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At this point in time there are literally thousands of people who would know the truth about OS benefits and Bavi, if it was in fact true. The stock would only be sitting here at 80 cents if in fact there were no OS benefits.
Simple logic really but you boys just keep dreaming.
Well, I can see still no one here interest in how it can possibly be that 5 months go by and nobody notices improper coding.
Well, okay, I can see that none of you are interesting in accumulating a knowledge base on anything occurring prior to Sept 7th...Nothing that might lead to the possibility of misconduct during those 5 months of "careful" study. That tells me that Cloak and most of you people are here only to assure that King & Co. never get pressured.
Regards,
C
Thorpe and Gerber would want to see all those scans and blood work during those 5 months between May and Sept 7th. They wouldn't possibly tout Bavi without that basic backup, right?
The Investigator should provide a copy of the protocol to the manufacturer (e.g., contract manufacturer) of the investigational product for ascertaining the final configuration (content, packaging) of the investigational product. The description includes but is not limited to:
The number of subjects on each type of drug/device
The dosing schedule
Randomization code, if necessary
A description of the size, type and components of subject kits
Package sterility requirements
http://www.jefferson.edu/human_research/sop/PM-502.cfm
7.2 Un-blinding should not take place until the database has been locked i.e. all data
entered, validated and no further changes are expected.
7.3 Furthermore, it is best practice for the person performing the statistical analysis
to remain blinded until after the analysis has been completed.
http://nuhrise.org/wp-content/uploads/SOP-9-Unblinding-Procedures-for-NUH-Sponsored-IMP-Clinical-Trials-v4.pdf
KT, couldn't agree more. We need that information. And there's also this:
4.6.2 Where allowed/required, the investigator/institution may/should assign some or all of the investigator’s/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution..
http://ichgcp.net/46-investigational-products
Once the investigational product is at the site, as monitors we can review expiration dates and inspect the product regularly and document the inspection in our reports. We need to check that everything that was supposed to be used is not present (counting the used IP and reconciling our counts against the tracking documentation), and also that everything that is supposed to be intact has not been used. We can also physically check that blinding envelopes plus unused investigational product foils and seals are intact and have not been tampered with. We will review the temperature logs to record and report any temperature excursions. We will also verify that there is restricted access to the investigational product; controlled with double lock and key. Finally, we can review the schedule of planned activities at the site and ensure there is adequate supply of investigational product to support continued research efforts. We will record any deviations or discrepancies and report to the study team and retrain the study personnel as appropriate.
Repeating the accountability exercise at every visit can be a time consuming process. If it isn’t stated in your study monitoring plan, ask your Project Lead if interim return/destruction of the used/expired investigational product is permitted. This is certainly advantageous to waiting until the end of a long study and then trying to reconcile all the paperwork and re-count everything
http://leadcra.blogspot.com/2010/06/investigational-product-accountability.html
Yes, and I guess it doesn't matter to know if some mid-level idiot could have botched or sabotaged the trial from the get go. Or that with all trials nobody ever checks this kind of thing up front so as not to waste two f'ing damn years! Or that we may or may not have engaged a statistician to assure the trial was set up properly. Or that Garnick or whoever was that person. No, none of that is important except for your silly 13D's. Really!
Thanks for that link. Every little bit helps.
An Alarming Two Thirds of All Scientific Publications and Research Retracted Found to Be Fraudulen
http://www.theglobalistreport.com/publications-research-articles-retracted-fraud/
Loof, It seems management does just fine creating doubt without me trying to do it for them. I'm holding my shares but my only intention now is to get to the bottom who's responsible for what so that if (only if) they did something underhanded they get caught. I've been through too many of these bio-blowups to know that most of the poster's, management, and analyst will not be around very much longer, they'll just fade into thin air and we'll never get the story straight. It seems like AF and others have lost interest already and that's no a good sign, imo; Management's silence is not a good sign, imo; People posting positive fake articles (Forbes) is not a good sign, imo; And poster's not interested in justice is not a good sign, imo.
