Avid Bioservices Inc (CDMO)

[MobyInvestor]

Review the ASCO posters for the three phase II trials with Bavi. They have a big section on Safety, and even criteria used to assess safety.

Oh, now we're referring to an ASCO poster.

Right...

The information on those posters are not defined/required by FDA regulation as is the information that's listed in clinicaltrials.gov:

* Required by ClinicalTrials.gov
FDAAA Required to comply with US Public Law 110-85, Section 801
(FDAAA) May be required to comply with US Public Law 110-85, Section 801

Primary and Secondary Outcome Measures
NOTE: When Results are added to a record, outcome measures are transferred from the protocol section to the results section.

Primary Outcome Measure FDAAA
Definition: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
o Title * - A concise name for the specific measure that will be used to determine the effect of the intervention(s) or, for observational studies, related to core objectives of the study and receiving the most emphasis in assessment. (Limit: 254 characters)
o Time Frame (FDAAA) - Time point(s) at which outcome measure is assessed. (Limit: 254 characters)
o Description - Additional information about the outcome measure, if needed for clarification. (Limit: 600 characters)
o Safety Issue? (FDAAA) - Is this outcome measure assessing a safety issue? Select: Yes/No

Secondary Outcome Measures FDAAA
Definition: Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.
http://prsinfo.clinicaltrials.gov/definitions.html

Cut it any way you want but the fact remains, only the Bavi + Docetaxel for ABC had an outcome measure that was designated as a safety issue.

Regards,

moby