Replies to post #54725 on Avid Bioservices Inc (CDMO)

[Thurly]

Moby, you don't necessarily know what any of that means. For example, explain how the following from one of the bavi studies:

http://investorshub.advfn.com/boards/post_reply.aspx?message_id=52898681
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Control: Uncontrolled
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Immunoglobulins Bavituximab Globulin, Immune
U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
adverse events [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
laboratory evaluations [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
human anti-chimeric antibody [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
pharmacokinetic analysis [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

How is it possible that the primary and secondary outcome measures both indicate "Designated as safety issue: No" when the endpoint classification is "safety study"?

I think you've put too many eggs in the "Designated as safety issue" basket.