Format was Q&A which allowed for a little straying from the usual script.
Cormack said the SYNERGY trial design incorporates 1 interim analysis and 2 futility analyses. He refused to say whether any of those had already been done and he said that unless any of them results in stopping the trial, for either futility or efficacy, they don't plan to say anything.
He said that if SYNERGY were to fail they would expect to continue the other P3 trials for 011, AFFINITY and ENSPIRIT. He said Teva is contractually obligated to do so unless a safety issue shows up or there is a patent problem.
With respect to 427, he said the hope is that if Borealis-1 and/or Borealis-2 produce solidly positive results they could file for approval without doing a P3 trial. If the FDA didn't agree then "at worst" they would be supportive for a P3. (My take: given the few options for bladder patients and the minimal progress over recent decades, and the fact that the second-line patients who are the subject of Borealis-2 typically live only about 6 months, the FDA is likely to be accommodating.)
He said they aren't looking to partner 427 at this time although they always maintain lines of communication with potential partners. Perhaps they'll partner when they have more randomized P2 data, but he said that if SYNERGY succeeds the milestones and royalties they'll get from Teva would allow them to take 427 further on their own.
All of this makes me wonder about the low pps. If SYNERGY were to succeed it would dramatically raise expectations for the other 011 P3 trials and also help validate 427, and the milestones etc. would help pay for the 427 trials without further dilution. In that scenario, it would seem the market cap should be several times what it is now. Is the market assuming SYNERGY will fail, or is it just not paying attention to OGXI? It would seem that 427 alone justifies the current market cap (though obviously if SYNERGY were to fail they'd have to do another financing at a presumably lower pps so maybe the fear of that scenario is what's holding down the pps).
I received one of those "activity on your posts" emails from Yahoo this morning notifying me that jd9919 had replied to this post, with an interesting analysis of how the market perceives the odds on SYNERGY and why OGXI's pps is depressed. Even though I was able to read it it doesn't seem to be visible on the board. I tried posting it myself but that didn't work so I emailed Yahoo back to complain. We'll see if this message shows up. What a brilliant new MB system they've come up with!
Best post here in a long while. The mkt action with this name has been interesting to say the least. Shorty has been using every decline in this name to reduce exposure shorty (which is just my name for the short selling and hedge fund community) has been typically VERY precient in major price moves with bio techs and almost never wrong in the prostate space. I have seen no analysis of probability of the Synergy trial failure or success only commentary regarding a lack of excitement over Synergy . The lack of excitement I believe involves the potential size of the mkt for CRPC rather than the outcome of the trial. The new treatments from JNJ and MDVN would lead one to believe that the share of mkt would be smaller than the one that resulted in a $40.00 price on OGXI
Here we go again. The subject line for this thread says the last message is by Summer, who hasn't posted in awhile and whom I'm sure we all miss since she was the most knowledgeable poster here. But as far as i can tell her message doesn't actually appear. I think today's Yahoo format change is a slight improvement but if they still can't stop screening out messages without explaining why they've got a long way to go.
Summer, is it possible for you to try reposting, maybe as a new topic?
I was able to read Summer's post because it appeared in this morning's email from Yahoo on "recent activity on your posts." I'm pretty sure the Yahoo gnomes censored her because she included a link, and as we know Yahoo allows only spammers to provide links.
I'll try to paraphrase what she said. She didn't agree with Cormack's comment in the Leerink cc that if SYNERGY fails Teva would be contractually obligated to continue the AFFINITY and ENSPIRIT trials unless there was a safety or patent issue. She noted that Teva also has the right to terminate the collaboration agreement for "futility" as defined therein. She is still looking into the definition. But she said that regardless, if SYNERGY fails Teva will probably find a way out of completing the other trials.
I tend to agree. If Teva can't find a contractual out, they'll probably negotiate a settlement with OGXI that would still cost them a lot less than completing all the trials. It's my impression that if SYNERGY fails, the FDA would likely insist on a higher statistical bar for the other trials -- maybe p
Summer posted yesterday and included a link which unfortunately is verboten in the new Yahoo. I think there are others here besides me who are interested in what she has to say so I'll try to repost it without the link:
I dont know what yahoo is thinking with this new bboard design. On top of all those issues, having only 2 lines to type a response is quite funny in this day and age.
Other reasons I dont post anymore is because first yahoo removed RSS links from the bboards (my rss reader does not warn me that there is a new post here). By the time I remember to use the browser to check what's happening here, I usually miss the discussion. Second I dont have much to add.
From what's posted on other bboars and twitter is that most investors expect the SYNERGY trial to fail. I also see that OGX-427 is generating excitement but investors think the best time to invest is after the SYNERGY fails.
The co is not helping by being silent about the futility analysis & interim. A PR that the co passed the futility would not harm.
Also, the MOS is now above 21m. [This is where she provided a link.] This 21-month median overall survival is before the newly approved drugs were fully used by all the patients. If this trial were to be repeated today, we might even see a median overall survival of 24+ months. The control arm in the SYNERGY trial might end up having MOS 22 or 23 months. This makes the trial less likely to succeed just from a statistical stand point. That's really unfortunate because in few years, zytiga and most probably MDV-3100 will be used before chemo.