Your email has been successfully added to our mailing list.

×
0 0 0 -0.0822784810126582 -0.0981012658227848 -0.0316455696202532 -0.113924050632911 -0.113924050632911
Stock impact report

Adamis Provides Regulatory Update on Sublingual Tadalafil

Adamis Pharmaceuticals Corporation (ADMP) 
Last adamis pharmaceuticals corporation earnings: 11/12 04:16 pm Check Earnings Report
Company Research Source: GlobeNewswire
SAN DIEGO, Feb. 26, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its sublingual tadalafil product. As previously announced, on December 28th, 2018, Adamis submitted an NDA for fast-disintegrating sublingual tadalafil (APC-8000) with the FDA for the treatment of erectile dysfunction (ED). Upon its preliminary review, the FDA determined that the submitted NDA was not sufficiently complete to permit a substantive review. The FDA requested that Adamis supplement and include in a resubmitted NDA (i) longer real-time (versus accelerated) stability data and (ii) additional dissolution data for both the clinical and registration batches. Adamis may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter with the agency and seek additional guidance concerni Show less Read more
Impact Snapshot
Event Time:
ADMP
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
Opt-in for ADMP alerts
Opt-in for
ADMP alerts

from News Quantified
Opt-in for
ADMP alerts

from News Quantified