Replies to post #205613 on 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.

---------------------------------------------

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

[md1225]

The increase in size of Avid capacity is for the potential launch of bavituximab.

The FDA "will not halt the trial" unless Peregrine has the capacity to produce bavituximab with commercialization possible.

It will be possible by 7/15.

[Protector]

I don't think I am wrong. There are much more arguments for my point of view and here are some more.

It's your opinion, but you're wrong. The e-mail was drafted last month and the documents (bavi launch scenario #1 and #2) were given to opposing counsel in 2014, months after the Fast Track designation was granted.

Make a difference between the moment that PPHM hands something over and the availability of the original data they are handing over. The facts reported by Jeff Masten were also handed over almost TWO YEARS after he did his investigation. Furthermore Lawyers take time to build these files and it would be totally unreasonable that PPHM before the receiving of the FAST TRACK would not have a launch planning for Bavituximab (they are building complete manufacturing facilities for Bavi - what because they had to make this planning for the Law Suit and then suddenly realized they had to start building manufacturing facilities?).

Furthermore why would PPHM forward the possibility of a launch in JAN 2017 in the CSM Law Suit. Very simple. They COULD NOT "NOT" do it because CSM would immediately point to the FAST TRACK themselves if only JAN 2018 would be scheduled. WHILE if it is based on an INTERIM LOOK IN PPHM could EASILY SAY that that is SPECULATION because NOBODY can anticipate that the trial will be stopped. So the damages for delay to market must be based on what is SURE TODAY and that FAST TRACK is the EARLY TRAIL STOP is NOT.

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.

We all know that is not correct. Ok the 4 months is one thing but the WRITING of the BLA (and everyone that was on the annual should have pumped that in quite well!) is the big job. That is where PPHM wins MUCH MORE TIME thanks to the Fast Track the the 4 months FDA response time that goes off! They can write, send in, discuss and adjust part of the BLA at this moment (Garnick said they had already 500K pages ready) and that is why when SUNRISE is unblinded they only need to process the new data and add it to move on with the FDA.

Other companies that do not have the Fast Track can compile the data before unblinding too but they can not send it in, have it processes and discussed, ect and need to start doing all that after unblinding for a terrible amount for data.