NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its previously announced pre-IND Meeting was held with the USFDA on March 29th, 2012, as scheduled. This pre-IND meeting focused on FluCide™, designated as NV-INF-1, the Company's novel anti-influenza drug.
The Company received US FDA comments and exchanged a list of questions with the US FDA prior to the Meeting. The Company believes that the US FDA has given us a good roadmap for advancing towards an IND application.
The Company, with guidance from its regulatory consultants at the Biologics Consulting Group, Inc., had previously determined that filing a pre-IND at this stage was important in order to understand potential US FDA required studies that we will need to perform prior to filing an IND. Because of the novelty of the technology and approach, we requested this pre-IND meeting even before performing certain customary safety/toxicological studies.
The Company believes that it has received valuable guidance from the US FDA in this meeting. We believe that the guidance we received goes beyond FDA guidance documents, and is more specific for our drug candidate, NV-INF-1. The Company will now plan and execute the studies identified based on this meeting.
The Company also intends to pursue licensing activities in countries other than the USA. Some of these countries have different procedures that may enable faster regulatory processes than at the US FDA.
The Company also said that its work on enabling cGMP manufacturing capabilities for the nanoviricides drugs for clinical trials is progressing satisfactorily.
Newly identified antibodies target a hard-to-spot region of the influenza virus