I/we can find excuses why the the pps is as this level and how clever we are compared to everyone else who do not see the value in OGXI. I can deal/balance such ego. However, I cannot deal/balance my fear that someone has more info than we do and we are not so clever anyway.
The bottom line is that OGXI has 3 phase III trials and 6(?) randomized Phase II trials. The management has some explaining to do why the pps is way below the comparable companies.
I do not think DMC told or hinted about HR to TEVA or OGXI. Otherwise, Teva would not have started the qt study or would have already fizzled out. They had the perfect opportunity because of the reorg.
Re: website: I see what you say but I still think starting the qt study now is more positive than the website. The cost of the website is probably 1/1000th (or less) the cost of the qt study. If TEVA wanted out, it would not use qt as an excuse. The cost of running these studies another year must be way more than the penalty of getting out.
The dilution may already have occurred via the ATM. No regulatory filing is needed if used, but the subject would come up on the conference call. I was hoping they'd wait for some good news before using it, but the way the price has been dropping, I wouldn't be surprised if management raised some capital now (in case the slide continues.)
That leak theory is scary stuff. There were plenty of other events, however, which coincided with the stock price's multiple legs down:
- Announcement of CFO's departure (along with her severance)
- Announcement of new 427 trials (good news but a use of cash)
- Announcement of ATM facility (necessary but still a dilution)
- Announcement of Xtandi results (uncertainty about changes to prostate cancer landscape)
- Controversial SNTA hsp90 results
In the same time span, the only good news we got was the Needham upgrade. Had the upgrade come from a more credible source, it might have served as an offset.
I think we see a financing before the conference call. By the size of the drop in share price its going to be a substantial one. The Needham upgrade, increased volume, its textbook stuff! I'd say 10 to 12M at $6.50. The market is expecting it and they need to get it done soon. IMO once done we will see the price rise into results.
If correct this will probably signal that it didn't hit on efficacy interim.
I'm not one to dismiss the possibility of a leak in an open label trial but wouldn't a leak of the interim futility HR have had to come directly from the DSMB? That is, the DSMB wouldn't have provided it to Teva or OGXI, right? It would just have told them the futility threshold was met. It seems unlikely that the DSMB would leak to anyone, though I suppose you never know.
Teva could have wanted to do the QT trial early because if there is a safety problem with 011 it would want to stop the AFFINITY and ENSPIRIT trials as soon as possible. Under the partnership deal, it can cancel a trial without penalty for safety reasons. So its motivation could be a good sign (it's optimistic about the result of SYNERGY and wants to have a complete package for submission to the FDA), bad (see previous sentence), or none of the above -- it's just being conscientious.
Back to the leak issue: I remember that when SNUS, the company into which OGXI reverse merged in 2008, had its P3 implode in September 2007, the outcome was (in retrospect) foreshadowed by the fact that its partner Bayer didn't mention the SNUS drug in Bayer's discussion of its pipeline in its annual report in the summer of 2007. I suppose that could have been a coincidence but I know SNUS IR said at the time that SNUS was miffed. That's why I was somewhat heartened that Teva has set up a website promoting 011.
Summer, we have no idea what the event thresholds were for the futility looks, right? I was guessing 33.3%, 66.7% for futility, and 75% or 80% for efficacy.
The second futility look being passed should insinuate SOME level of efficacy (p
This qt/qtc requirement is new (~7yrs).
Not being able to post links is terrible.
Google for abiraterone and qt (First link).
For enzalutamide and qt. I think it's the 5th link.
Cabazitaxel qt. Second.
No way there was a leak! It's just that Medivation had some good numbers and they got the applause and adulation.
Hopefully, Cormack has good things to say on the 7th of November.
Summer, I've never seen this before in a later-stage oncology trial, maybe I don't get around enough. I looks to me like a non-SUSAR level heart-related safety concern was identified at the futility analysis, and they (or they and the FDA) decided they better test it since it can be tested quickly (i.e. before final SYNERGY results are out).
Right? In the absence of a leak of an interim HR, I would see this as mildly positive. Too hopeful?
qt/qtc studies are pretty much required by FDA for all new drugs. In oncology, it's a little bit more relaxed compared to others. If HR is good, even considerable QT prolongation may be acceptable. Notice that TEVA started the qt/qtc study after Synergy's futility analysis.
The website is not a big deal. It is inexpensive to create a website compared to conducting clinical studies. Starting QT study now is a better indication of the commitment than the website.
I dont think TEVA officially thinks that the trial is doomed. It's an open label study. A leak is a more plausible explanation for the drop (~50% in one year) in the pps we witnessed. The start of the drop coincides with the futility analysis. So my fear is that the interim futility HR has been somehow leaked.
Summer, do you know why Teva is conducting the P1 Qt study you mentioned? The part of your original censored post that appeared in my email from Yahoo before their gremlins cut it off read "FDA nowadays requi..." which leads me to think you were going to say the study is a new FDA requirement and isn't due to any problems that are specific to 011.
Also, do you know when the Teva exploremerit site that's about 011 went up? The date at the bottom of all the webpages is October 2013. If that's when they created it it suggests that Teva is either optimistic about SYNERGY or has no information about the outcome one way or the other. In other words, if they had info that the trial is doomed you'd think they wouldn't bother. And if Teva has no such info then whoever has been selling off OGXI probably doesn't either.
you mean $3. this pos is hitting the skids ! why should it stay overpriced at $5?
Thanks for the effort. I dont understand what Yahoo is trying to do. I even removed all the links from the message before posting. And it still did not like something in that post.
My point was that even though it seems like everyone gave up on Synergy, TEVA does yet seem to share the same conviction.
Will try again quickly. The Teva website discussing 011 is exploremerit. You can find the new P1 trial by Googling custirsen repolarization.
Summer, I got an email from Yahoo with snippets from your post about how Teva has put some effort into marketing 011 already and has started a new P1 trial but I've tried repeatedly to post and Yahoo won't let me include any substance. Am rushed now but will try again later today.