Avid Bioservices Inc (CDMO)

[biopharm]

Accelerated Approval: Basing approval not on a clinical endpoint but on an agreed upon surrogate marker, that is a measure such as blood test or urine marker, that is believed to be indicative of a disease state and treatment effect,

R622191675, in addition to this new FDA guideline where they specifically spell out bloodtests, if Peregrine receives BTD for another indication... I found page 17 of 40 of interest: ---- now I believe this below has flipped-PS written all over it...... Peregrine is being quiet for a very good FDA final revision guidance reason.

In a breakthrough therapy designation request,
a sponsor should provide justification for why the endpoint or other findings should be considered clinically significant. In rare cases, a pharmacodynamic (PD) biomarker may be considered a clinically significant endpoint if it strongly suggests the potential for a clinically meaningful effect on the underlying
disease. In such cases, a sponsor should provide evidence supporting the use of the PD biomarker. Such evidence should include, for example,

(1) the extent of understanding of the disease pathophysiology,
(2) whether the biomarker is on a causal pathway of the disease
process, and
(3) the time course of the drug’s effect on the biomarker (e.g., the biomarker can be measured earlier than a surrogate endpoint used for accelerated approval). In addition, strong evidence of the drug’s effect on the PD biomarker generally is expected.
FDA is more likely to rely on a PD biomarker for breakthrough t
herapy designation in a disease setting in which there is no available therapy, if the evidence supports such use.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

Pharmacodynamics is the study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect.

http://en.wikipedia.org/wiki/Pharmacodynamics

Now as everyone reads this.... again, remember Dr. Brekkens slides (new slide at 13 minute mark) from his webinar that JBainseky post detailed:

The slide is divided in half, left half "Associated with positive outcome in cancer patients" and the right half is "Associated with poor outcome in cancer patients". The key point is the amount of MDSCs. This isn't specific to BAVI, but to the tumor environment.

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