Replies to post #171344 on Avid Bioservices Inc (CDMO)

[geocappy1]

Simple logic tells me the answer. The control group had an original result of 5.8 months MOS so it was within the range of historical data so it must have received some bavi but not so much as to make it perform all that well. The 1mg Bavi group got some placebo but not so much as to be very detrimental to its overall results therefore it must not have gotten that much.

Bottom line is that since the exact amount received is most likely unknown they decided to combine the control group and 1mg bavi group. FDA seemed ok with it so they sent it on to ph III with Fast Track and two early lookins.

The rest really doesn't matter and the exact happenings will not be found out unless she decides to talk. Either she was paid lump sum and somehow the authorities can track or she is being paid a little at a time at a job which she is unqualified for at a salary that is a payoff for what she did.

[asmarterwookie]

HI CP...a labeling data base would have been set up for ARM A, B and C. Not a data base of patients...Just labels as CSM knew there were 3 arms...1/mg/kg, 3 mg/kg and Placebo. Patients would entered into the system as they signed up.

Those labels would have been set up on a computer. Patients would then be entered into that labeling program...name height, weight etc...Was the patient already randomized or did the labeling program randomize? I don't know...regardless....if the labeling program had a Trojan program secretly installed and undetectable it could realistically take the information you just entered and do with it as it wanted...from changing A to B or B to A or any other parameters including weight...the operator could enter everything correctly but as soon as enter was hit the Trojan would take over covertly with the computer operator non the wiser or anyone else for that matter.

The Trojan of course would have a self destruct at the end of the enrollment..ie once the program counted 121 patients or any parameter that the bad guys programmed it to do.

Normally CSM wouldn't have any access to the source code of such software because it is very probably something (a package) they bought.

I hope Carlton included this as getting to the bottom of it.
Who else to create my mythical Trojan Virus?


AM I really the only one who thinks this way?
Catching up if more was already discussed on this titillating topic.

wook

[skweze]

The First Amended Complaint filed on March 28 alleges with specificity that the switching was deliberate (compared to the more general allegation of "errors" in the original complaint):

17. On April 15, 2010, CSM's Project Manager confirmed again to Perceptive and to Plaintiff that CSM was following Perceptive's instructions and Clinphone Protocol. However, CSM's Project Manager's confirmation was false because CSM already had secretly and unilaterally swapped the A and B arms so that those patients that were randomized to the A arm (control arm) and supposed to receive placebo treatments, were actually receiving 1 mg/kg bavituximab treatments and vice-versa.

18. Peregrine's investigation in Fall 2012, revealed that CSM committed other labeling and distribution errors affecting the A and B arms above and beyond the swap of the A and B arms noted above. Further, CSM did not inform any other clinical vendor and did not disclose that CSM had made any sort of Clinphone Protocol change at all. CSM's Project Manager did not even advise CSM's own Director of QA that CSM had changed the Clinphone Protocol.

It will be revealing to see CSM's answer to this complaint, which should be due 21 days after service. (Unless they are given an extension.)

Switching the complete arms must be MORE then just a database thing. Here is why...