Alfacell has completed patient enrollment in a confirmatory Phase IIIbclinical trial for ONCONASE in patients suffering from unresectable malignantmesothelioma (UMM) and reached the required number of evaluable events toconduct the formal statistical analyses required to complete the finalsections of the ONCONASE rolling NDA. Based on the preliminary statistical analysisof the data, Alfacell will continue with the planned submission of theremaining components of the ONCONASE rolling NDA. The company has completed enrollment in its Phase I clinical trials forpatients suffering from non-small cell lung cancer (NSCLC) and other solidtumors and is now currently planning for the follow-on Phase II clinicaltrials. Factors that wouldcause or contribute to such differences include, but are not limited to,uncertainty whether the clinical trial results will allow the company tocomplete submission of a New Drug Application and if a New Drug Applicationsubmission is completed, uncertainty whether FDA will file or approve suchapplication, uncertainties involved in transitioning from concept to product,uncertainties involving the ability of the company to finance research anddevelopment activities, potential challenges to or violations of patents,uncertainties regarding the outcome of clinical trials or differences ofopinion in interpreting the results of clinical trials, the company’s abilityto secure necessary approvals from regulatory agencies, dependence uponthird-party vendors, and other risks discussed in the company’s periodicfilings with the Securities and Exchange Commission. read more