NNVC's remarkable and solid progress in last 6 months
It began with the submission of an Orphan drug designation to the FDA for Dengue on 10 June when the SP was at a (split adjusted) SP of about 2.10
That began a very strong uptrend with a steady stream of very solid and significant developments:
7/11 letter of intent to file for Dengue orphan drug designation with European Medicines Agency
7/18 agreement with Public Health England for for the testing of different nanoviricides, such as FluCide(R), against viruses of "mutual interest" to both organizations and specifically H7N9 and MERS
7/22 NNVC notified that the Committee on Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA) has appointed a team of clinical coordinators for the purpose of reviewing the Company's upcoming orphan drug designation application for DengueCide(TM
8/5 non-disclosure agreement (NDA) with the Lovelace Respiratory Research Institute ("LRRI"). The Company intends to enter into a Master Services Agreement with LRRI for the IND-enabling efficacy studies of both its broad-spectrum injectable and oral FluCide(R) drug candidates. These studies will employ multiple unrelated subtypes and strains of Influenza A, including the novel H7N9 strain, the subtype which is currently circulating in China . The Company has already shown that the injectable and oral FluCide drug candidates are substantially more effective than oseltamivir (Tamiflu(R)) in controlling influenza A virus infections in a highly lethal animal model using two unrelated subtypes of influenza A, namely H1N1 and H3N2. In addition to FluCide, LRRI will also be able to evaluate the Company's anti-MERS drug candidates in cell culture and animal models when available.
8/12 Orphan drug designation for Denguecide receceived from FDA
8/19 reported today that the renovation of the facility in Shelton, CT , to build its new clinical scale cGMP production plant is progressing on schedule.
The Company reports that its project for enabling clinical scale drug product cGMP capability is now in the Construction phase. Design, engineering, and architecture for this facility were completed at the end of June, 2013. Subcontractors were retained at the end of June as well. The demolition plan was executed in July, 2013. Initial construction work began on schedule in August and is now being performed at full force. The construction is on schedule to be completed by the end of December, 2013. >>>>However, the schedule may be adversely affected if delivery of certain key pieces of equipment with relatively long lead times does not occur in a timely manner<<< [[we were warned in advance of that potential problem!]]
9/3 NNVC reports application to EMA for orphan drug for DengueCide submitted
9/10 NNVC announces reverse (3.5:1) split, now meets standards for listing on a higher exchange, has sold out a secondary at 3.50 raising $9.3 million 9/12 adjusts figure to $10.33 million
9/13 Both CXCR4 and CCR5 using strains of HIV (the major strains of concern) strong inhibited by NNVC anti-hiv drug.
9/25 NNVC begins listing on NYSE-MKT
10/1 annual report - has sufficient funds to advance a drug candidate into clinical trials
10/7 initiation of toxicology studies for Flucide.
10/21 Flucide found to be well tolerated in a non-GLP small animal safety/toxicology study. The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway. This non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts.