The article in question is talking about missing data and appears to be very relevant. Coding is a sophisticated process. Wouldn't you like to know what was going on during those five months? Or how long it actually takes to evaluate 90+ patients? If they used a statistician or decided to do it on the cheap and go it alone? Who developed the code and checked incoming product? And mostly don't you want to know if you got ripped off? Because to the best of my knowledge there is no investigation that's going to answer that one simple question...There rarely is these days.
Yeah, that's right, Loof, leave it to the real fellers...whoever you think they are. Ridiculous. If I recall you bailed and someone talked you into staying. Well, I'm still here and nobody had to convince me to stay. But I do want answers! And from what I've seen this board is doing a better job than any law firm will ever do for shareholders. We need answers NOW! And not when management scatters -If they do that is. I fully admit to not having the answers but I've been known to have some pretty good questions.
So again, let's think about coding procedure and dig up whatever we can on it. If I really got robbed here I want to know by whom.
http://www.ivillage.com/missing-data-may-skew-clinical-trials/4-a-491783
Good revision. Now let's figure out what occurred between May and Sept 7th. I have to believe that a recheck of code construction is standard and done before the trial begins and at least once along the way. No way a trial goes 2 years without many checks on coding, right? Are we all in agreement? And at the beginning of analysis by the statistician/s, it has to be done then too, I suspect.
You know the old saying "Time heals all wounds". Let's hope this is not a tactic by management.
This from 2009: Based on what we know now about the ATM would you say this IR statement was a lie?
As far as we know, Peregrine management is not selling shares on the open market. Peregrine as a corporation does have an an-at-the market offering in place, where shares are sold into the market to raise capital if market conditions are favorable. The goal of this at the market offering is to raise money to fund Peregrine's clinical trials, which management believes will be the most important value-driver for the company and for shareholders. However, as noted, this program is only activated when market conditions are favorable, and is not activated when they are not.
Peregrine management is committed to creating and preserving shareholder value, and therefore would not advocate selling shares into the market when market conditions are unfavorable.
Thank you for your support of Peregrine.
FiduciaryDoozy over there is suspect of the company's claim of 170+ employees. Are we all in agreement that these people actually exist? Has anyone actually been to Tustin and seen the operation in full swing? And just what is they'd all be doing?
We never really even knew if Garnick was an employee or consultant. If Garnick goes we'll never get any official word, imo.
This board is really amazing. It bothers me that some of you with so much knowledge and reasoning could be working the dark side. What a waste that would be. Anyway, I'll assume the best for now.
I know many of you have a lot more invested than I do. Should this escapade go further south I sincerely hope you've all pooled resources together and have a good attorney waiting in the wings. Because you know they'll be all lawyered up.
Is the King being airlifted out?
Yes, that's very telling, Cloak. You are on my watch list.
But I tell you the idea that the data debacle somehow all just came together and coincidently landed a Monday before the bell-lockout-release seems, to me, beyond the odds.
I continue to think the worst of "Management".
Cloak, Selling ATM shares when they knew they had corrupt data is somehow okay? Who would blame them? Really! I just lost respect for you. If they did do that to unsuspecting investors then they belong in jail, period!
Cloaked, really excellent post. Wow! Thank you.
I continue to have issues with letting 4 months go by before the data is realized to have major discrepancies . Can you shed anymore light on a possible reason so much time elapsed? To me it seems inapropriate to excuse them for only getting to it for an FDA review. What about their shareholders?
Think about what occurred during those 4 months and the lack of consideration for shareholders by not reviewing. And combined with the grand finale in Chicago and $5 marginable share price action. If this were any other management team I'd probably be with you 100%. I continue to be suspicious.
And hypothetically, what if this trial turns out to be a complete loss and we see King resign. If I may ask, what would your opinion be then? And no. I'm not trying to stir anything up beyond preparing for the worst.
