pSivida Announces FDA Acceptance For Filing of New Drug Application (NDA) for Durasert™ Three-Year Treatment for Posterior Segment Uveitis
PSIVIDA (PSDV)
Last psivida earnings: 2/7 04:02 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investors.psivida.com
Company Research
Source: GlobeNewswire
WATERTOWN, Mass., March 19, 2018 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today announced that its New Drug Application (NDA) for Durasert three-year treatment for posterior segment uveitis has been accepted by the U.S. Food and Drug Administration (FDA) for filing. The acceptance of the NDA reflects the FDA’s determination that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018. The PDUFA date is the goal date for the FDA to complete its review of the NDA. The NDA includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months with a p value "The FDA’s acceptance for review of our Durasert NDA submission is a major milestone for pSivida and we look forward to continuing to work w
Show less
Read more
Impact Snapshot
Event Time:
PSDV
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
PSDV alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
PSDV alerts
High impacting PSIVIDA news events
Weekly update
A roundup of the hottest topics