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I think if a partnership is ready to be made.... the BP gets what they want. $75,000,000 in shares and one of the largest stakeholders in the company. Would you agree that shares will be sold between $1.50 - $5.00 to a BP?
"MOS" still has not been PR'd for any ongoing trials
Top 10 selling oncology drugs:
http://www.fiercepharma.com/special-reports/top-10-best-selling-cancer-drugs/top-10-best-selling-cancer-drugs
Its amazing...these are the top 3 best sellers(as of May 15,2012)
1)Rituxan -3B in sales
2)Avastin -2.66B in sales
3)Herceptin -1.66B in sales
Its amazing these 3 drugs were all part of Genentech and more importantly.... Dr. Garnick was responsible for all top 3 drugs that he walked into the FDA and out with approval. How did Peregrine recruit Garnick? The science behind Bavi he seen firsthand and do you think he is going to walk a drug into the FDA halls that is "less" effective than Avastin? I don't think so
Sorry for those who have read this article below... but one article I like about the Garnick hiring:
http://www.minyanville.com/businessmarkets/articles/peregrine-pharmaceuticals-bavituximab-robert-garnick-steven/6/29/2011/id/35458
"Navigating the regulatory waters alone can be daunting for a small company. But Peregrine has a seasoned skipper for the important job: Robert Garnick, a 24-year veteran of Genentech. In his two decades at the biotech company (now part of Roche), Garnick oversaw 17 product approvals, including for top-selling drugs Rituxan, Herceptin, Avastin, and Lucentis."
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If you just look at the many years at Genentech it took to bring along their top drugs... Bavituximab is no different.
http://www.fundinguniverse.com/company-histories/genentech-inc-history/
Exercise stock options re: insider trading....
This whitepaper I found was an interesting read
http://www.insidertradingvideos.com/insider_trading_whitepaper.cfm
IV. Insider Trading Applies to Stock Options and Company Stock in 401(k)
"If you exercise stock options when you know material non-public information, the exercise itself is not a violation, according to most experts. However, if you subsequently sell stock into the market in connection with the exercise of the options, which happens with a cashless exercise/same-day sale, the Rule 10b-5 insider trading prohibition is triggered as with any stock sale. Even after you leave the company, such as in any post-termination exercise period, the insider trading rules apply."
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Its all about the percentages....
I am going to assume $75M in shares is headed to a BP
if purchased at the low end $1.50 ... about 50M shares... about 30% of the company ...(50M) / (132M+50M)
if purchased at the high end $5.00 ... about 15M shares... about 10% of the company ... (15M) / (132M+15M)
Thats the rough estimates... but I don't see these a deal for much less than 1.50 and not more than 5...and I don't see a BP being happy with just 10% ownership of the company
$1.50 is where the BP would buy in... rather than the $5 range and we just so happened to drop from $5 to $1 level as it is seeming to all play itself out
The drop in price and internal investigation was not right....and thats where much of the anger surely originates from with many investors but that is why the risk/reward in this field is just that... risky
just so happens the risk/reward just became stock option rewards for the employees....
just so happens the price is right for a BP to accumulate about 30% of the company but that would need to happen within the 1st couple weeks of the new year since I don't foresee this stock staying below $1.50 for much longer
Happy New Year to all and getting ready for some snow shoveling in the morning... maybe next year I can afford to hire a plow truck!
"...maybe a BP is not really confident with big investors with some 'reputation' ! Dart, Ayer have show signs of instability, in this stock or other stock, and may be seen as loose guns if one day they could influence a critical vote."
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CP... I would agree with that assumption. If Dart.. Ayer want to try and gain more voting power... so be it! Let the buying begin : )
In all honesty.... as was said before.... biotech stocks are all about the risk/reward. Many of us have taken the risk for many years on this one... and the reward just may be around the corner (again... and for the last time).
There are fees associated with a loan payback advantage as well as everyone knows. Now you going to disclose to the bank the 3rd party the competing BP's waiting .....imho you stick with MLV because a loan will further require conditions...upon more conditions.
