Item 8.01 Other Events.
On
In the ORA-D-013-1 trial, patients were randomized 2:2:1:1 into four groups: 8 mg dosed once-daily; 8 mg dosed twice-daily; placebo dosed once-daily; and placebo dosed twice-daily. Patients completed an initial 21-day screening period, followed by a 26-week double-blind treatment period.
Warning Concerning Forward-Looking Statements
This Current Report on Form 8-K contains statements which constitute
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and other securities laws. These forward-looking
statements are based upon the Company's present intent, beliefs or expectations,
but forward-looking statements are not guaranteed to occur and may not occur for
various reasons, including some reasons which are beyond the Company's control.
For example, this Report discusses our discontinuation of clinical trial
activities for ORMD-0801 and the potential safety and efficacy of ORMD-0801.
These forward-looking statements are based on the current expectations of the
management of the Company only, and are subject to a number of factors and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements, including the risk that the Company
may not be able to successfully implement its strategic plans; the risks and
uncertainties related to the progress, timing, cost and results of current and
future clinical trials and product development programs; difficulties or delays
in obtaining regulatory approval or patent protection for the Company's product
candidates; competition from other pharmaceutical or biotechnology companies;
and the Company's ability to obtain additional funding required to conduct its
research, development and commercialization activities. In addition, the
following factors, among others, could cause actual results to differ materially
from those described in the forward-looking statements: changes in technology
and market requirements; delays or obstacles in launching the Company's clinical
trials; changes in legislation; inability to timely develop and introduce new
technologies, products and applications; lack of validation of the Company's
technology as it progresses further and lack of acceptance of its methods by the
scientific community; inability to retain or attract key employees whose
knowledge is essential to the development of the Company's products; unforeseen
scientific difficulties that may develop with its process; greater cost of final
product than anticipated; loss of market share and pressure on pricing resulting
from competition; laboratory results that do not translate to equally good
results in real settings; the Company's patents may not be sufficient; that
products may harm recipients; and other factors discussed in the "Risk Factors"
section of the Company's most recent Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q, each of which is on file with the
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