InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
Subscribe Login/Register
S&P 500
5,473.23
(
0.00%
)
US TECH 100
19,408.40
(
0.03%
)
Dow Jones
38,778.10
(
0.00%
)
Brent Oil
83.75
(
-0.18%
)
Bitcoin
65,224.96
(
-1.90%
)
Post# of 252235
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

genisi

Send PM Follow Ignore
Followers 29
Posts 5148
Boards Moderated 0
Alias Born 05/24/2006

genisi

Re: oc631 post# 153004

Tuesday, 11/27/2012 6:38:39 AM

Tuesday, November 27, 2012 6:38:39 AM

Post# of 252235
PBTH

Do you think the rumored pivotal study design would be sufficiently powered for the FDA to accept a BLA filing without a SPA?

Yes, I think so. Also heard Mr. Novik a while ago. Seems the comp believes so. Said they got orphan designation and therefore needs only one pivotal phase III for approval. They are going to start the phase III trial of hGH-CTP in adult early next year. Design is: 150 patients, 2 arms (vs placebo), 6 months treatment with 6-12 extension for safety, primary endpoint will be change in truncal fat, cost ~ $15M, NDA filing in 2015.
Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (1) 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