Ask Dr. Danter: In your March 2nd press release you indicated that COTI-2 development was progressing and that the IND would be filed by the end of March. As the end of March is here, can you provide any update?
Thank you for this timely question. First, our COTI-2 program continues to progress. We have put in place a very experienced, high profile scientific advisory board to advise on the clinical development of COTI-2 and other assets. We continue to pursue opportunities for multiple clinical trial indications. We have also hired a very experienced clinical trial manager to oversee the clinical trials planned to begin later this year with the first trial at MDACC in women with gynecological cancers. Our IND application is a substantial high quality document of over 5,000 pages and is currently in the final step, called publishing, before the actual electronic IND application can be formally filed with the FDA. Publishing means that the various preclinical test reports and other materials such as scientific articles referenced in the IND application must be loaded into the FDA’s electronic data room and then hyperlinked from the IND application to these data room documents. This publishing process typically takes 2-3 weeks depending upon the size and complexity of the IND application with the average IND application containing from 3,000 to 5,000 pages. Generally speaking, the larger the submission the greater the number of references, which in turn impacts the extent of document hyperlinking and quality assurance required. With some recent publishing difficulties overcome we now anticipate the filing to be completed by mid-April.