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Why the F would you start coverage for a company that you think will lose its main revenue stream in ~4 months????
Exactly! (eom)
Hiring:
ARIA:
camptosar?
OT:
MNTA:
For the sake of clarification, can the legal types clarify the ease with which a preliminary injunction is or is not granted?
In other words, is it automatic or does it require deliberation on the part of the court?
ONXX:
I figure it's worth pointing out to readers that ONXX appears to be following the path that MLNM did for Velcade. Try to get approval through a single agent trial and have a controlled trial in an earlier setting underway to satisfy the accelerated approval requirements.
It worked quite well for MLNM.
ONXX:
ONXX:
It doesn't have to be in exactly the same setting.
ONXX:
OT:
OT:
>how are corporations different from individuals in this regard?<
Ethically no different if they use the same loopholes with the explicit purpose of shielding income and/or receiving undue breaks*. I only used corporations as the example because that is what Imclonian started with.
But I suspect that for the majority of chumps like me, Turbo Tax doesn't offer the "Hide your income in a low tax municipality by upgrading to Turbo Tax Platinum" option just yet.
*The tax breaks people got years ago for buying Hummers was one of those ridiculous cases of individuals rummaging around for undeserved tax benefits.
OT:
OT:
OT:
The Ariad situation with the survival data will be interesting in that the investment community appears to be of the position that a lack of benefit will doom the application.
Obviously the survival data showing that rida harms would be a deal breaker, but I've been unable to get a good bearing on what are acceptable results. From an FDA point of view, there is an SPA issue (although TFCDWIW: the FDA can do whatever it wants) as well as the fact that the survival data are now being accumulated in an open-label fashion.
I know Dew threw around the HR ~ 0.85 threshold (if i remember correctly). At first glance that sounds reasonable, but I wonder if the FDA will necessitate a higher mental threshold just due to the open label nature of the study.
I'm not sure that there is any reason to be jazzed up about ponatinib at ASCO. The trial is ongoing and you're not going to get any concrete data. It'll just be a time for those who strain to find nuance in Harvey's voice, breathing and words per minute usage.
Registration trials:
I think there are reasonable questions to ask about ARIA's rida trial. But more generally I guess I'm not totally clear on this point:
Pancreatic. eom.
Re: T315i subset
I got a little overenthusiastic about this subset as well, but if you noted biomaven's posts on the values board, this isn't really gonna fly. I think we just need to be patient and let the trial go to completion.
CYTK:
CYTK
Tony:
I did not mean to bore the board with a discussion of what we think the b-adrenergic receptors are doing. I think my main point in that post is that the CYTK drug is trying to increase contractility / force output from the heart, which usually makes things worse in animal models.
>Ariad will be on the market much sooner with much better results............and I dont even know what those results are.<
Despite my disinterest in THLD, this is a really dumb thing to say.
> that IRC radiologists were more likely to interpret small tumor size increases(possibly due to inflamation associated with regression)as a sign of progression, versus the locals, who may have access to a wider range of interpretive measures? <
Well, you can measure things on a CT scan and the criteria for progression are based on percent increases in length and/or area o the lesion from one scan to a subsequent scan that is usually at least a month later.
So if I'm understanding you correctly, it's important to note that the radiologist does not have discretion over what percent of increase constitutes progression. In other words, one guy can't say "well, for me that little increase is a big deal" with the other saying "i don't think that little increase is a big deal."
There are cutoffs for percent change from scan to scan that the assessments need to abide by in order to declare that progression has or has not occurred.
If I was a betting man, I'd say it is mostly due to the inherent bias when the people on site are reading the scans. But also see the possible cause for discrepancy cited by biomaven in post 112748.
Note that these ambiguities are based on different people reading the same scan. So it's not a question of the people on site having one CT scan to look at and those at the central review looking at another one of different quality. It really comes down to how the viewer assesses the situation.
Since both analyses in the rida trial yielded strong p values, I don't think we're in trouble here. Also note that the Hazard Ratio changes little from the central to the investigative site analysis despite the relatively large shift in the rida arm's median PFS. This HR is a more thorough analysis that suggests the difference between the curves over the duration of the trial is relatively constant despite where the median events occur in these two analyses. This also suggests to me that the majority of the separation between the curves is happening later on during the trial* so there may be merit to the idea that a subset is really pulling the curves apart at later points.
* This isn't overly insightful given the short duration to median PFS, but it's still important when trying to visualize what these curves look like. I suspect that when we eventually see them we won't be overwhelmed by how far apart the curves are right at the median.
>Can one of the scientists on the board please explain how this company could be selling these drugs, prior to approval by the FDA?<
We get access to plenty of unapproved drugs for research use. We just promise the FDA that we won't feed them to humans and it's ok.