This is taken from an End of Phase 2 Meeting Presentation by FDA. Just to set people straight since some try to instill fear and doubt. Obviously Prana is well into this process.
EOP 2 Meeting
• Objectives:
– To obtain agreement on pivotal study designs, and safety and efficacy endpoints for Phase 3 studies
– To update on progress of PK studies and discuss additional studies needed
– To assure that pre-clinical data with regard to duration, route of administration, and formulation are supportive of the dose to be used in clinical trials
CMC
– To discuss approach to specifications and test methods
– To discuss “to be marketed” formulation
– To evaluate appropriate protocols
– To identify other issues or potential problems (novel regulatory or technical concerns)
EOP2 meeting briefing package
• Summaries of Phase 1 and Phase 2 investigations
• Summary information on plans for Phase 3 trials
• Specific protocols for Phase 3 studies
• Plans for pediatric studies
• Plans for additional non clinical studies (if required)
- Forums
- ASX - By Stock
- Content of End of Phase 2 Meetings with FDA
This is taken from an End of Phase 2 Meeting Presentation by...
-
- There are more pages in this discussion • 6 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add ATH (ASX) to my watchlist
(20min delay)
|
|||||
Last
0.5¢ |
Change
0.001(25.0%) |
Mkt cap ! $26.19M |
Open | High | Low | Value | Volume |
0.5¢ | 0.5¢ | 0.5¢ | $27.94K | 6.050M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
47 | 58163299 | 0.4¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
0.5¢ | 57489001 | 48 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
47 | 58163299 | 0.004 |
75 | 84508146 | 0.003 |
19 | 29345125 | 0.002 |
16 | 81865102 | 0.001 |
0 | 0 | 0.000 |
Price($) | Vol. | No. |
---|---|---|
0.005 | 57455001 | 47 |
0.006 | 17905330 | 28 |
0.007 | 9788861 | 19 |
0.008 | 8393109 | 16 |
0.009 | 4646078 | 9 |
Last trade - 16.10pm 28/03/2024 (20 minute delay) ? |
|
|||||
Last
0.5¢ |
  |
Change
0.001 ( 0.00 %) |
|||
Open | High | Low | Volume | ||
0.5¢ | 0.5¢ | 0.5¢ | 20524121 | ||
Last updated 15.46pm 28/03/2024 ? |
Featured News
ATH (ASX) Chart |
The Watchlist
BGD
BARTON GOLD HOLDINGS LIMITED
Alex Scanlon, Managing Director & CEO
Alex Scanlon
Managing Director & CEO
SPONSORED BY The Market Online