definiens: within the meaning of the PrivateSecurities Litigation Reform Act of 1995 . Such forward - looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materiallydifferent from any future results, performance, or achievements expressed or implied by such forward - lookingstatements . Forward - looking statements may include, but are not limited to : · our ability to fund or obtain funding for our continuing operations;·the expected results of clinical studies relating to LTX-04 or any successor product candidate, the date bywhich such study results will be available and whether LTX-04 or any successor product candidate willultimately receive FDA approval;·whether LIMITX will retard the release of opioid active ingredients as dose levels increase;·whether we will be able to reformulate LTX-04 or any successor product candidate to provide an efficaciouslevel of drug when one or two tablets are taken;·whether we will be able to reformulate LTX-04 or any successor product candidate to improve its abusedeterrent performance;·whether the extent to which products formulated with the LIMITX technology deter abuse will be determinedsufficient by the FDA to support approval or labelling describing abuse deterrent features;·whether our LIMITX technology can be expanded into extended - release formulations;·our and our licensee ’s ability to successfully launch and commercialize our products and technologies, including Oxaydo ® Tablets and our Nexafed ® products;·our and our licensee ’s ability to obtain necessary regulatory approvals and commercialize products utilizing ourtechnologies;·the market acceptance of, timing of commercial launch and competitive environment for any of our products;·expectations regarding potential market share for our products;·our ability to develop and enter into additional license agreements for our product candidates using ourtechnologies;·the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;·the ability of our patents to protect our products from generic competition and our ability to protect and enforceour patent rights in any paragraph IV patent infringement litigation;·the ability to fulfill the FDA requirements for approving our product candidates for commercial manufacturingand distribution in the United States, including, without limitation, the adequacy of the results of the laboratoryand clinical studies completed to date, the results of laboratory and clinical studies we may complete in thefuture to support FDA approval of our product candidates and the sufficiency of our development process tomeet over - the - counter ( ) Monograph standards, as applicable;·the adequacy of the development program for our product candidates, including whether additional clinicalstudies will be required to support FDA approval of our product candidates;·changes in regulatory requirements ; 46 · adverse safety findings relating to our commercialized products or product candidates in development;·whether the FDA will agree with our analysis of our clinical and laboratory studies;·whether further studies of our product candidates will be required to support FDA approval;·whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposedindications and whether we will be able to promote the features of our abuse discouraging technologies ; and·whether Oxaydo or our Aversion and LIMITX product candidates will ultimately deter abuse in commercialsettings and whether our Nexafed products and Impede technology product candidates will disrupt theprocessing of pseudoephedrine into methamphetamine