Outstanding shares not an issue
MLV vs loan is not the issue
The only issue is Bavi science works...and I think the internal review is just about complete since stock options have been awarded and now $100M ready to be used as leverage for shares being sold to that patiently waiting BP and the addition of 2 board seats.
Good point!... 1st set of options exercise date: 3/27/2013
I know their was a disclaimer about 8 equal cash ins of their stock over a 2 year period
For the 250,000 shares... gives 31,250 shares cashed in
For the 150,000 shares... gives 18,750 shares cashed in
Now the fact that they "have" to do this in 8 equal cash ins vs... saving the entire alloted shares to be exercised at anytime within the 2 year period.
I don't see how the stock options and $75M on top of the $100M currently can be considered negative
Do they use MLV simply because they have always been involved in the past? I don't even know if it was possible "not" to use MLV?
Lets say they didn't.... who would they go to ? Someone new and does Peregrine want to open up any chance of their partnering plans with another group of people
For now.... I know they have to pay a % fee to MLV... but my only guess would be they wanted the information to stay within a group they have a relationship with already and I'm sure the process was much quicker using MLV. Additionally... the % fee may just be a little payback for being there for them in the past
Just my opinion...all I do know is they surely didn't "need" this $75M as they had $100M ready at their disposal. Just maybe the BP's are asking for more ... as we ask for more upfront money....and something is brewin in Tustin... lets just hope we like the taste of it!
..."Please tell me what this company and management team has accomplished that would lead you to believe that they even have the smallest amount of consideration for their shareholders?"
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I do understand the frustration and I can't "honestly" name one biotech that has much consideration for their shareholders.
For one... there are no shareholders without a drug that works and there is generally not a "major drug" ( that would wipe out BILLIONS of profits for competing BP's ) that I can think of that makes shareholders the priority over the "art" of taking a major drug to market.
Ok... I guess I will call this "the art" of taking a major drug to market.... because
ready for this? because.... life is not fair for us retail shareholders but that only until we decide to play ball with the big boys.... and with a 2nd offering in the works.... it looks like we will try and finish the game.
They only have to be in partnering talks... IMHO they don't need an official Phase III to do some maneuvering
A competing BP enters the picture as they sit idle all along... and willing to give more leeway to Peregrine and that includes upfront money for security for some reluctantly cheap shares ( hence the secondary offering )
So be it.... "do what it takes" playing with the big boys...
Our day will be a coming
My own internal review... came to the conclusion that Peregrine could always give the BP a % of the company but whats the problem with this scenario?
The BP in talks delays their profits until sales start coming in. This is not an acceptable risk for the BP
The BP is given $$$ Millions in cheap shares... but we had a large amount of shares available already ? Regional partnerships make sense where we need plenty in the reserve tank for payouts for Cotara... as well as Bavi Partners... and now we may need to break that up into regions for additional payouts to BP's.
Its going to be one hell of a 2013!
I think after everyone reviews all scenarios that they will agree that this is all part of a much larger opportunity to finally inking a partnership deal. The partnership deal is all about money for the opposite BP as well ... so them gaining a little foothold of the company at anything under $10 is a steal.
Retired at 45... very nice! I hope all longs have that opportunity. Its been a long time coming for many of us and ironically... many of us have grown our shares to a point where it would have never happened if the stock went north for good just 6 months ago.
GLTA!
Correct! : ) ARNA went from 146M outstanding shares in quarter 3 of 2011.... to 217M outstanding shares to quarter 3 2012 of 217M outstanding shares! ( may be higher now )
Yes... one argument is we all just wish we could "do what it takes" to get the Bavi pipeline in motion with as least amount of money as possible..but
Yes... we have to play with the big boys in the major leagues to get the Bavi pipeline started so we have to "do what it takes"...
Is everyone listening... ARNA has peanuts to what we will have and sits at 217M shares OS
Outstanding shares is not an issue
http://investing.money.msn.com/investments/stock-balance-sheet/?stmtView=Qtr&symbol=arna
very valid point... ARNA is one of a few up and coming biotechs and their sales revenue don't even compare with the sales revenue of a Bavi pipeline.
