile now for a bullish indicator. Now we have one! When is the launch?
Glorious day to be a Peregrine shareholder.
I have been busy gathering and reclaiming parts from previous PPHM space-like vehicles in preparation for a future bigger and better infinity and beyond launch. I've hired old Zeb down in the Hollar to help me custom build the next bigger and better vehicle. Zeb has helped me build a few of my explosive stills.
Jus so you knows...I will be ready when the time comes. I keeps look in' at them stars and they says git to buildin' now!
On the bright side the number of posts with the standard basher narrative seem to be on the rise, and that kind of crap always seems to precede a nice spike in price. I'll be more confident if AF suddenly piles on, though.
Agree with most of your comments, but how is the s/p "artificially" depressed? It looks like there is simply no volume right now. What I find perplexing is the huge spike in volume and s/p in March followed by an abrupt crash in volume that has continued since.
We can't dispute that Peregrine has made a huge progress in those 12 years since many here invested based on information and ideas of that specific time frame.
I am not stating that I am thrilled with present s/p but I am more than excited to see this huge potential slowly unfolding in front of our eyes.
I should have said "astronomical" potential, especially considering this artificially depressed s/p.
Hope is not a strategy.
The only intent here is to get management to produce some solid results instead of producing only HOPE like they have been doing for years.
Up $0.0002 in AH going into a weekend. No doubt the shorts will lose some sleep over this.