Avid Bioservices Inc (CDMO)

[Protector]

jbainseky, the answer is simple and straight forward.

JB wasn't trying the wheel in the final unblinding contract for CSM's good but because if CSM got the job then SHE would have been involved. The final unblinding was NOT done by CSM and she knew it wasn't gonna. Yet she created a situation where this trial actually COULD NOT be unblinded without her and her two folders full of secret records and her Excel file (see testimony's).

That is why she brought up the unblinding at the kick-off and that is why PPHM's Leyco says he was under the expression JB was pitching to get the unblinding done by CSM. And of course she was all in over her head, she saw at the meeting that that chicken wasn't going to fry. And your version that she brought it up for other reasons doesn't fit the testimonies. She was told at the kick-off things had to stay as they were planned.

That the unblinding procedures are different depending on the trial is not an excuse. JB had access to the trial protocol, knew exactly what unblinding was expected and because she had access to the PPHM/CSM protocol (she signed it) she knew CSM didn't have to do ANY randomizing nor OTHER unblinding then what was requested. If you claim she didn't have the active know-how we may at least assume that with her education she had the capacity for passive understanding of what she signed, don't we, or are we going to add JB was retarded or signed the documents without reading?

The word 'try to improve it' isn't even applying. If I ask for service A up to a certain degree then it is because I only NEED or WANT the service up to that degree. Giving me something that I did not ask for, and crosses my intentions, is not an improvement.

If I buy a 500cc Mercedes would JB improve it for me by giving me a 600CC version of the otherwise same car without paying extra, just because she knows it exists and is a better and string engine and drives smoother? No. If low gas consumption is my goal and reason why I ordered the 500CC in the first place then giving me a 600CC is not an improvement.

It is exactly the same here. PPHM didn't want to know the individuals assigned to the trials specific arms but they wanted to know what arm was what dosage. They carefully picked the degree of blinding they wanted and was acceptable in the trial design the FDA approved.

A) JB made sure NOBODY but here knew the real results
B) that the trial could not be used as registrational
C) she knew the blinding procedures very well because she KNEW CSM needed to do the unblinding for HER having control over it
D) And there is NO WAY on Earth that you could make hard that the second partial dose switching was part of any improvement or even track covering. SHE COULD NOT COVER HER TRACKS BY SWITCHING 25% BETWEEN BOTH ARMS.


So now for your scenario to work we need to ASSUME:

- JB, vice presiden and president of the North Dakota Pharma Assoc and 13 years of experience in Pharma Industry and 8 year with CSM at that time, didn't understand the blinding/unblinding written in black & white in the protocols she sighed. I hope we may assume she could read, because you are really being degrading JB to the status of near moron to make the scenario work ?

- out of her good hart and against protocols of PPHM, CSM and FDA she tries to improve what she doesn't understand.

- Then she suddenly want to UNDO her improvement (because from where JB stand at that moment there is NO PROBLEM why would she try to cover tracks of something she believes is a due improvement for this trial). Why undo her improvement? How did she SUDDENLY come to the conclusion her improvement was one she could lose her job over?

- Then while having done so much good (from her point of view) she leaves CSM and tells nobody. Furthermore when asked by Ghelen she lies about her good doing in e-mail.

- AND YOU HAVE NO FOOT TO STAND ON TO MAKE THE TRACK COVERING STORY HARD AS AN EXPLANATION FOR THE SECOND 25% PARTIAL SWITCHING, BECAUSE BLEECKER HERSELF TESTIFIES THAT SHE DID WHAT SHE HAD TO DO! So why would she have tried to cover any track or not inform anyone if she STILL TODAY (well 14 days ago) claims everything was done as expected by PPHM/CSM/FDA. Are you saying she is lying on the record? Why, she cannot loose her job any more at this point and that was the reason you gave for her to NOT TELL at the time (which doesn't fit your doing good or human error or improving the trial attempt).

There is a 3rd PARTY, no more no less and when we start talking about the SECOND clinical trial that is on issue in this lawsuit and was mentioned but not identified by the CSM lawyers, and which is one WITHOUT unblinding (because PPHM had no other blinded trials running and which very probably is the 1st ln NSCLC - assumptions) then you will see that the good doing, messed up and cover tracks for fear of job loss, etc doesn't hold, AT ALL!