InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
Subscribe Login/Register
S&P 500
5,431.60
(
-0.04%
)
US TECH 100
19,168.00
(
0.52%
)
Dow Jones
38,589.16
(
-0.15%
)
Brent Oil
82.28
(
0.00%
)
Bitcoin
66,235.57
(
0.35%
)
Post# of 252199
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Keep Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

steveporsche

Send PM Follow Ignore
Followers 2
Posts 283
Boards Moderated 0
Alias Born 08/25/2006

steveporsche

Re: mcbio post# 111246

Wednesday, 12/22/2010 12:03:34 AM

Wednesday, December 22, 2010 12:03:34 AM

Post# of 252199
EXEL - Some reading for you:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm182443.htm

There are other documents more specific to HRPC in general, but it would take me a while to find. There was a FDA Prostate Cancer Workshop pre-Impact results (and follow-up publication shortly post Impact results) discussing the suitability of various endpoints in HRPC. It has been a long while since I looked at this stuff. They better have a SPA for the P3 as Pazdur wants survival as the primary.
Public Reply Private Reply New Post
Keep Last Read
Keep Last Read Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up