Replies to post #262081 on Avid Bioservices Inc (CDMO)

[Dragon Lady]

Quote BS LOL, ""a failed phase III"? Study is continuing or ongoing, not recruiting more participants. Ethics requires following those who have not evented or otherwise disappeared."

WHAT???? Ethics WHAT?????????? NOT according to Peregrine Sr Mgt and their very public PR statements? TOTAL BS that the trial is somehow "continuing" in any way, shape or form?

The trial is STOPPED. OVER. DONE. HALTED. FINISHED. FUTILITY. NO MORE. IN THE COMPANY'S OWN WORDS. 100% MYTH that it is somehow still continuing??? The company even "thanked" (as in PAST TENSE USE OF WORDING) the families that "participated" (again PAST TENSE worded) and are NO LONGER PARTICIPATING, as the trial is OVER. DONE. STOPPED. FINISHED. FUTILITY.

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=957281

QUOTING FROM PEREGRINE:

"February 25, 2016
Peregrine Pharmaceuticals Provides Update on Phase III SUNRISE Trial of Bavituximab
Conference Call With Management Scheduled for 4:30 p.m. Eastern Time
TUSTIN, Calif., Feb. 25, 2016 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced that it is discontinuing the company's Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The decision to stop the trial was based on the recommendation of the study's Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis performed after 33% of targeted overall events (patient deaths) in the study were reached. Results of the analysis demonstrated that the bavituximab plus docetaxel group did not show a sufficient improvement in overall survival as compared to the docetaxel group to warrant continuation of the study. The interim analysis showed that the bavituximab combination group is performing as expected according to the original trial assumptions in terms of overall survival, while the docetaxel group is dramatically outperforming overall survival expectations based on the original trial assumptions and as compared to recently published studies.
"Let me start by taking this opportunity to thank all of the patients, their families, and the physicians who participated in the SUNRISE trial. While we are deeply disappointed by this early outcome from the SUNRISE trial, we plan to take a deliberate and detailed approach in reviewing and verifying all available data from the trial in order to understand what subgroups or other patient characteristics may have impacted the performance of the study. While we perform this analysis, we plan to put our other chemotherapy combination studies on hold until we have a clear understanding of the SUNRISE study results," said Steven W. King, president and chief executive officer of Peregrine. "While this is an unexpected and disappointing setback for the bavituximab chemotherapy combination clinical program, ....."

DISCONTINUING = OVER. NOT "on going" in any way.

"Let me start by taking this opportunity to thank all of the patients, their families, and the physicians who participated in the SUNRISE trial." =

Use of word "participated", a word being used in the PAST TENSE, as in, the "trial" is OVER. FINISHED. DONE. NO MORE.

Total BS IMO to "try" and implicate this trial is on-going. TOTAL NONSENSE to me.

[vinmantoo]

"a failed phase III"? Study is continuing or ongoing, not recruiting more participants. Ethics requires following those who have not evented or otherwise disappeared.

The Sunrise trial is as dead as can be. PPHM can continue to monitor those who were treated in the trial, and people who were treated with Bavi were given the option to continue being treated. That is it. The trial is, dead, dead, dead. This is basic biotech investing 101 so any failure to accept that reality is very telling.
Whether or not you feel than Bavi has some life left in it as part of some immune modulation combination is a completely separate issue.

[north40000]

Vin, continue on to read my later response to goodplenty. That response lays out in more detail why the Sunrise clinical study is continuing. What may turn up as a result is totally unknown to me...with that proposition I totally agree with you. I also agree that Bavituximab's role in I-O therapy is a matter of further experimental work with PPHM's collaborator's--- AZN, MSK, NCCN, etc. It remains a separate issue for now.