Avid Bioservices Inc (CDMO)

[EYEBUYSTOX]

Earliest Launch of Bavituximab according to PPHM:

Amazing price considering we could see "trial halt FDA approval" possible on first look-in by August/September 2015.

MD,

Did you happen to read the recent court filings? PPHM is seeking $2B in damages from CSM based on items cited in the "term sheet" Abbvie delivered the company. However, one of the most important pieces of information in the court documents is the projected launch of bavituximab.

According to an e-mail written last month in the court filings, PPHM gives two possible launch scenarios for bavituximab. The first is Q1 2017 and the 2nd is Q1 2018. My guess is that with a Q1 2017 launch that would mean that the 2nd interim look was statistically significant (best case possible).

Working backward you can roughly extrapolate the timing of the 2nd interim look. If bavituximab is launched in 2017, the earliest the 2nd interim analyses can be done is in March 2016 IMO. Here's an example of a trial that was stopped after it's 2nd interim analyses.

Bayer's Nexavar (sorafenib) was granted Fast Track Designation for HCC. Their HCC trial was halted due to successful survival numbers in February 2007. The drug was approved in November 2007...9 months after the trial was halted. So, best case scenario FDA approval can happen 9 months after a trial is halted early.

According to Rob Garnick the company is going to be ready to launch the second the receive the letter from the FDA. So, again, best case scenario according to PPHM is Q1 2017 (Jan 1 best case). 9 months prior is March 1, 2016.

There's almost no chance the trial will be halted after the first interim analyses. The statistical powering needed would be astronomical and unheard of. But I do agree that the first look-in will happen in 2nd quarter of 2015. A PR will follow that will say, "The data monitoring committee agrees that the SUNRISE trial should proceed as planned."

So again, how will the company finance itself until that 2nd interim analyses? Is a partner going to step forward before SUNRISE reads out? Pretty risky IMO.