Sales at ARNA for 2007= 19.3M 2008= 9.8M 2009=10.3M 2010=16.6M 2011=12.7M
Their current OS stands at 139M shares.... and they "no way" can compare to the future sales revenue of Bavi which if approved will be starting with a B... Billions... not M Millions.
http://www.marketwatch.com/investing/stock/ARNA/financials
I didn't want to put it that blatantly.... but you are right.
OK... we are all here sitting soo close to a Bavi pipeline that will be the cornerstone for any major BP! The profits are drying up for the BP's and Bavi is on the verge to being FDA ready ... along with Avid that has a solid revenues in store and exanding... and an Imaging pipeline which has been shown to gain the interest of Genentech... and top it all off with a phase III ready Cotara.
Bavi being the cornerstone we are on the verge of making some BP major Billions of dollars per year for quite a long time!
Take a step back... think logically about if you have any type of product, service... or drug that could be the "SOC" for all... and down the road a daily/weekly/monthly dose of Bavi may not be out of the realm of possibility. What will the investment portion take?? You telling me that 300M ... 500M... 1B or 1.3B ??? is not worth having a product that will make many multiples of our initial investment.
Many ... many ... many other biotech stocks make it big with outstanding shares larger than our current 132M OS count.
You do what it takes... to get it done and we may not be privy to all the information that King and company holds at it fingertips at this point....
maybe this is a pure power play move to show the BP's that we would go it alone without a partner???
maybe the BP's are ticked off they are forced to play ball with Peregrine and to pay such a large amount of upfront money ... ??
maybe King tells some BP they can be sold ATM shares now ... and with the large upfront money.... it turns out to be a wash once the stock rockets northward after Partnership announcement... therefore that BP makes a profit from their ATM shares...
there is much behind the scenes that is going on... and as long as the science works you do what it takes to get the job done.
If that means 100M or 130M .. or 150M... or 175M outstanding shares? So be it....
Good find sunstar! More dots are being tossed out there.... and when the time is right they will all be connected. Partnership will be coming for Cotara.... for Imaging.... for Bavi.... and Avid will continue to increase revenues and can 2013 be the year of profitability?
I think so
Great post FTM! Peregrine and FDA will be heard often in 2013!!
This is a site of importance because I do believe Peregrine will play a role in this new "breakthrough" drug classification if we have not already been working with the FDA via Garnick.
Its one of the possible reasons why we have soo many Bavi trials in play and ready to submit as much of the trial data as possible over at once to the FDA.
"Recently we identified the first therapy to receive this special designation. And it likely won’t be long before we have more."
http://blogs.fda.gov/fdavoice/index.php/2012/12/advancing-breakthrough-drug-therapies/
Sunstar ...as you mentioned as well.... the FDA has already found the first company to be part of this and all must be tight lipped just as it is in Tustin right now
Our day will arrive... GLTA!
The max pain of December was said to be about 1.25 ...
now the options for January you have about 9,000 calls for $1.50 or less..... and 12,000 + for 2.50 or more....
My guess is the main pain value is somewhere between 1.50 - 2.50 but then after looking at the chart below....
Otc3.... the link you referred before:
http://www.maximum-pain.com/max-pain.aspx
The yellow bar goes up to about $25,000 and is this meaning the money lost is 25,000 ?
I say this month Jan or Feb.... can throw this chart off some.... since a couple pieces of good news can send us north of $5 immediately
I was just testing to see if those selling into the 100's at a time were reading this IHUB board lol ..... now we know we are keeping our enemies closer than we think : )
I'm not concerned.... these are the games that are played while the real news is brewing in Tustin
That job posting should be reposted tonight with perfect spelling : )
Do not fear.... we will certainly see $117 before we see thru $1.17 ever again
Lots of resistance being played with here in my opinion
do I sense a little break out about to happen.... Any time I see DD back on the board its only for one reason
Events to look forward to...
