Avid Bioservices Inc (CDMO)

[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.