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Dia,
I think if you read entdoc's post again you'll find that it implies that pancreatic MOS has been reached. He said that only the former (i.e, the NSCLC trial) hadn't had reached MOS yet. It implied to me that Pancreatic MOS has been reached. Entdoc would you please confirm if you are reading this.
Thanks.
Whoops, forgot that character.
Corporal,
Well, that is quite the endorsement. Wish he was Vanderbilt. Solid focus and ruthlessness; great combination.
Corporal,
So are saying our CEO is a Capt. Parmenter type or a Sgt. O'Rourke type?
CP,
I'm not sure I am interpreting your response correctly but due to lack of commenting on this issue are you saying you don't care and/or have no position on whether management may have fallen down on the job by ensuring appropriate audits were performed prior to contracting with the 3rd party vendors?
Also, I never said or implied it was Peregrine's responsibility to "redesign" anything. An audit is to ensure the vendors have processes, procedures and personnel that will ensure the vendors will perform per industry guidelines (i.e., per the book) and per PPHM needs and requirements. Obviously performing in a manner that caused a coding problem that we have experienced didn't meet Peregrine's needs. It is up to Peregrine to perform audits to help try to prevent these things. It is definitely not considered prudent to rely on regulatory certification only.
Another area of management's responsibility would be to ensure the company had adequate procedures and plans in place themselves to ensure the trial data was vetted accurately, expeditiously and completely including data correlation as you describe (again IF the necessary information was available at the time of unblinding). I still believe too many people are giving a pass on the fact they MAY have had the relevant data in their hands two months before the promotion of the data began. IMO, with the number of patients involved, the time allotted and if in fact there was an excellent plan in place (excellence deserves bonuses) to evaluate and vet the data, then 2 months is more than enough time to have found the problem IMO.
I could very well be out to lunch on this issue, but I don't believe we have anywhere near enough information on this subject and I don't believe the 3rd party vendors handling the data would have caused any delay in Peregrine having data in their hands after unblinding had occurred. Again I don't see how a pass can be given to management on this issue either. Since I've been invested in Peregrine (2004-05 time) I don't ever remember such a huge negative setback issue that had so many significant unknowns that COULD BE laid at the feet of senior management.
Having stated that, I'm still conflicted as to what might have been better overall for the company regarding this screw up. Would it still have been better to get the news out that the treatment arms were doing so much better than the control even if a screw up was in the offing? Detection of the 3rd party screw up prior to the positive treatment arms' news would almost assuredly have guaranteed that that Peregrine would never have been able to to tell the world how well it was working. At that juncture in time our stock price - and the health of the company - may have suffered even more than it has now. We were already getting long into sub 1.00 time periods and we most likely would have been required to get an extension for de-listing and drawing us even deeper into the possibility of a reverse split and we still would have suffered significant credibility issues. At least we got a reset on the de-listing issue.
On the other hand we are now saddled with what may be even larger credibility issues not to mention the overhead of the lawsuits. People can term them baseless all they want, but they will take up very valuable resources of money and senior management's valuable (time they need to continue to learn their lesson with (just joking)), not to mention the impact they have on credibility.
Anyway, IMO, if Peregrine truly was looking out after the long term interests of the company first, they would have been performing the actions that I characterized as prudent and not dreaming that they could have relied less costly approaches that could have involved such things as hiring cheaper less experienced personnel to perform audits or maybe not even performing the audits altogether or maybe deciding to wait until the trial was further along before assigning resources to verify and validate the data provided from the 3rd party vendors after unblinding.
Yes my negatives are conjecture, but it is also conjecture to say that management does not have any significant possible liability in this issue. They may have performed the needed tasks to discover the issue before submitting to the FDA but they didn't perform the needed tasks to discover it before creating a public relations nightmare.
Also, I truly do not believe they need the bonuses for attracting anyone at this time or in the near future. The immediate risk I see is not being able to retain a contractor like Dr. Garnick. From what I have read on this board management personnel are already more than reasonably well compensated for this size company. If a guy like Dr. Garnick truly believes what he's been telling us, he'll stick around and wait for the flack to die down and get the next round of bonuses or if the company really needs his services (which I think we do) then they would work out a deal with him. They could transfer some of their existing options to him if necessary. I'd vote for that.