Thanks again.
When did Peregrine discover this, why so late?
Peregrine discovered this on and about SEPT 20, 2012 as they claim in their lawsuit filing. The data was unblinded in MAY 2012, so 3 to 4 months after unblinding. The holiday season and the fact that reviewing clinical trial data is a hard job and needs a lot of time are certainly the major causes. Peregrine was, by FDA test standards, not allowed any involvement or data access during the clinical trial and could therefore not be aware of these discrepancies any earlier. It therefor only discovered them during review, part of the course of preparing for an end-of-phase II meeting with regulatory authorities (FDA).
That reasoning seems solid enough. So...if they do not advance to PIII then we know with good certainty that there never was a BP in the wings and King is a sham.
Good thoughts. Wouldn't it possible to sample the blood of all those with increased survival to find some trace of Bavi? After all it's only some 90 patients.
At least 5 days "management" knew about bad data and shareholders did not. And this after 6 months of having access to the data.
Low institutional holdings and no BP on board at the time of the great MOS announcement are good clues something is not right.
Bank recalling the loan on a dime is another good clue.
Access to their calendar would tell us if they ever had any "high level" BP meetings.
An audit of employees is in order.
So nobody addresses that they had 6 months to check third party figures? Or why it takes all this time to review 90 patients? Or if it's a given that other biotech's and BP actually check 3rd party data in a timely fashion.
Did you ever think while your sitting here waiting for a press release they are all quietly exiting. I think at this point that's a real possibility. Zero support for shareholders and a fiduciary breach, imo.
I sure hope you people are up to the task but judging by the post I'm not so sure.
No clue why it matters? 6 months and "management" never thinks to verify 3rd party suppliers number knowing that they're going into Chicago and "in talks" with BP? Do other biotech and BP check and recheck 3rd party data? Doesn't make sense. And then there's this:
4.7.2 V 1.2 Page 3 of 9
Unblinding – Unblinding is the process by which the allocation code is broken
so that the investigator, clinical staff and/or the trial statistician becomes
PaCCSC SOPs February 2008
©2008
aware of the intervention for a person participating in a trial. The usual reason
for unblinding in a study context is that a person participating in the study has
encountered an urgent medical problem necessitating that the clinician know
his/her intervention allocation. People are not unblinded at the end of their
participation in the study.
Unblinding envelopes – A series of envelopes, each labelled with the
randomisation number that contain the allocation for that person. These
envelopes are sealed by the central randomisation service, and are only
opened if emergency unblinding is required.
http://www.caresearch.com.au/Caresearch/Portals/0/Documents/WhatisPalliativeCare/NationalProgram/PaCCSC/4.7.2Unblinding.pdf
What's that gotta do with anything? I'm asking you all for some simple help - When was the study unblinded? And please provide something concrete from a pr or anything but your speculation. Thank you.
Yes, that's all they have...And all this for maybe 90 trial patients. The idea that it would take them more than a few days to unscramble all this is simply ridiculous. Not one poster here has provided me with any accurate information regarding the unblinding of the PII trial. I say it was 6 months ago and AF says 9 months ago. Amazing how most of these poster's dish out only the information you want to hear -Not all though.
"Nasty dip"? Really! You are much more likely to see the patented Peregrine move of lower volume going under a million a day accompanied by "management's" compete silence. Nothing is worse for long time shareholders than inactivity. I'm betting you will see it because that's "management's" way.
This entire event brings into question the reliability of all third party work for biotech and Big Pharma.
You should write the FDA pronto and question their 3rd party approval process and demand that all BP go back and check coding of drugs currently on the market.
Do you understand what I'm saying people?
I want you all know that I really do believe in Bavi...just not in "management". I think the drug has a real mechanism of action and it's just a matter of finding the right timing, dosage, and coupling. Perhaps during the trial they stumbled onto something.
