Avid Bioservices Inc (CDMO)

[BioBS2012]

You completely miss the point. PPHM made a statement at the time the trial was stopped. They either had numbers at THAT time, or were BSing and trying to spin.

Not sure why you are being so persistent in demanding that PPHM release data or that they are spinning SUNRISE. They stopped SUNRISE at the recommendation of the IDMC based on data from the 1st INTERIM look-in. DO you have difficulty with understanding what INTERIM implies? What the #'s were at the INTERIM look-in is IRRELEVANT at this point. The study did not meet its intended end-points - end of that story. They said they will do an in-depth analysis of the data that continues to accrue and that they will release the findings as and when the analysis is COMPLETED.
The only spin seems to be coming from your end that PPHM is somehow trying to spin SUNRISE. They have done nothing of the sort. Below are excerpts from the PPHM and BMY PR's related to the SUNRISE and CHECKMATE-26 studies respectively. You can spin it however you want, but most people will notice that the two PR's are essentially the SAME !!!!

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, we have not seen anything in this trial result that diminishes our enthusiasm for advancing our immuno-oncology (I-O) combination trials. The I-O combination studies are based on different mechanistic synergies that are clearly separate from the chemotherapy combination being evaluated in the SUNRISE study. In addition, it is important to note that in no way do these results have any impact on our contract manufacturing business conducted through our wholly owned subsidiary, Avid Bioservices. This business has shown consistent revenue growth and has been instrumental in maintaining a strong cash position and our plan is to continue growing this business."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that CheckMate -026, a trial investigating the use of Opdivo (nivolumab) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ≥ 5%. The company will complete a full evaluation of the CheckMate -026 data and work with investigators on the future presentation of the results.

Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb, commented, “Opdivo has become a foundational treatment that is transforming cancer care across multiple tumor types. While we are disappointed CheckMate -026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase 3 CheckMate -227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”

Both acknowledge the failure of their studies respectively and seem to send the message that combinations are where the future is, in their own respective way.

Cheers.