Avid Bioservices Inc (CDMO)

[biopharm]

Accelerated Approval:

I know its been mentioned before about the possibility of Bavituximab getting "regular approval" vs. Accelerated Approval and if things continue with the IST's with data as compelling as the NSCLC ph. IIb trial I say that would cause lots of friction in the BP arena.

Below is taken from the FDA site:
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM259421.pdf
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A. Endpoints supporting past Approvals

In the past, three commonly used efficacy endpoints in trials assessing treatments of lung cancer 67 were overall survival (OS), time to progression (TTP) or progression-free survival (PFS), and 68 objective tumor response rates (ORR) (see Table 1). ***************************************************
The majority of drug approvals for NSCLC 69 have been based on significant improvement in OS, which is an optimal endpoint because the 70 measurement is accurate and represents direct clinical benefit to the patient.
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Similarly, reduction 71 in patient tumor-related symptoms can also demonstrate direct clinical benefit and can support 72 regular approval.
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