Like the NSCLC & Saturn trials, the CC was delayed as well. Not too many analysts. (e.g., Mark Monane was missing).
>During discussions regarding the SATURN Special Protocol Assessment, or SPA, amendment, FDA stated that an application supported primarily by the results of SYNERGY alone would be acceptable for submission.
Very confusing. Because of the existing SPA, I always assumed that one trial is sufficient for submission. Dont we have an SPA? What does this mean?
Delay in NSCLC trial: TEVA dragging its feet until the SYNERGY trial is complete not to risk money unnecessarily?
SATURN: This is confusing as well. While we were at it, why not extend the protocol for abiraterone as well?
I'm actually happy that this trial may/will complete after the first line trial at least after the interim analysis.
SYNERGY: Still on track. That's good news. And that's the only news that matter actually. The interim will be probably Q4 2012 or Q1 2013.
How low will we go? I dont know. I will slowly and systematically continue to accumulate for the next 18months.
Summer, you probably know more about this than I but I think at one time not long ago the FDA used to require success in two trials for marketing approval of a new oncology drug. Doesn't make sense to me -- if SYNERGY succeeds and SATURN fails, it should just mean you get a label that says the drug extends survival in first-line patients and don't get a label that says it reduces pain in second-line patients. And apparently it's now settled that that's what would happen.
The delay in the NSCLC trial was a real downer, since the lung cancer indication was undoubtedly built into the valuation. Especially since the prostate space is now filled with so many new non-chemo-based treatments, I thought initiation of the lung trial would give the pps a nice boost. I certainly hope Teva isn't planning to delay its start all the way until they get results (even interim results) in the SYNERGY trial, but Cormack was awfully vague as to how long the delay might be and neither of the questioners asked. The fact that they're still running studies and considering a range of chemo drugs makes it sound like we're in for a significant wait. Then again, maybe we'll be pleasantly surprised and it will all be resolved by the next CC.
I agree it would have been nice if they could have expanded the SATURN protocol to include patients who are opting for abiraterone instead of another round of chemo. They've certainly talked about how preclinically OGX-011 enhances hormone ablation treatments. Maybe getting approval for abiraterone in the second-line setting would have required a preliminary clinical trial or two, since whereas Cabazitaxel and Docetaxel are both taxanes abiraterone is a very different animal. But I think if Teva would greenlight some sort of study combining 011 with abiraterone it would really wake up the stock.
I found it interesting that he kept saying that trial timeline guidance was either changed or unchanged from previous guidance. I've listened to all the CCs since OGXI went public in 2008 and don't remember any guidance, except in the last CC for the bladder trial involving 427 as monotherapy.
Many questions were left unanswered, especially about the status of the lung trial. With few analysts participating and no IR department it may be awhile before we get answers.