That said, and besides the possibility of outright fraud (Still very good possibility, imo), I think it's highly likely that "management" works for BP with the idea of doing all the upfront work on the shareholders tab.
Possible evidence:
Incestuous Board consisting of lawyers and financiers.
Track record of crushing shareholders but not insiders.
Employees that appear to move around or part time.
Government contracts that never amount to anything.
University's choice to remain with an unknown quantity (given Bavi's potential I find this odd).
Evidence that King has never really been in talks with other BP (not one meeting over ten years ever materialized into a thing)
This recent debacle would provide BP with a great opportunity to take over the IP without paying for it.
This is a possibility, I have to admit.
I will give you that. But then there is cost consideration and what a broke government is willing to pay for.
Well let's see, maybe it's the difference between an oral vs. drilling a hole in your head. Hmm.
Loof, Pretty funny, right? You're funny too! Always need a laugh...Probably as effective as Bavi. The Boyd crack is always a winner with the crowd.
But do be careful because me and FiduciaryDoozy have a fairly good track record.
I don't know why the board deleted this. I was just making a comment that if "management' really cared about it's shareholders it would implement something like this:
Corporation (GERN) today announced the appointment of Susan M. Molineaux, Ph.D., and Daniel M. Bradbury to its board of directors. Dr. Molineaux is joining the board`s nominating and corporate governance committee and Mr. Bradbury is joining the board`s audit committee.
"In making these two appointments, we are adding important skill sets to our board of directors," said John A. Scarlett, M.D., Geron`s President and Chief Executive Officer. "Dr. Molineaux has substantial experience as an oncology drug developer, with an emphasis on translating cutting edge biology into clinically relevant drugs. Mr. Bradbury brings extensive leadership experience from a highly successful commercial biopharmaceutical company. We welcome Susan and Dan to our board of directors and look forward to their contribution as we drive our oncology development programs forward."
Yes that is puzzling. But then again had investors known the ATM was in full swing it would've never made it to the high water mark of $5. Just the idea of the loan bolstered investor confidence, as did the annual meeting at headquarters. Hard to say which came first but looking at "management's" history, they appear to always find ways to bolster investor confidence. It just never pans out that's all.
A peek into one possible future:
"Management" will continue their silence until the stock is in the .30's.
Bankers throw party and celebrate another great caper.
"Management" will announce news that the PII trial is not salvageable and impossible to decipher and therefore null and void.
Garnick and Gerber will disappear (if they haven't already).
King will resign with nice package.
Lytle will announce that all the other trials have been cancelled due to misconduct issues and they are searching for a new CEO.
University takes back all their IP.
U.S. prosecutor will enter the scene
Johnson & CO. will bill the company for legal defense while Lytle raises money through ATM using the new imaging technique as the companies next catalyst.
Ms Boyd has hit the ground running and has not been seen from since.
Shareholders find out that no real talks with BP ever actually occurred.
172 employees appears fictitious and raises eyebrows with suing law firms. (The good news is Peregrine's demise does not add to the state unemployment figure).
BOD's and CEO/CFO are at real risk of prosecution
Shan becomes scapegoat and turns.
The rest of my vision is blurry at his point.
• the Study Statistician who is responsible for reporting unblinded analyses
to the Data Safety Monitoring Board (DSMB) and
Who comprised the Data Safety Monitoring Board?
The Data Safety Monitoring Board (DSMB)
o The DSMB will determine that an unmasked analysis is
required.
o The decision will be minuted within the committee meeting
minutes
o A DSMB designee or the study’s Lead Statistician will make
a written request to the lead investigator to instruct for study
unblinding
When was PII unblinded?
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/ct2/show/NCT01138163?term=peregrine&rank=12
Oh, yeah, ok, I'm suppose to believe that. When and only when they pr something is when I'll believe it. Gosh, even that would helped had they put it in the pr. That's why it's probably not true.
"Management" never said weeks not months. Another lie.