An observation I had about OGXI in this EXEL debate is that most analysts / bloggers / investors etc. dont know about OGXI. Not many knows that OGXI has a trial as pain palliation endpoint. It's not even listed among companies in the crpc space. Most of the EXEL articles/research notes/bboard discussions are focused on whether pain is a valid endpoint and FDA not signing on SPAs with pain endpoints. I havent seen anyone discussing why OGXI got one but EXEL (except for a comment in investorshub) did not. Most people miss why FDA gave hard time to EXEL even though FDA listed 4 specific reasons for not signing off. This is another evidence that points to how uninformed some analysts/bloggers/investors are.
Although I haven't followed EXEL closely it was my impression that they wanted to make the pain trial, with pain reduction and bone met response as the primary endpoints, their registration trial. That is, if they succeeded, they could get approval without showing improved overall survival. As I read the FDA's comments it was uncomfortable with that. EXEL says it will go ahead with the pain trial without an SPA but will also initiate an overall survival trial early in 2012. If the pain trial succeeds but the OS trial fails I think EXEL's approval prospects will be dim.
In OGXI's case, they have SPAs for both the pain and OS trials and they announced awhile ago that the FDA has told them that success in the OS trial alone would suffice for approval. They've never said the same thing about success in the pain trial alone. As we've heard so often the FDA considers OS the "gold standard" in cancer trials and apparently is reluctant to commit to approving based on a pain endpoint. I admit the value of OGXI's SPA in the pain trial seems murky. Maybe it just means they'd get a broader label if they succeed in both trials, but success in the OS trial is still a prerequisite to approval.
EXEL's setback may be a positive for OGXI. I was a little concerned that if EXEL could initiate a P3 registration trial based solely on pain and bone mets in late 2011 it could potentially finish it before OGXI finishes its OS trial. Then, assuming EXEL succeeded, you'd have yet another prostate treatment on the market that works without chemo, and in this case it would be one that steals some of OGXI's thunder as a pain reliever.
EXEL's pps has dropped in the aftermarket from about $7.80 to $5, but even at $5 its market cap is over $600 million. Under the current circumstances either EXEL is still way overvalued or OGXI is way undervalued or both. (Of course, I'm not taking into account other potential indications for EXEL's drug, relative cash positions, or other factors I don't know much about.)
I just listened to EXEL CC. It confirms most of your observations.
I get the sense that EXEL's timeline will be similar to OGXI's timeline even it had the SPA. The CC confirmed that the pain palliation trial (306) will be slower to recruit (less number of patients) but quick to evaluate. The OS trial (307) will be faster to recruit but larger and slower to get a readout.
Using the recent excitement, EXEL was able to raise good amount of cash and is much richer than OGXI. However, I agree with your point about discrepancy in the evaluations.
We need to figure out if the OGXI's SPA will allow filing based on pain palliation study alone. I always assumed that it can. So I was not too happy to hear the points raised in the EXEL CC.