Avid Bioservices Inc (CDMO)

[EndtheFed1776]

CP,

I've been investing in biotechs for over 20 years. It has always been my understanding that a P value greater than 0.05 was considered to be statistically significant. The FDA commonly requires two trials showing efficacy, a phase 2 and a phase 3 or two phase 3s. They want to ensure that the one good trial wasn't just a random outcome. Since the unavailability of a drug for a cancer patient can lead to death, the FDA has been more tolerant for life threatening diseases and may approve a drug based on clinically significant P2 data alone. Peregrine may have gotten bavi approved based on the P2 data but for Jeneatte Bleaker's (sp?) activities. You asked for FDA documents stating that a P of 0.05 or better is standard. Please see the following at footnote 5:

http://www.fda.gov/downloads/Drugs/.../Guidances/ucm078749.pdf

Please also see the following NIH document about 30 paragraphs down:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534930/

>It is widely known that the Agency will conclude that a trial is considered “positive” if the p value generated for the between-treatment contrast is less than or equal to 0.05. What does this mean?<

So my questions for you and the others are as follows:

1. Did Peregrine get a SPA for the SUNRISE trial from the FDA?

2. If so, does the SPA require a P value of 0.02 or better for SUNRISE?

3. If there is no SPA for SUNRISE, where is the 0.02 or better P value coming from?