Its all academic anyway. I'm sure management has the votes to get their agenda passed. I wanted to take the time to make sure they are aware of the growing dissatisfaction because they probably have nothing better to do now because they aren't getting ready for any PIII meeting in the near future. Yes I believe IR reads this website. I think they would be stupid not to.
If you don't mind why don't we end the discussion regarding the bonuses now. I feel like I've discussed it all that I want to and I don't very much like slamming Peregrine publicly anyway. I just thought differently enough on this issue to violate that for once. If you want the last word go ahead.
Take it easy CP.
CP,
Again, I disagree with your support of management.
You state:
crow99,
Nice to meet some others who agree on this issue.
CP,
I respect you and your opinions and am thankful for your input. However, I disagree with your position on awarding options.
First, I don't believe they have any great need to hire in the next few months. We don't have a great need because our big trial is winding down and the whole Bavi PIII is in doubt so I don't see us needing to increase spending in the near future. Options are IMO to attract big time people and not lower level workers who tend to have the higher turn over rates. We have all the big time people we need. If we need money for workers its for the lower level ones that turn over more frequently and voting for options isn't going to help that.
When this issue clears up (or not and we start relying on other trial data) we'll get any money from another financing effort or partnering. No need for shareholders to keep taking it on the chin when the ONLY clear winners will be the senior management team and the workers already there who have had a chance to collect options over the years. All these people may or may not have some responsibility for this latest fiasco. Why would you want to award them now. There is no proven performance indicator to justify it. In fact its quite the opposite. What I see is a ton of money spent and total ambiguity as to whether we can salvage anything out of it or not.
I don't see the most important people walking away because they already have a boatload of options and they were starting to get wealthy there for a short period of time (just as I was too). Its my experience that only senior managers place a lot of significance on option awards because they are the only ones who are granted significant amounts to make it worth considering. Its our senior managers that have some splaining to do.
I think it irresponsible not not hold them accountable for a major fiasco if they will not, and yes even if they cannot (because they led us to this condition), provide information as to why they shouldn't be held accountable
It emboldens them not to improve their processes, self checking and forward thinking to prevent such events in the future. I laid out a fine reason in a previous post why they are not off the hook on this mess by any means and it is obvious that a lot of people have rose colored glasses on to blindly give them a pass now.
Yes I use "blindly" as an insult just like people are insulting with the "moronic" and "doesn't look like the smartest thing to do" and "everyone is entitled to hurt himself" statements. I don't hide it using the smarmy ways employed by the people who don't agree with those of us to try to make a statement that big improvements in communication and management processes need to occur.
Why do we need improvement in these areas? It should be obvious; we are at standstill - as far as the market is concerned we are at a standstill - after having spent tens of millions of dollars on our break out trial and we have had no information for 3 weeks not to mention the loss of the hard fought for and even more difficult to win back credibility factor. We now have to wait for pancreatic cancer trials to get us back on track. Do we even have a history of pancreatic cancer treatments to provide us with a modicum of confidence regarding the possibility of positive results. No. We have to rely on our belief in the MOA of Bavi. I have that faith, that's why I'm still here.
Yes it does give me some satisfaction in sticking it to the uncommunicative senior managers. They should be expecting it if they have half a brain. But hey its business and they have to ask for the options; its their job. Its our job to hold them accountable and say no until this is cleared up and they convince us that they deserve money at the expense of the value of our shares.
I don't know for sure but I'm fairly certain there are means to grant the option awards at a later date with special meetings and votes. Yes it will cost more to hold special meetings and votes but the way the money may have been wasted on this latest trial fiasco, I would say its a drop in the bucket compared to that.
I've given senior management a pass for years because they have always progressed. Now they haven't (big time stoppage and ambiguity here). Let's not even get into the failure to progress with Cotara. I never really gave much of a hoot about Cotara with the Bavi trials progressing the way they seemed to be but they (senior management) should have; its their job. It would certainly have been a good contingency by this time to have progressed that to PIII.
Some people can only see it as being vindictive. I see at as holding them accountable. I know the 3rd party screwed up and caused this problem.