Jan 29 A.J Leyco (Assoc.Dir./Clinical Affairs)
This event just may be the one to finally clear all issues:
"2:00pm: , Panel: "Examining mistakes some vendors make when approaching new clients to build & strengthen outsourcing partnerships" .... could this be the polite way to stress the importance of some new type of standards that need to be used and hopefully showing what went wrong with some "coding issues"...?
http://www.arena-international.com/poutwestcoast
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Jan 31 Bruce Freimark (PPHM's Dir./ProdDEV) to present PS-Imaging at "EMIT: Targeted Radiotherapy Conf." in Wash DC
Then one of our hirings... duties include: "Develops strategic clinical approaches for the overall clinical development of a biotechnology or pharmaceutical product or device, domestically and/or internationally..." and could this be associated with a patent filing for their imaging device/product ? but it could surely stress the importance of using their imaging pipeline for all cancers
11:00am: "Novel Development of PET Imaging Conjugates Targeting the Tumor Vasculature to Improve Understanding of Therapeutic Effect"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79780132
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Feb 4: "SPIE BIOS Photonics West", SanFran
Dr. Philip Thorpe, #8596-3: "Imaging of Tumor Vascular Endothelial Cells in Living Mice [using PGN635=Fh/Bavi]"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=80298325
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"Bachelor degree in life sciences or related medical discipline. 5 years experience in sr. clinial traials manager or as Dirctor of Clinical Operations & Medical Affairs, Project Manager, or Senior Study Manager."
http://www.peregrineinc.com/about-us/careers.html?task=view&id=4
.... ok... how quick does it take to find the misspelled words?
two in a row... "clinial traials" ... then "Dirctor" ???? 3 total! C'mon... and shouldn't sr. be cap'd Sr. ?
Do I dare send an email for misspellings on a job posting...
Loof... How many bottles of Korn Licker did you send them?...Does that Korn Licker have any warnings on the bottle: "Do not update websites while drinking"
New Job Opening: Sr. Clinical Research Manager
"Develops strategic clinical approaches for the overall clinical development of a biotechnology or pharmaceutical product or device, domestically and/or internationally, by performing the following duties personally or through subordinate supervisors."
The mention of "product or device".... gives the feeling of the imaging asset in their pipeline...or any other ideas? will be an interesting 2013!
http://www.peregrineinc.com/about-us/careers.html?task=view&id=4
1) Assoc. Scientist -
2) CMC Regulatory Affairs Senior Specialist-
3) Medical Writer or Sr. Medical Writer-
4) Sr. Clinical Research Manager
5) Technical Writer
http://www.peregrineinc.com/about-us/careers.html
------------------------------------------------
A Holiday Cheer:
Of Mice And Men
Xmas comes all but once a year
A time meant for family, friends and cheer
As snowflakes fall freely in the cold frigid air
The children wait.... sensing Santa is near
Presents are expected but lets stop right there
Traditions of giving must not be lost
Especially for those who buy with no care of cost
Family and friends.. soo close yet soo far away
A simple hello and a phone call today
Is all it takes to bring a smile upon their day
Now lets turn … turn the page
Lets not forget how recent was the rage
A stock from $5 falls below
Everyone wonders… who’s running this show
Could it be The King… or The Street
Or some other form of Cheat
Lawsuits arise and bring some heat
Everyone sit down and hold your seat
Return to the basics of who started this future treat:
All seemed quiet through the house
Can you see and hear… there, behind the couch
But there it is again… a squeech from a mouse
There he lives… a block of cheese and a beer
Old memories of Dr. Thorpe at his rear
now healthy in form and absolutely no fear
As he has lived to tell of those Bavi years
Poked and chased in that small cage
Brought back memories of mice rage
Yet days became months and months became years
Now living longer than all his peers
An immune system was allowed to work in full gear
Jerry’s his name and many reasons to cheer
Life he has………. but a mouse with no shares!
Happy Holidays to everyone!
According to Jerry… Peregrine Shares are still on sale for a limited time only! : )
well its the final day for options... I figured I'd see more volatility one way or the other unless they are saving that swing up for all those april calls.
I am not too familiar with the inner working games but someone did say that around 1.25 would make the payout the cheapest... if I am understanding it right?
If I do understand it right... the amount of capital it would take to force the price of a stock one way or the other to make the #'s work out for the controller of these options would ultimately go to the stock that would benefit them the most.
