Specifically , the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA , the possibility that the NDA submission will not be completed in the second quarter of 2009 , that priority review is not granted and that a decision by the FDA is not rendered in late 2009 , the Company will be able to complete strategic partnerships , the Company 's ability to continue to raise capital as needed to fund its operations , competitive factors , technological developments , costs of developing , producing and selling pixantrone , and the risk factors listed or described from time to time in the Company 's filings with the Securities and Exchange Commission including , without limitation , the Company 's most recent filings on Forms 10-K , 8-K , and 10-Q .