Wednesday, October 17, 2012 12:14:33 PM
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.
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