In other words.... if there are 100 stocks with large option positions and Peregrine happens to have a large # of options but there are 20 other stocks that is more worth while for this controller group to push extra capital at to move a stock for them to reduce their payout then Peregrine may or may not even be involved in their games.
Thanks CP... I think for a confidential filing that I thought there would be something more revealing....like Bavi was indeed being used within coldfusion experiments : )
There are still some COT's under lock and key....so maybe there is something more revealing with Bavi's use.....and as for now:
I will still have to believe that IMHO...Bavi remains the best drug of choice that can be used to help cancer patients allow their own immune systems in stopping the spread of many cancers.
Now the question is was this part of Avids "deposit" money that have received for future orders... as being part of that 30M in orders for the next 2 years?
Avid has certainly turned out to be another key strategic move made by King....and lets go Bavi!
Peregrine just may be the first major BP partnership of 2013! : )
Bavi is the offensive line of a football team....they hardly get the credit but required to block and flip the opposing team back away for the quarterback to function properly. The common cold is to a backyard football game where the Bavi offensive line is not required but the more extreme cancerous cells require Bavi in the NFL to compete and win (live) longterm. If no Bavi in the NFL you end up with SOC record such as 6-10. With Bavi....you can average 12-4.....thats double the SOC record!
GLTA! .....Just trying to give some form of example....and how many people give the MVP to an offensive lineman? ... Bavi simply brings our immune system back to basics because without this offensive line for cancer....... we will never compete in the NFL
I think you answered your own question on your previous post: as for the hiring... could be related to Cotara filing global applications for phase III... maybe a surprise "breakthru" application.... just have to keep moving forward and good things will happen
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79834857
I don't think you should be confused any longer.... patience may be needed for a couple more months though : )
GLTA!
CTO (Confidential Treatment Order) Update:
someone mentioned earlier about "top secret" .. lol and it brought me back thinking about these CTO's that were filed and sealed but there are a couple here with dates that they should be unsealed.... couldn't find anything though .... anyone familiar with the couple (#1 and #4) that were unsealed and what the exhibits consisted of ?
CTO's are filed with the SEC and confidential treatment are awarded if its likely to cause substantial harm to its competitive position.
My only guess is some exhibits in here if found out by major BP's too early into the Bavi advancement could cause hard to Peregrines competitive advantage ... but can't find a couple of the ones that are supposed to be unsealed already?
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#1 filed: Dec 30, 2010
Exhibit 4.15 sealed thru July 14, 2011
http://files.shareholder.com/downloads/PPHM/1969635875x0xS9999999997-10-20894/704562/filing.pdf
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#2 filed: Oct 26, 2010
Exhibit 10.26 both sealed thru Sept 9, 2013
Exhibit 10.27
http://files.shareholder.com/downloads/PPHM/1969635875x0xS9999999997-10-19095/704562/filing.pdf
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#3 filed: May 28, 2010
Exhibit 10.17 all sealed thru April 15, 2013
Exhibit 10.18
Exhibit 10.19
Exhibit 10.20
Exhibit 10.21
Exhibit 10.22
Exhibit 10.23
Exhibit 10.24
http://files.shareholder.com/downloads/PPHM/1969635875x0xS9999999997-10-12220/704562/filing.pdf
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#4 filed: July 20, 2009
Exhibit 10.111 sealed thru March 12, 2012
http://files.shareholder.com/downloads/PPHM/1969635875x0xS9999999997-09-22701/704562/filing.pdf
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#5 filed: Sept 30, 2008
Exhibit 10.110 sealed thru June 30, 2013
http://files.shareholder.com/downloads/PPHM/1969635875x0xS9999999997-08-41082/704562/filing.pdf
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Update Job Openings: CMC Regulatory Affairs Sr Specialist latest addition... and Sr. Research Associate was taken down
Not sure how many here have looked much at LinkedIn..... it may be helpful since most employees update their pages to include "peregrine.." as their new employer and you can see what BP Peregrine was able to recruit them from since Peregrine is only going to give us that info for top of the food chain employees only.
