The disadvantage of not wearing a speedo it water is that you have large empty pockets to pull you under with the tide.
Expectations of 2 P3 restults. The FDA pulled their priority status based on another drug being better and approved. Or somehting along those lines where it's likely not to be appoved but there is a second P3 trial to bank on which I would not touch until I did a lot of due diligence on it. It's a first in class drug and looking at first in class drugs is more tedious than follow on compounds like Cabo where there is a lot of literature around it with human dosing. You really need to dig into P2 results and tear it apart and really know the biology around it. So for me, it's currently easier to stay away from it.
The NCI is not funded by BMY or EXEL; but a independent 3rd party with a lot of money to fund trials that companies would otherwise not do. The fact the trial is happening does not mean they've made any connection other than agreeing to supply the NCI with the drug.
They could be co-dosed without a collaboration between the two.
Just glancing at it, I have to go with semanresu. Short it. You'd be banking on recaparib and it's first in class which tricky since it could be helpful or hurtful for approval.
The P2 results would really need to be the driver here. One should really look at the molecule too, the structure itself has a few red flags from a med chem perspective but the details would have be examined in context of what the treatment is.
For me, I'll just say that there are better things for me to spend my time with other than CLVS.
I wasn't saying you're wrong because Gefitinib is modeled electronically to mimic ATP to some extent and does bind at the ATP binding site (perhaps modeled only in restrospect). I was just saying one really doesn't know without crystal structures because it can be competitive without binding to the actual site. It just has to inhibit binding of ATP while it's bound.
Orphan sites cannot be eliminated as whole and have to be taken individually.
Gefitinib stabilizes the EGFR homodimer, inhibits receptor phosphorylation and is dimerization dependent in order to modulate it.
Revenue should be building over 2016 for cobi and 2017 for Cabo.
You could make an argument over profits with income over expenditures such as debt but revenue almost definitely will be increasing next year.
Did they say anything else? That's a long time to be paying bits of cash for a preclinical program with nothing in humans.
From where I sit, it looks like hush money while they work around any patent.
" It is not an impediment of any appreciable magnitude."
Assuming the approval of Cabo for RCC with no strings attached, I agree. With Cobi alone, it would be.
The 3rd quarter financials did mention that outside of Cobimetinib, $2.3 billion in the aggregate on a non-risk adjusted basis, of which 10% are related to clinical development milestones, 42% are related to regulatory milestones and 48% are related to commercial milestones, all to be achieved by the various licensees, which may not be paid, if at all, until certain conditions are met.
So, there is appearently $230 Million in potential milestones contained within some of these trial partnerships. I personally suspect that some of them are on hold but can't say for sure.
I don't. I suspect their presentation will be run of the mill; potentially to turn the coals for a possible JV partner. If anyone gets new information it will be the partner in late stage agreements.
The application should be "fully submitted". The "Rolling" part just indicates that they get priority treatment for the review so they'll get asked more quickly for additional data if needed. Instead of like Cobi where it was extended PFUDA date at the request of additional data. The other benefit is that they can immediate apply for labeling approval instead of waiting until the approval of the NDA.
Much of the market is responding to the fear of a fed rate hike more so that fundamentals of any particular company.
IMO, the feds don't have the room to move but it does not prevent them from doing something stupid like actually raise the rates without a balanced budget plan in place by Congress.