Assume 2n ln NSCLC Sabotage
I know, a high Hollywood grade title for a PPHM post! However I want to take you back in time to the beginning of the Discrepancy case.
Those of you who read my “Analyze It Better” posts will have noticed that, while the first versions included references to gov agencies such as FDA, FBI and SEC, these where gradually left out in later versions as time evolved. There was a reason for that and in this post I’ll explain why and why I bring it back up now, while some may have noticed that I gave a hint in that direction already last week when I wrote that Peregrine’s internal investigation did not exclude that an external body was still conducting an official investigation.
You’ll understand that the sabotage theory is always a little controversial and therefore I pushed it in front of me to a period where more detailed information on the 2nd ln NSCLC is going to become available and there will be no hiding as of the real nature of the error. A good thing is that it will end our speculation.
The initial trigger to name the FBI, FDA and SEC was because these where the agencies that could have been concerned with Peregrine’s PR of Sept 24th or could have been called in, in the case of sabotage.
The FDA will certainly have been involved to check how a CRO (CSM) that they licensed could end up messing up the data. I cannot, with the best will in the world assume that this happened and that the FDA says: No problem, just carry on CSM.
Until today, and we know FOR SURE that the review of the data is done and the nature of the error known by Peregrine, and therefore also by the FDA, and no action has been taken against CSM. No suspension of their license neither ANY other preventive action to avoid the same error to occur in other trials or whatever! Strange isn’t it!
This COULD point to a non-systematic error and that can only be two things. An honest human error or an error made at purpose, which one calls sabotage. An honest error could be made once but not repeatedly on SOME patients because that would point back to some procedure description problems in which case the error would have to be made consistently on ALL patients to qualify as an honest human error, which would be an error in the procedure description resulting in coding and labeling errors, but it is not. FTM already demonstrated that the error is one with low impact on the control arm MOS and therefore not on an important part of the patients and SK said SOME patients.
So, actually even only considering the data that dropped in till now there sure is a pointer to sabotage. Furthermore the black Monday PR placed it at the coding and labeling level. And actually that made me think about sabotage even before the two posts on this PPHM board that mentioned that IR messaged that an external body was investigating. Remember the eddy currents on this board when later on Peregrine suddenly referred to THEIR internal investigation and how some posters attached all kinds of conclusion about that, moment as of which sabotage theories faded away (I’ve even explicitly supported that process by removing it from the “Analyze It Better” posts).
Although I was thinking about bringing the agencies back in when Carlton on the last Annual Meeting said that they we are going to the bottom of it, and while English is not my 1st language I still think to be correct when I say that this expression holds at least a stronger connotation and means more than just “we’ll find the error and will let you know”, I decided not to because at the time Bungler posted that he checked if CSM was served and CSM wasn't served. The reasoning was that Peregrine may be working with CSM, need CSM, in case something more than an honest human error was involved and hence didn't want to start a court war.
And then came the Jan 7th, 2013 PR. We get a PR about the discrepancies that is useful but hides the nature of the error, for which we’ll have to wait for the detailed results. As some posted, why didn't they give us the detailed results because they must have them otherwise they couldn't have given us the synthesis and they never could (would/should) have said they move to the FDA’s end of stage II meeting.
As an extra, CSM is still not served today and wants to hire someone for the CODING activities. And as some have already assumed this could point back to the Coding and Labeling of the Sept 7th PR. Some will say that is stupid because a CRO as CSM must be hiring coding agents all the time. Well we didn't see any since Sept 2012, CSM isn't served and CSM isn't suspended by the FDA but happily keeps hiring and business as usual. On top of that complete radio silence about the lawsuit and the serving on both sides.
Well, that is not normal anymore. If the FDA didn't take any action and Peregrine doesn't serve and Class Actions suddenly stop advertising (and have even been cleaned out of the NASDAQ news page retroactively – which is the first time I see something like that) then there must be a cause to the errors that justifies all that. I know only ONE CAUSE that would 100% match with ALL of these observed facts and that is sabotage.
I know some will say that writing such things could be bad for my reputation as a poster but then just think I don’t write to disturbed the board but just because I see a possible path and provide the reasoning that led to that conclusion. I know that I stick my neck out but it is not bad to go on your face from time to time to bring one back to reality.