Hoping for some news in the a.m.! : )
http://www.peregrineinc.com/about-us/careers.html?task=view&id=50
#2 CMC Regulatory Affairs the latest job posting
#4 Sr. Research Associate was taken down/filled
1) Assoc. Scientist -
2) CMC Regulatory Affairs Senior Specialist-
3) Medical Writer or Sr. Medical Writer-
4) Sr. Research Associate, Analytical Biochemistry
5) Technical Writer
http://www.peregrineinc.com/about-us/careers.html
------------------------------------------------
New Job Opening: CMC Regulatory Affairs Sr Specialist
"....assists in the implementation of global regulatory strategies and timely preparation of global regulatory submissions.
...Experience with planning, preparing and successfully filing INDs, BLAs, or NDAs. Direct CMC experience with biologics required."
much more lots of goodies in store.... mark my words here, this next hiring will and should gathers lots of attention because they should be able to attract much... much... mucho much talent from the biotech field! : )
http://www.peregrineinc.com/about-us/careers.html?task=view&id=50
at time of viewing... 5 jobs total listed:
#2 CMC Regulatory Affairs the latest job posting
1) Assoc. Scientist -
2) CMC Regulatory Affairs Senior Specialist-
3) Medical Writer or Sr. Medical Writer-
4) Sr. Research Associate, Analytical Biochemistry
5) Technical Writer
http://www.peregrineinc.com/about-us/careers.html
"One of the most financially successful cancer drugs in the world appears to cause more fatal side effects than previously realized, a new study says. Avastin, a blockbuster drug with more than $5.5 billion in global sales, increases the rate of fatal side effects by almost 50% when added to traditional chemotherapy, compared with chemo alone."
http://usatoday30.usatoday.com/news/health/medical/health/medical/cancer/story/2011/02/-Avastin-increases-fatal-side-effects-in-cancer-patients-study-shows/43156628/1
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NSCLC Trials and Troubles...
just started to look at some of this years NSCLC trial failures and its interesting to look at their Phase II vs Peregrines Ph II's in how I couldn't seem to find many doing such a "gold standard" trial as Garnick had set forth which is further proof in how confident Peregrine is in the final results when they hopefully come in soon ...
Dec 19, 2012
Merck announced today that the Phase III START(a) trial of its investigational product L-BLP25 (formerly referred to as Stimuvax®) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS).
http://www.merckgroup.com/en/media/extNewsDetail.html?newsId=EB4A46A2AC4A52E7C1257AD9001F3186&newsType=1
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Oct 2, 2012 ARQL - ArQule based in Woburn, MA
"The partners have stopped a major Phase III study early after a data monitoring committee saw no hope for the study to meet its primary goal for improving overall survival."
.... tested a combination of its ARQ 197 and Roche's $RHHBY) approved Tarceva (erlotinib) against Tarceva and placebo."
http://www.fiercebiotech.com/story/arqule-shares-nosedive-failure-key-phiii-trial-lung-cancer-drug/2012-10-02
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Aug 6, 2012 Agennix based in Germany & Princeton, NJ
"Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the FORTIS-M Phase III trial with talactoferrin alfa (talactoferrin) did not meet its primary endpoint of improving overall survival. The FORTIS-M trial evaluated talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer (NSCLC) whose disease had progressed following two or more prior treatment regimens. Median overall survival in the talactoferrin arm was 7.5 months compared to 7.7 months for placebo (hazard ratio 1.04, p-value 0.66)."
http://agennix.com/index.php?option=com_content&view=article&id=227%3Aagennix-reports-results-of-fortis-m-phase-iii-trial-with-talactoferrin-alfa-in-non-small-cell-lung-cancer&catid=23%3Apress-releases-2012&Itemid=56&lang=en
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Pending:
Lucanix: Started May 8, 2008 & Completion June 2012
http://clinicaltrials.gov/ct2/show/record/NCT00676507
Dr. West below has opinion that results will not be as good as their Phase II
" I think we really need to see whether these very provocative results in a few dozen patients who may well not be representative of a broader general population of advanced NSCLC really hold up in a proper randomized clinical trial. I agree that these results are hard to believe, which is why I’m not sure I believe that anything remotely like these results will be replicated in a larger and more controlled trial setting.
