Replies to post #179167 on Avid Bioservices Inc (CDMO)

[spankyvol]

It was sabotaged. 99.9999%
They know, others also know much.

[BCS Paladin]

Fact is Phase II data was good, real good.

Yes there was a little problem with Jeanette

Data was good

Results were good

Phase study was good

Any other "FACTS" are poor opinions.

ASK THE FDA

[Couch]

The new reconfigured data is obviously not as good as the data originally reported.

Do you have one single solitary shred of evidence to back this up?

[Jeff4iam4]

I completely disagree. Although I am not going to say it was 100% sabotage, it was clearly a deliberate act to switch the labels by at least one person....sounds pretty close to 100%...so I am going with 98%. PPHM clearly said in their legal filing against CSM that an employee deliberately switch the doses. Why would they make that claim so specific if they were not told that initially by CSM? They wouldn't....and CSM has not disputed that either to my knowledge, just that they don't feel they are liable if it was the act of an individual. As far as why nobody was arrested being your main point as to why this is not sabotage, that isn't quite the slam dunk you portray it to be to support your opinion. There are several probable reasons why no arrest was made:

1) The individual who made the labeling error (sabotage) may be claiming it was just a mistake. She just had a senior moment and didn't check her work. Hard to prove otherwise unless she slips up.

2) If she was paid to sabotage the trial by a BP, believe me when I tell you that it would have been done so covertly that even the CIA would be proud. BPs have big money and they are not stupid....they can create networks of espionage and covert actions that are pretty sophisticated. I bet she even has a big bag of money in cash hidden in some bank vault or maybe in her parents attic or basement that she can just grab needed cash from when she feels like it....and maybe she will be more daring to spend more of that cash 10 years down the line when all the heat is off and it becomes a dead issue.

3) CSM may have protected her initially as maybe she had a good rep with her coworkers and they initially bought her story that she just made an error. Maybe she was good friends with everyone who worked there and you tend to protect your friends. And when she left and they found out the truth, their covering her initially might have put them in deeper for liability, so now they are more silent than ever.

4) Law enforcement is a funny thing in this country. For matters of this nature, the criminal act most likely needed to be reported to the authorities before they look into it. Maybe because of 3 above, CSM didn't report it. Maybe PPHM didn't either as they expected CSM to do their internal investigation and left it to them as to how to handle it. But, let us say that it was reported to the FBI. Well, another funny thing is that they don't usually arrest people for acts like this unless they have clear evidence that it was a criminal act. So, the woman claims it was an honest mistake, the FBI cannot find a solid connection to a BP, her bank records don't show a large sum of money in any of her accounts and they don't have enough evidence to convince a court to allow them to search her home or parents home for big bags of cash. So what can they do? They need evidence and usually a lot of it before dragging her in and filing charges against her. Although what she did may be criminal, she may have covered her tracks just well enough to keep from being arrested.

So, those are my main thoughts as to why I believe your assertion that there was no sabotage because no arrests have been made. You are of course entitled to your opinion, but I feel your points lack strength to convince.

[asmarterwookie]

Fact is no matter how you slice it one can't say the tainted data was sabotaged and be correct

Sabotage is a basis of intent.
No matter how it is sliced.....

Can you prove intent?

Maybe with a confession, money trail, finding the discarded thumb drive with the "label switching virus"(my deduction), EMAILS stating intent.....

Ultimately sabotage fits as there was an act to slow down or stop a companies progress. PERIOD. Deny that and open the credibility window.....
Go PPHM!!!!!

wook

[Protector]

You are jumping into a lot of conclusion here.

...one can't say the tainted data was sabotaged and be correct. If it was indeed sabotaged there would be an arrest and mgmt would state that fact.

1) The data cannot be tainted because it passed the FDA PIII approval and got a Fast Track. The FDA would never give that based on tainted data, they did on SALVAGED data. This salvaging must BY CONSEQUENCE have been of a SATISFACTORY type for the FDA.

2) If you like to call the data "tainted" then it can ONLY be because of some action that tainted it in the first place. So what else could that be then some activity that resulted in making a sufficient change to the data so it could be called tainted.

3) PPHM for long did NOT in any way say anything that 100% sure equalled MALICIOUS INTEND. The best we had last year was "clear evidence of dose switching" which did not 100% sure qualify as malicious intend. However, every time the word sabotage was used (by me and others) the reply has been, by you and others, that PPHM NEVER said anything about intentional tempering let alone sabotage.
It was MOMENTUM argumentation because INDEED at the time we could not present any PR or other document or public statement of PPHM that used such wording.

4) TODAY however we can present the filing before a court of Law against CSM (the CRO from Fargo, ND) that clearly has PPHM declare that it was NOT just an honest human error but that a "she" (a woman) made changes to the trial, wrote mails with false information and did not perform the expected tasks while claiming she did. So now PPHM HAS clearly made the statement as was asked for in point 3 above.

So now it is sabotage. There is no need for an arrest to be made. The "she" may have accomplices, there may be a search for who is behind it or at least a WHY? There may have been a deal made in that area. And it is certainly not Carlton J that will conduct that investigation, neither PPHM. Such an investigation is the result of a possible criminal complaint against the "she".

...that it was sabotage is untrue until it is actually proven otherwise it is just someone's wrong opinion.

There is no matter of OPINION here. PPHM has pointed to prove and clearly identified at least one "she". They would not have done that before a court of law if they didn't have the prove to make this hard in their files. They have TOO MUCH to lose playing such games.

But AGAIN before it wasn't sabotage because PPHM never used explicit wording that indicated malicious intend, now that they do another momentum argument is pulled out of the hat and it suddenly needs to be proven. Well just like PPHM, as we predicted, started labelling this in the category malicious intent, no matter how we call it, so it will be proven too. Just a matter of time, MOMENTUM arguments as i said.