Here is why I think sabotage is the only possible path left. Class Actions are without any ground if an act of sabotage would be at the basis of the error, unless it is one of the 4 people mentioned in the filing that did it or ordered it (ordered it because a double blinded trial can only be sabotaged if you corrupt someone at the CRO. Garnick, Shan and SK have certainly never set food at the facilities during the trial). In all other cases, if they are not involved, they couldn't know and therefore couldn't have planned any PR strategies to make money from the stock. Furthermore that would be easy to prove as transactions are recorded.
But, did they KNOW the 7th that there was a problem and should they have held the PR in to avoid recalling it the 24th?
The answer is definitely NO! Why? Well that is where the FBI comes in. The answer is NO, because if the discrepancies are discovered and they would suspect sabotage (an believe me if you know the nature of the error and you understand how the trial must be procedurally conducted according FDA guidelines and rules) and you are SK, Garnick or Shan it will not take you very long to say if sabotage possible or not possible.
If the answer is “possible” you need to involve the FBI or at least a police detective investigation depending on the geographical scale and nature of the complaint. Then you time-stamp the finding of the discrepancy and you could never ever get away with claiming discovery of the discrepancies “on or about Sept 20th” as the PR of the 7th explicitly mentioned. Hence, class actions without ground!
But, in this case, CSM isn't really at fault. CSM is liable because sabotage can only have occurred under their noses, but should have procedures to avoid it. If CSM recognizes this then settling with Peregrine is better for everyone because for the rest both their names would be cleared in case of sabotage by employees, sub-contractors, etc. Those people or parties were not asked, nor instructed by CSM to sabotage the trial, that is a criminal action out of their will and control. Not serving CSM and no FDA sanctions against CSM therefor points in the direction of sabotage.
The only thing that isn't clear to me is how do you sabotage labeling and coding, at least if Peregrine’s first indication that it is labeling and coding is correct because it could be something else.
I would think that in a clinical trial the name “Golden Trial” worthy everything is double checked. So in case of sabotage we must be dealing with a group of people because you need the labeler, the checker of the labeling and the double checker. That’s at least two to three people. That’s the only part that troubles me.
I believe in the goodness and honesty of people and I am not stupid so I know that there are rotten apples among them but 3 rotten apples in a same company on the same clinical trial that do not, like a bunch of Ocean Eleven gangsters seek each other out but must be EACH approached, is a lot of people to keep a secret.
Approached, yes, because if not they needed an incentive to do the sabotaging! What could that have been? The possibility to go to jail, the risk of losing your contracts with CSM if it is a 3rd party subcontractor, the outlook of losing his job in case it is an employee of CSM or such 3rd party! Nope! So yes approached.
This is where the interesting part of this post begins. If you allow me to assume sabotage based on the fact that there is at least sufficient substance to not exclude it (notice my conservative approach :) then why and on request of who?
If someone wanted this trial to be sabotaged then it must be because they are afraid of the results. Really afraid because sorry, Peregrine is really not a threatening BP in biotech land. So the party that has that fear must have known about a CERTAIN HUGE potential of Bavi! But then why don’t we know. We know Bavi works and has indeed big potential, and I believe that 100%, but if I would have to make a “certainty” statement well then I can only fall back on public information and there is a difference with good and extraordinary threateningly good!
It is when last week I looked into that April 15th Encrypted message at the SEC that my light bulb suddenly lighted up and that I added this last part to this post. Breast Cancer! All the questions about what happened with breast cancer Bavi, why don’t we do anything with it, how come tumors disappear and Peregrine just leaves it by that! When I correlated the PR of the same day the closed SEC listing was posted and saw it was the Breast Cancer result announcement I figured that the answer is in the sealed SEC message. And whoever ordered the sabotage of the 2nd ln NSCLC knows more about the results of the Breast Cancer trial, suspected that the 2nd ln NSCLC would go in the same direction, and I don’t even exclude some irregularities with the 1st ln NSCLC control arm results, and had an incentive to not let it happen or at the least slow down Bavi.
Combine the above with JonnyRockets popular expression : Someone is keeping the lit on our pps, and even extrapolate it to the huge anti-PPHM press and I think Carlton didn't just say “We’ll go to the bottom of this” because he was bored to death and found he had to fill the room with noise!
Something tells me that some don’t like Peregrine to become the Microsoft of Biotechnology but remember, we are protected, Cloak Protected :)
