Maybe FMR was done selling but bought it back. (add a smiley here as I do not think that's what happened).
So the mystery deepens. Who's selling? What did TEVA do with its shares?
Bioprogene said in a post yesterday that OGXI's comments on this were made in the Wedbush presentation on August 14, which is still archived on the website. About 4 minutes in Scott says that they originally estimated they'd reach the number of death events for the final around the end of 2013 based on about 21 months for the controls and about 28 for the treatment group and that that comes "on a blended basis to about 24-25." He then says that they now realize that patients are living longer than expected so they're pushing out the estimate to the end of Q1 or the beginning of Q2.
Thanks. I'll relisten. I remember some math at the start of the presentation but I think when I heard 21m estimate, I must have discarded the rest.
Stifel has a point. The co needs to communicate the new reality better.
If the analysts are still convinced that Synergy can be a success, their target calculation math must be wrong.
I don't they ever said anything precise in one spot. I read a transcript where the McCormack discusses how they came up with 21 and 28, and more than one where they guide the end of 2013 (and where they say events have slowed and guidance is pushed out).
But nothing talking about a blended median -- it's simply implicit in the other guidance. The blended expected median has to be very close to 24.5, because that's half of 21+28.
"Unless, there is a math/data error above, I think FMR is done or about to be done."
Fidelity was not done selling. It's not that you made a mathematical error or that your data was incorrect. It was your assumption that was flawed (even though I got thumbs down for pointing it out at the time.) I do not rejoice in the bad news, and hope Fidelity doesn't know something we don't.
On 6/30/13, Fidelity had 461,529 shares
On 9/30/13, Fidelity had 219, 196 shares (according to data posted at the "whalewisdom" web site)
Total shares sold in 3Q: 242,333
Percent share reduction: 52.5%
Stifel …increased risk premium for P3 custirsen data due to increasing difficulty of demonstrating statistically significant OS benefit in an indication where an increasingly number of active post chemo treatment options are now available.
Meanwhile Blair assigns 65% probability of success to SYNERGY
Needham says conviction remains high for positive data
Cohn Brothers: 100% chance of another oscar.
They went in yesterday to update the enrollment count to a precise 1023 -- and that's it.
Wonder what would have spurred that sudden desire for precision.....
"In earlier presentations (after Q2) the CEO stated that if the overall median (blended from 21 and 28) is 24~25 months, the target event would be reached near the end of 2013."
I might have missed this one. Do you remember when? Not that yahoo would allow any references to be posted, but do you have a reference?
I should watch that movie again. I've seen it but I don't think I could have gotten it without your cue.
Yes. in the next 6months, we'll need the luck. Have a safe trip.
Looks like it's just a sector related move.
Nothing company specific on most of these bio's, and they all seem to move up and down as a group.
Oh that's the Big Lebowsky. in case you are wondering about the pee on the carpet reference. but I think you get it Summer, if I remember you're from California. Good luck, we need it over the next six months. Stephen
Hi Summer, I am engaged in some out of town work for a bit, but will ask for the report and let you know. As you might guess, while I am not selling anything, this stock is becoming a pain in the …. I find myself resorting to the philosophy of the Dude, the principle of non-action. I hardly watch the daily action or care about it. But if anyone pees on my carpet, things will change. Stephen
Thanks for all the info. In earlier presentations (after Q2) the CEO stated that if the overall median (blended from 21 and 28) is 24~25 months, the target event would be reached near the end of 2013. Now the target event could be reached 3 to 4 months later (end of Q1 or early Q2 of 2014), wouldn't that make the blended median to be about 28 months (CRPC survival curve is close to linear)? I think the control arm could be as high as 25 months, however the treatment arm then should be 31 months.
As for the MOA, I believe clusterin is an immune suppressant (immune evasion of cancer cells). Therefore, suppression of clusterin up-regulates immune response (low levels of clusterin are related to autoimmune diseases as RA, lupus, and psoriasis). In a sense, clusterin is very similar to PD-1, even though they are in different immune pathways. Remember that PD-1 knockout mice develop lupus.
What we don't know is who knows more than we do. Hedge funds have gotten information from doctors prior to public disclosure before. Even if that informaiton is partial, it could be of some value. Otherwise, no matter how sophisticated you are or your models are, you are just plain guessing. I have seen all this before, as have many of you. I admit that I read it for the same reason you read it - you hope you can gain some insight or advantage. But you can't.
For the final there is no decision by DMC. They punt it to FDA to decide. For DMC to unblind the trial early, they need to be sure as there is no turning back. So unless there is overwhelming evidence, DMC wont unblind early. P=0.02 is overwhelming evidence for OS. However, if there is no PFS benefit, I do not know what the DMC would do even though FDA would approve it (see DNDN).
So Summer, you're saying that if the trial isn't stopped at the interim, it could mean they hit the required p-value, which you've estimated at .02, and had acceptable safety data, but missed on secondary endpoints? This is different, I assume, from the standard that would be applied on the final, so the odds there could still be good even without taking into account that the p-value then would be higher.
If the interim falls short, the fact that they've apparently backed away from their guidance of interim results on the Pacific trial of 427 with Zytiga at ASCO-GU in February will be particularly unfortunate because it could have provided a near-term catalyst and pps buffer.
I hear you. I'm just tired being burned by these smaller biotechs, and in addition to everything else, there is the freaking Feuerstein-Ratain rule here as well. We're definitely marching into the wind, the squeaky clean Phase II notwithstanding.
There are many other reasons why a trial will not be stopped at interim. Especially, given the fact that OGX-011 did not do much to the secondary endpoints in the P2 trial.