Also, bear in mind that the phase III Lucanix trial has been accruing for a long time — years now — and I have to imagine that if the results of that larger trial looked anything close to as promising as the phase II, the Data and Safety Monitoring Board would have seen a startling difference part-way through the trial that would have compelled them to close the trial early and publicize the result. The fact that this hasn’t happened despite the fact that the trial has been accruing for several years makes me very, very suspicious that we will NOT see a recapitulation of the phase II results on a larger scale in the phase III study."
-Dr. West
http://cancergrace.org/lung/topic/lucanix-results/
will add to this later... or feel free to add anything
NSCLC trials... just started to look at some of this years NSCLC trial failures and its interesting to look at their Phase II vs Peregrines Ph II's in how I couldn't seem to find many doing such a "gold standard" trial as Garnick had set forth which is further proof in how confident Peregrine is in the final results when they hopefully come in soon ...
Dec 19, 2012
Merck announced today that the Phase III START(a) trial of its investigational product L-BLP25 (formerly referred to as Stimuvax®) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS).
http://www.merckgroup.com/en/media/extNewsDetail.html?newsId=EB4A46A2AC4A52E7C1257AD9001F3186&newsType=1
----------------------------------------------
Oct 2, 2012 ARQL - ArQule based in Woburn, MA
"The partners have stopped a major Phase III study early after a data monitoring committee saw no hope for the study to meet its primary goal for improving overall survival."
.... tested a combination of its ARQ 197 and Roche's ($RHHBY) approved Tarceva (erlotinib) against Tarceva and placebo."
http://www.fiercebiotech.com/story/arqule-shares-nosedive-failure-key-phiii-trial-lung-cancer-drug/2012-10-02
-------------------------------------------------------
Aug 6, 2012 Agennix based in Germany & Princeton, NJ
"Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the FORTIS-M Phase III trial with talactoferrin alfa (talactoferrin) did not meet its primary endpoint of improving overall survival. The FORTIS-M trial evaluated talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer (NSCLC) whose disease had progressed following two or more prior treatment regimens. Median overall survival in the talactoferrin arm was 7.5 months compared to 7.7 months for placebo (hazard ratio 1.04, p-value 0.66)."
http://agennix.com/index.php?option=com_content&view=article&id=227%3Aagennix-reports-results-of-fortis-m-phase-iii-trial-with-talactoferrin-alfa-in-non-small-cell-lung-cancer&catid=23%3Apress-releases-2012&Itemid=56&lang=en
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will add to this later... or feel free to add anything
" The fact that several potential competitors are failing in their NSCLC trials IMO increases the mathematical probability that PPHM will ultimately find a suitable partner for their drug in this indication (or platform in general)."
I agree RRdog..... and partner by this spring/summer would be good!
They may be working thru the issues internally...and agreed not to further place blame on the 3rd party if they can work things out. Sometimes lawsuits just further complicate matters if its just a "coding issue".
I would compare this to a fender bender and keeping the insurance out of the matter and the two parties resolve the matter and move on.
Peregrine is telling us since it went from "major discrepancies".... to "internal review"....that the frame (trial) has not been damaged and the car (trial) is indeed salvageable!
Since it also just happened to help the stock options....$1.21 !! ....Management is not complaining.....CRO not going to complain as no lawsuit....and shareholders and patients will not be complaining if Peregrine delivers the doubling of MOS in the coming month.
FTM...again, great post!! This clearly should show everyone how amazing our results have been for Bavi. More importantly....has anyone else jumped into soo many trials as Bavi is included in.....? No way..!
Further.....all this is clearly seen immediately with the medical specialists that the future partner of Bavi has engaged in talks .... and will advance the talks positively for Peregrine.
All in my opinion.....and as more dots are being connected....the volume will follow....and share price will catch up quickly.
GLTA!
"The company, based in Darmstadt, says the drug Stimuvax did not improve the overall survival of patients in the phase III study."
... I'm sure they will provide the "actual" numbers on a friday... and its looking good for Peregrine as they currently still have not reached "MOS" on all three trials 1st/2nd line NSCLC and Pancreatic
Peregrine gains leverage the longer the "MOS" is extended ... and the longer a partner does not come up with a fair offer for Peregrine