Avid Bioservices Inc (CDMO)

[patientlywaiting]

While we wait and try to understand what happened how about this train of thought. Back to the wording of the Black Monday PR are we confusing the use of the phrase "coding" and "Investigational Product" to relate to one another. If you separate the two they become different elements in the sentence. For the "SHOW ME THE MONEY" guys you can probably skip the rest of this post.

So this is my spin:

Definition of "coding"

coding: In clinical trials, the process of assigning data to categories for analysis NOTE: Adverse events, for example, may be coded using MedDRA.

source: CDISC 2009 Glossary

http://www.cdisc.org/stuff/contentmgr/files/0/08a36984bc61034baed3b019f3a87139/misc/act1211_011_043_gr_glossary.pdf

From Clinical Data Interchange Standards Consortium http://www.cdisc.org

If you take the original PR and replace the word "coding" with "data analysis" (the categories being "treatment group") it reads entirely different.

September 24, 2012

Peregrine Pharmaceuticals Announces That It Has Discovered Major Discrepancies in Treatment Group DATA ANALYSIS by an Independent Third-Party Vendor Responsible for Distribution of Blinded Investigational Product Used in Its Bavituximab Phase II Second-Line Non-Small Cell Lung Cancer Trial
The Company Is Currently Conducting a Detailed Review, Including Assessing Its Impact on Overall Trial Results; Investors Should Not Rely on Previously Reported Clinical Data Disclosed From This Phase II Trial at This Time; These Recent Findings Do Not Impact Other Ongoing Bavituximab Clinical Trials

TUSTIN, CA -- (Marketwire) -- 09/24/12 -- Peregrine Pharmaceuticals (NASDAQ: PPHM) announced today that during the course of preparing for an end-of-phase II meeting with regulatory authorities and following recent data announcements from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer, it discovered major discrepancies between some patient sample test results and patient treatment DATA ANALYSIS assignments. Due to the double-blind nature of the trial, Peregrine was not permitted to have access to either patient group assignments or related product DATA ANALYSIS information. As part of the trial's execution, Peregrine contracted with independent third-party contractors to execute treatment group assignments and oversee clinical trial material DATA ANALYSIS and distribution according to established procedures. A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to ANALYZE DATA and distribute investigational drug product.
This discrepancy is specific to this trial and will have no impact on other ongoing bavituximab trials.

Also in support of the definition of the phrase "coding" I found this:

http://www.lexjansen.com/pharmasug/2009/ad/ad13.pdf

What led me to this was reading this:

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2497

and from this document on page 12 is this line "(4) All electronic drug accountability records must be FDA compliant (see 21 CFR Part 11)." which led me to this:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf

Some of the key points in this are lines 135 through 146 also lines 222 through 227 which don't have to do with "coding" specifically but the controls that are involved in The Clinical Trial process and documentation required by the FDA.

I believe dosing was consistent throughout the trial. I'm thinking return of data to CSM for "coding" or "data analysis" from Trial Clinics led to a clerical error. One can only hope!

As our moods rise and fall with the sun and the moon if you were to ask me today I do believe this will all be sorted out shortly. Week one after Black Monday was gather the data. Week two was sort and validate. Week three will be FDA verify. Hopefully the days before ASM will confirm all this.

My one allowable post for the day.