Replies to post #110286 on Avid Bioservices Inc (CDMO)

[investingdog]

<< BioBS2012 The ONTY/Stimuvax story as I remember it: ... the trial failed >>

Almost unbelievable. Why did it fail? Placebo arm living longer for some unexplained reason, labeling mixup or something else?

[bimerkjaere]

I understand the importance of the Stimuvax example as it shows one that just because a trial is lasting longer than expected, this doesn't always equate to longer survival for the treatment arm.

However, I would say Stimuvax's target patient group differs from bavituximab in that Stimuvax’s NSCLC patients had stage III stable disease, with an expected MOS of somewhere between 25 - 33 months. The literature shows significant variance in MOS depending on baseline characteristics (e.g. ECOG score).

With stage III-IV locally advanced or metastatic, untreated NSCLC, you have much lower expected survial times. Carboplatin+paclitaxel in the ECOG trial (2002) showed a MOS of 8.1 months. In the Avastin Phase III trial, C+P control had a MOS of 10.3 months and C+P+Avastin has 12.3 months MOS. Differences in the ECOG C+P and control C+P in Avastin trial could have been attributable to better ECOG PS scores in Avastin trial (40/60) vs. ECOG trial (28/67/5) and a greater % of women in Avastin (50/50) vs. ECOG trial (42/58), as women had longer MOS times in both trials.

Either way, the main point is that bavi’s treatment population in the 1st-line NSCLC trial, is stage IIIB-IV with locally advanced or metastatic disease, a more advanced patient group with lower expected survival times and thus lower chance of variance in MOS output. In other words, this means that the control group is much less likely to produce a much higher MOS than its historical averages. With bavi’s 1st-line trial being extended by multiple months, and using the enrollment completion date of Sept 2011, we are much safer in assuming it is bavi extending the survival compared to the C+P control group (we could be looking at a >18month MOS readout in this trial if reported in Q213) than those investors of Oncothyreon in Stimuvax.

IMO

[BioBS2012]

Just re-posting an old post as a cautionary tale.
FWIW - I have complete confidence in SUNRISE meeting its primary and secondary end-points.

OT - Request the Board Police to Keep this post  
  DISCLAIMER: This is not intended to offend anyone, nor is it directed at any specific individuals. It is a post made on another board that I found would be worth reading for everyone. What conclusions you draw from it is entirely up to you...GLTA  
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  ONTY/Stimuvax -- any apples here?  
  The ONTY/Stimuvax story as I remember it:  
  
  Phase 2 looked good and MRK.de took it into large phase 3 trials spending $100s million. They would not do that if they were not very confident in success, right?  
  
  Very knowledgeable posters on the message boards (yahoo mostly) reversed engineered enrollment curves so that overall survival could be compared to known past standard of care treatments. Very convincing work -- critiqued and modified many times until we had it all just right.  
  
  Every past study was sliced and diced so that we could all be sure that what we were seeing in the over-all population was exceptional, thus it could only be the Stimuvax causing the trial to go way past what was expected.  
  
  The study design, very professionally done btw by an experienced MRK.de team, had triggers based on number of deaths. The trials went on-and-on with no trigger so we knew overall survival was spectacular for this trial. Unprecedented really, and even after the numbers were sliced and diced using the most conservative of models the Stimuvax arm had to be doing many months better than standard of care. Success is a lock.  
  
  Interim looks went by without a hitch, some concern why the trials did not stop for efficacy there, but we are pretty sure MRK.de designed it so that it would have to have overwhelming numbers for a stop. Anyway, it was not stopped for futility so we know something must be right!  
  
  One poster on the board was a scientist on the team that originally developed Stimuvax so we benefited from his vast knowledge about all things Stimuvax including method of action, what to expect about 'curve separation' etc. Hell, practically inside information.  
  
  One poster was a >5% holder of the stock which we could all verify by SEC documents. Great track record, had researched it carefully before investing, so how could we go wrong following his lead.  
  
  Other posters, it seems, dedicated most of their waking hours checking every last nuance and assumption and declared we have a winner here.  
  
  We knew through medical message boards and friends-of-friends about people in the trial who have now lived over 5 years! Unheard of in this indication. Must be Stimuvax.  
  
  During these phase 3 trials MRK.de started several other trials with Stimuvax in other indications. They would never do this unless they knew it was working right?  
  
  Oh, and we had evil doubters like a hedge-scum dude named Feuerstein and message board posters who only had negative things to say -- obviously just shorts trying to scare us out of our shares. Nothing like enemies to get a group circling the wagons which was followed by a long circle jerk inside a bubble of our own making while we waited on results.  
  
  The trial failed.  
  
  -bin  
  
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