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EXEL:
Oops, had forgot about the survey...
If it's of interest to the board, then I think the survey could simply be two choices:
a) Cancellation of ODAC is a net positive and cabozantinib will be approved by the PDUFA date.
b) Cancellation of ODAC is a net negative and cabozantinib will not be approved by the PDUFA date.
EXEL:
EXEL:
EXEL:
EXEL:
EXEL:
I would wager it's a positive.
If the application is a mess, EXEL would have been notified earlier / received a refusal to file.
MDVN:
For those who like this sort of thing, they're doing a 2 for 1 stock split. Record date Sept 7, payable date Sept 21.
When societies get stupid:
I've complained about this embargo silliness before, and I think that the actions here are against the spirit of science and medicine:
HFPEF is a very large unmet need. I think earnings in this indication would be meaningful even for big pharma.
Exel
To be more clear, I'm wondering if the medical community will do a better job of finding cabo's role in PC than exel's trials will?
I wasn't thinking there would be a windfall of earnings from off-label use.
EXEL:
One thing the PPHM investors can do is lay out some explicit expectations for the next data release.
What will be success? What will be failure? What endpoint do you expect management to focus on? Do you expect p values and HR or not?
That way you can objectively decide how the released data stack up. Otherwise, it's easy to rationalize the results.
I read both articles referenced in the paragraph you pasted. Neither indicate that cancerous cells escape immune responsiveness due to their expression of PS. Rather, they again indicate how important PS is for recognition of apoptotic cells by phagocytes.
Can you point me to the data in the papers referenced that backs up the disguise claim?
PPHM:
PPHM:
You do realize that the person in charge of production / purification of the antibodies is perfectly described by your paragraph.
You keep insinuating that he lead the whole team and designed the clinical trial strategy.
PPHM:
ONXX:
OT: "esteemed scientists"
Far be it from me to critique anyone's pursuit of science. I've not intention to do so. But I do think there are some relatively objective ways to assess if someone is an esteemed scientist. Copying their bio page is not one of them.
Here are a couple of ways to get started:
http://www.nasonline.org
- search the member directory
http://www.hhmi.org/research/search.html
- enter a name
http://projectreporter.nih.gov/reporter.cfm
- search project investigator
INCY:
I listened to the CC. These are my guesses as to what people are worried / surprised / outraged about:
- the company is being secretive with their exact numbers of patients / new patients per quarter on drug. This type of secrecy isn't all that surprising.
- it does sound like the patients being brought on drug right now tend to strictly follow inclusion criteria as per the label. Obviously, we know analysts hate it when only the on-label patients are receiving drug.
- there aren't 1,000,000 patients with MF. This goes to your point about the drug not bringing in 0.5B of revenue immediately.
- someone outed a super duper secret pipeline drug! Apparently the company has a follow-on compound for MF, and an analyst let the cat out of the bag today. Dunno why anyone would be surprised that a biotech company is working on new drug candidates.
Sounds to me like things are reasonably on track. The MF population is limited, and the PV data are required for the target population of this drug increase significantly. Phase III RA is on track to begin later this year.
Aria:
This is just a standard disclosure. The FDA allows companies to start submitting applications in pieces so that they can begin the review process.
The important date is when aria notifies investors that the application is complete as submitted. At that point the FDA has 60 days to tell them if the application is indeed complete as per their inspection.
So really nothing special about this announcement. Aria has to tell investors that they've started the nda process. Any comment in the pr about the FDA being excited / enthusiastic about aria's application is not meaningful and is just bluster by the company.
I don't see the big deal about the pregnancy contraindication as Arena's drug is similarly contraindicated.
The only problem may be that Vivus is selling an ED drug along with Qnexa... makes their job a little tricky
Anyone know if the 'certified pharmacy' requirement is more or less cumbersome than the DEA scheduling / classification that Arena's drug received?
If the approval hasn't been reported on twitter yet, then I don't believe it
VVUS: Today is the PDUFA date. eom.
ONCY:
OT:
OT:
Gah!
How about a spoiler alert huh???
ARNA / VVUS:
I would think all this bodes well for VVUS as well.