However, there have been several areas of possible poor management oversight proposed on this board that could have helped avoid creating an unsubstantiated promotion of bavituximab's performance in 2nd line NSCLC and the subsequent loss of credibility.
I still believe in Bavi or I would have sold on 9-25. However, that doesn't mean management is off the hook.
If truly, they had the data available to them since un-blinding in May to allow them to detect this coding error sooner then shame on them for not being pro-active in assessing the data in the most important trial of this company's history.
I see that as bad management IF that occurred. Why don't I know if that occurred? Because we have had zero information provided. When someone doesn't provide information like that its usually because it will look bad.
It would have been very easy to say that the data to determine the coding error was only recently obtained but they chose not to. I think management has culpability here and I choose not to award them or any of the the people (top brass, department managers supervisors and workers who were responsible for reviewing the data) until I am convinced they weren't culpable.
They can and should put off the granting of awards until they prove they weren't responsible for a significant lack of oversight on their end.
I would gladly support a special meeting to grant retroactive cheap option awards (if that is even legal and if not balance it with more options to offset) when they provide evidence they deserve it.
So you also mean "perhaps with basis"?
Thank you ex for your take on this. I'm concerned that we appear to be supporting competition to one of our chosen avenues to access a major market for our products. I guess one can look at it as creating a greater potential to gain access to those imaging markets but at the price of having to share the wealth (i.e., we make less and the pipeline is worth less). I would have preferred that the PPHM patent portfolio would have locked up tight the use of our intellectual property mabs with any type of radionuclide for use in imaging. It may be that way but it doesn't look like it if there are other companies doing research with our mab and their choice of radionuclide and no announcement of any deals regarding this use.
However, I prefer to now look at it (after receiving FTM's info on the crediting of Thorpe and Peregrine)as a deal in the works between Genentech and Peregrine and that Genentech is performing some research on the scope of the imaging potential and to get a head start on locking up different avenues of the imaging property rights.
Only time will tell.
Thanks again FTM.
Thanks FTM. I'm just wondering here. I'm not a patent expert by any means and it just seems suspicious that a company like Genetech would expend the resources for such research if they didn't have guaranteed access to, and guaranteed monetary benefit from, the materials being researched.
FTM or Entdoc or other medical pros and Patent Attorneys that may be here,
Does anyone know if there is a benefit using I vs. Zr in these imaging trials? Can the labeling using Zr be a basis for creating their own patent for imaging and shutting out Peregrine?
Thanks.
http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/50/2_MeetingAbstracts/497
http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/50/2_MeetingAbstracts/203
Stone,
I will be voting the same as you if there is no update on the 2nd line NSCLC trial fiasco by close of business tomorrow.
PW,
Thank you for the great effort you made to provide us with factual information. It is much appreciated.
You have no proof of the following:
LearningDisabled,
You are absolutely full of misinformation.
Bungler,
Thank you for that info. That will stop a lot of unfruitful conjecture in its tracks.
RCJ,
I too thought CSM had responsibility for coding and distribution for the entire trial. That's why I'm confused about the article's statement that they were doing the coding and distribution for one of 3 trials. Still don't understand. I think its as simple as the article made a mistake but don't know.
As a side note I'm watching the Fugitive in my hotel room in Mass. right now. How appropriate I'm watching a movie about Pharmaceutical intrigue involving espionage and murder to protect a BP's drug line.
RCJ,
Thanks for the reply. I don't remember hearing this angle before; where there are 2 or more companies handling the coding and distribution for the 3 different geographic areas where the trial was being conducted. Are you absolutely sure about this? I really have been avoiding reading all the posts last week because of the noise and I've been on the road for the past week and if this was covered before I'm not in the loop.
If true then the CSM coding screw could only have affected the half of the trial patients in the US. Is this also correct?
Thanks RCJ
CJ,
Thank you too for the great info you provided today. You continue to be an anchor point for great info.
Regarding the article's statement that CSM provided services for one of 3 double blind, placebo controlled studies of bavituximab; was that a misprint/mistake? I thought that the 2nd line NSCLC trial was the ONLY double blind, placebo controlled bavituximab trial ever done or currently being done. What am I missing? What are the other two double blind, placebo controlled trials? It would be great to have 2 other double, blind trials going on but I don't think they exist and I think the article was incorrect in this statement.
bimerkjaere,
Let me be the first to thank you for this information and the effort. It is much appreciated.
