Avid Bioservices Inc (CDMO)

[masshysteria]

This is awesome cheynew - thanks for posting.

From having peripheral engagement in clinical trial coortination and implementation protocols, some thoughts to share (I am not an attorney and am sharing 'perspective' and opinion - not legal fact based position)

1. In present times, nearly all pharma uses some form of third party clinical trial management/coordination companies. These companies, and their employees, are subject to the most intense and deep training regiment to assure adherence to all the regulatory, medical and procedural elements this type of work requires. A goof up of this nature is almost impossible in this scale and breadth - considering the experience and years in service for this company.

2. The activities carried by the CSM would typically have 2+ layers of oversight, inclusive of the person(s) responsible for the labeling, packaging, distribution or other work. This would likely require a multi-level of failure, which is highly unlikely to have occurred and is more-so a tell-tale sign of criminal intent with collaborative profile beyond a single player.

3. Finally, contracts I have seen for this type of work always put the overall organization (CSM) at full responsibility/accountability for delivering the services and outcomes per contract. Even if there was a 'rouge' employee, or a group of them, ultimate liability is with the contracted entity to deliver services per spec. They, or their insurance firm, will be liable.

It will be a nail-bite inducing anticipation as we wait to see if CSM eats it without pursuing the employee (settle with Peregrine, block further investigation), or claims no liability and criminally pursues the individual. It will be a hell of a ride!

Much appreciation for sharing,

MH