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Saturday, September 29, 2012 10:50:44 PM
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).
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