Thank You!
I don't know.
Carboat,
Re: your statement of "But hypothetically if all of the censored were deceased very early (unlikely)...";
Why would it be unlikely? 2nd line NSCLC, and 90% stage 4, with the knowledge that this disease is one of the very worst and has on of the very shortest survival prognosis going. I would expect a trial for this disease and this composition of 2nd line and 90% stage 4 to have a high percentage of censored patients due to early death. As I understand it people are usually all out of options when they get into trials like this and its late in the game for them. It would be good to see a comparable trial's censored data to get a feel for this issue.
Vogat,
Multiple Mega Dittos on that!
Bungler,
I wholeheartedly agree with that assessment and I tried to state that (with reservations as noted) at the end of my long winded post. That is the BIG reason that I didn't sell this week.
Volgat,
I certainly hope that is the case; believe me I certainly have a lot riding on it. However, I still feel that the sentence info you have bolded can be read a different way.
I can read it as [...some "patient sample test results"...] not as [..."some of the patients had sample test results that had discrepancies"...]
I know for a fact after reading the following link (which doesn't seem to be working for me anymore but luckily I downloaded it to have a copy):
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2191&EncHid=&userName=bavituximab
that there are multiple types of samples taken from the patients during the course of the trials and these samples are repeated multiple times during the trials. (Also, it was noted that these sample results are not provided until the end of the study).
So when they said "some patient sample test results" they could have meant one or more of a type of sample(s) had a problem and that it didn't apply to just "some patients". The problem could have been the same sample type indicated different types of treatment at different times during the trial.
Again, I believe that no one but PPHM knows for sure what the PR meant and they aren't talking for now.
Bungler,
I've tried to stay out of the conversations this week. More than enough pain to absorb. Didn't sell any and I feel I may have made a mistake but I've ridden it way down before and will again until I get some more details that make me totally give up on this company. Having said that, I'm more acutely aware of the need to be absolutely sure about the logic associated with this investment.
I don't mean to be contrary and I do appreciate your opinions but I have to disagree with your assessment. In my opinion the critical flaw with your analysis is that it assumes the coding mistake was made once and then the incorrectly assigned drugs were distributed in this same incorrect assignment arrangement consistently throughout the trial. It may or may not have occurred that way. I can conceive of scenarios where the screw up would have them randomly assigning drugs in a continuously varying manner but, not being intimately familiar with the actual process I don't know if these scenarios are probable or not.
To be candid, I would not have thought a screw up of this nature was possible in such a regulated and procedurally controlled industry and process. I know from reading their website that the coding company uses another 3rd party software product for randomization. Whether they used (misused) that software for our trial or God forbid had an under skilled and under supervised intern running the coding and continuously screwing it up I don't have a clue.
The fact is that there are scenarios where the drug could have been misapplied in all sorts of combinations and until further information provides clarity on this subject I'll continue to believe that. I haven't heard anything from the company, news or this board (and I have ignored a lot of posting on this board this week because of the profusion of nob heads that have shown up) that would make me believe otherwise.
Please let me know what I may have missed on this subject. I want more than anything to believe your scenario is the only option but I'm not there yet. The one saving grace is the percentage of people in the "treatment" arms still alive but I am now trying to figure out the censoring issue impact on this too.
Personally I trust Steve King and I absolutely believe based on my knowledge of the blinded trial process that there is absolutely know way to be blaming this on Peregrine management; UNLESS they were responsible to validate the training and experience of the personnel to perform the work and also verifying the processes and procedures were acceptable for the coding and distribution process AND didn't, AND the problem ended up being due to inexperience of personnel or screwed up procedures that they knew about (or should have if they did the audit) and still accepted before signing a contract.
In the nuclear world the utility is responsible for performing QA audits to assess these types of issues before accepting safety related services or materials from suppliers. If PPHM did not perform any audits and relied totally on the regulatory certification before accepting critical services from this company then shame on PPHM. I personally believe the coding company screwed up on their own and that their procedures were in good shape, as should also have been the case for the paperwork documenting the necessary experience for the "official" personnel assigned to do the work. Oherwise they wouldn't have such a significant experience footprint in the industry for doing this sort of thing. There must have been numerous audits from the other companies that have used their services.
