Replies to post #310284 on Avid Bioservices Inc (CDMO)

[peregr]

The control arm was a placebo. I don't think that is the comparison we want to use for Bavituximab.

[bfiest]

And their BOD and management team gave out bonuses, doled out more options and increased their pay after thirty years of losing efforts. We all know that drugs fail. Are we masking the real issue?

[BioBS2012]

For added perspective, folks, you might glance at OTIC this morning... It reported failure in a late stage P 3 trial for Meniere's Disease, promptly lost 80% of its market cap in PM. Control arm performed unexpectedly better in the trial.

PPHM is not alone.

OK, I will bite. The similarity to PPHM IMO is that they took resuts of a failed Phase II study. Sliced and diced it to comeup with subsets that showed statistically meaningful differences -prospectively. Than ran a Phase III that was probably doomed to failure before even starting. JMO.

In May 2015, we announced results from a Phase 2b trial evaluating OTIVIDEX in 154 patients with unilateral Ménière’s disease. The primary endpoint of the trial was reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. In the topline analysis, OTIVIDEX demonstrated a 61% reduction from baseline in vertigo frequency in Month 3 vs. 43% for placebo with a p value of 0.067, which narrowly missed achieving statistical significance. The trial achieved statistical significance (p < 0.05) for multiple prospectively defined secondary vertigo endpoints at multiple time points including the count of Definitive Vertigo Days (DVD) by Poisson Regression analysis that achieved statistical significance in both Month 3 (p = 0.030) and Month 2 (p = 0.035). Based on these results, and discussions with the FDA during an End-of-Phase 2 meeting, we are conducting two parallel Phase 3 trials in Ménière’s disease using count of DVD by Poisson Regression analysis during Month 3 as the primary endpoint. AVERTS-1 (Alleviation of Vertigo Episodes Study) is the Phase 3 trial ongoing in the United States while an identical second trial called AVERTS-2 is ongoing in Europe. Results of AVERTS-1 are expected in September 2017 and results of AVERTS-2 are expected by the end of 2017. Patients completing the Phase 3 trials have the opportunity to enroll in an open label safety study and receive two quarterly doses of OTIVIDEX.

http://www.otonomy.com/pipeline/otividex/

The OTIC Phase III failed MISERABLY. Just look at the p=values
Primary endpoint p=0.62
Secondary endpoints p=0.99 ; p=0.93 ; p=0.81 OUCH !!

https://finance.yahoo.com/news/otonomy-reports-results-averts-1-110000876.html

I don't think the above could be classified as a higher than expected performance of control arm. As in the words of a wiseman, the OTIC drug is a PLACEBO !!