Avid Bioservices Inc (CDMO)

[biopharm]

All the fast track does is take off 4 months of review time assuming a priority review is granted vs. a standard review. There would not be a year difference in "Fast Track" approval vs. standard approval. That's also a fact.

True, it does officially say 10 months reduced to 6 month but we have never before seen a drug such as Bavituximab with such a broad application across so many cancers/autoimmune diseases..etc and maybe it means the difference of a year based on rolling review and making 100% sure that 99% of the BLA paperwork is completed and submitted. I believe this BLA filing will clearly outnumber any other BLA filing that Dr. Garnick has worked on and that is why he stressed how important it was, the process..etc during the ASM.

The last thing I'd want is for Peregrine to have to wait to send a truck loads worth of BLA paperwork to the FDA... ok, electronic filing these days : ) "after" Sunrise DMC stops the trial. If 99% of the BLA paperwork is completed when Peregrine is informed that the DMC has officially stopped the trial... then things become Intercept like pretty fast. Its not often that retail investors can be invested in a biotech stock under $5 before the majority of funds are allowed to even buy.

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Priority Review: (I believe Peregrine filed already)

Requested alongside Biologics License Application (BLA) or New Drug Application (NDA) submission

Cuts a drug’s FDA review period from ten months to six

Drugs qualifying for Fast Track, Breakthrough Therapy, and Accelerated Approval can also be eligible for Priority Review

The Perfect Candidate: Priority Review gives extra FDA attention to any drug with the strong potential to improve treatment of a serious disease. Drugs treating cancer, AIDS, Alzheimer’s, heart failure, Hepatitis C, diabetes, and many other serious diseases are frequently granted Priority Review.

http://www.focr.org/priority-review

Fast Track: (Peregrine already received)

Requested as early as Investigational New Drug (IND) application and prior to BLA or NDA submission

Intended for drugs that address unmet medical need by either treating a condition for which no other treatment exists or offering some substantial benefit over existing treatment

Sponsors get extra opportunities to meet with FDA, discuss approval requirements and study design, and identify their most efficient path through drug development and review

Sponsors may also gain access to rolling review, wherein portions of their marketing application may be reviewed before the complete application has been submitted

The Perfect Candidate: Fast Track designation is best suited for promising drugs with the demonstrated potential to improve treatment of serious conditions that nevertheless lack the early clinical evidence or magnitude of effect required for Breakthrough Therapy designation.

http://www.focr.org/fast-track

http://www.focr.org/fda-expedited-review-programs