I have a suspicion they let an inexperienced and under supervised individual(s) perform some work that they shouldn't have and the company didn't follow its procedures that I'm sure they had in place to double check the work. Maybe the software was screwed up and we can sue another company (read that with lots of sarcasm please).
Thanks FTM eom
CP,
You do know that the FISCAL YEAR runs from May 2012 to April 2013 don't you?
See form 10k from July 16.
FTM,
Here is an excerpt from the NJDenny provided link
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2191&EncHid=&userName=bavituximab
that you currently are having trouble with:
human anti-chimeric antibodies
[HACA]:
HACA samples are collected at screening, Cycle 3
Day 1, Cycle 5 Day 1 and at Study Exit. HACA
analysis will be performed at the end of the study
and reported with the final clinical study report.
I believe this information may explain why PPHM had no ability to evaluate or detect the issue until now. Were these possibly the samples that were being discussed in the PR? Could they have been detecting high levels of human anti-chimeric antibodies in the control group where none were expected?
It also seems to imply that they were working on the Final study report; which seems to imply either MOS was reached in the treatment arms or they were going to issue a final report without waiting for MOS trigger in treatment arms. Your, thoughts on this will be much appreciated.
Geo,
First, I'm on the road typing via phone which is slow and cumbersome so I'll not respond at length. Second, only greater than half of the 80 (not 120) in the treatment arms are still alive. I don't know what the percentages are for the control arm but definitely less than 50. Third, no one in the public knows exactly what the coding screw up's effect was on treatment and control arms. Was the mistake only associated with bavi treatment arms? How many treatment cycles? How many patients? What was the actual resultant treatment regimen? Can they even figure it out? These were 90% stage 4 and we have still 2 treatment groups that hasn't hit mos yet. That has to mean something unless the coding screw up was "non random" (I.e., foul play).
Wool,
Tough day to say the least. Looking closely at the news I see two things. First Peregrine is saying they don't believe the problem is with the independent contractors that performed the trials but with the single independent contractor that was responsible for coding and assigning the drug. I would think that the contractor for coding would have been a US contractor because it would seem to make sense with half the patient population in the US and it being a US manufacturer. This then means to me that the possibiliy exists that the problem could very well be that the treatment regimens might not have been consistent as they should have been. For instance with a coding screw up it may mean that the active treatment arm may have had patients receiving placebo for one or more treatment cycles and the opposite may have occurred for the control arm, they may have received bavi instead of placebo for one or more treatment cycles. Depending on what the scope of the drug coding screw up is and whether they can unwind it all and still have enough patients left that were treated consistently as they should have been to draw any conclusions is yet to be seen.
That's easy; there will be nothing in front of you and everything is behind you.
PPHMownsME,
I don't think the term "presentation" is the concern here. PPHM has a "meeting" with CS and fund people set up. If someone wants to refer to it as a presentation or a meeting I don't really see the difference. If PPHM is going to meet with investors they will have to provide information to them in some form or fashion.
The important point is if that "get together" is on or off. If it is cancelled then my first reaction is that its a positive. However, this is just a rumor. Can't tell from the AF information if he's trying to push it as good or bad. All conjecture of course.
PG,
If that is indeed true then my first gut reaction is that is extremely telling and positive. The first reason I could think of to cancel such a meeting is that trolling for dollars is no longer needed and probably PPHM may have been dissuaded by their imminent partner. The partner wouldn't want funds to drive up the price before they had a chance to accumulate if they plan on doing so.
Of course I'm sure there could be a negative reason too to be frank. The one that comes to mind would be that CS couldn't get any (or enough) fund reps to attend.
With my investment, I'll go with the former. Then again, AF could be providing incorrect information. What are the odds of that occurring?
PG,
He was just quoting a statement made from an earlier post that was itself retrieved from another board. He wasn't making that statement; he was just making the point that we should check out its validity.
Thank you drragmop. That shows quite well the type of person we are dealing with. Good job.
So what you're saying entdoc is that the drug can still fail? Just kidding. I was thinking of the dumb and dumber movie when I said that.