NanoViricides Inc. (NNVC)

[KMBJN]

All the other companies like NNVC developing flu treatments also follow the FDA guidelines and requirements to do pre-clinical efficacy studies. Are we really to believe that FDA, NNVC, BioCryst, AVI BioPharma, Ansun, and other drug companies are all confused or lying, with companies doing preclinical efficacy studies against multiple flu strains - studies that don't need to be done?

http://www.businesswire.com/news/home/20060509005508/en/AVI-BioPharma-Reports-Preclinical-Data-Multiple-Strains

"Efficacy data observed in cell culture with the H1N1 strain, previously reported by Drs. Jianzhu and Chen Qin Ge at Massachusetts Institute of Technology, has been confirmed by Dr. P. Puthavathana at Mahidol University in Bangkok, Thailand, against an H5N1 viral isolate; by Dr. Darwyn Kobasa at the Public Health Agency of Canada in Winnipeg, Manitoba, against both the H1N1 and H3N2 strains; and by Dr. Manoj Pastey at Oregon State University in Corvallis, Ore., against the H7N7 and H3N8 strains."

"Additional dose escalation studies with NEUGENE antisense agents are underway, and studies to evaluate protection of mice and ferrets against both H1N1 and H5N1 strains are planned to support an Investigational New Drug (IND) application."

http://investor.shareholder.com/biocryst/releasedetail.cfm?releaseid=180511

"BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for injectable formulations of peramivir, the company's influenza neuraminidase inhibitor. In preclinical studies, peramivir has shown potent, broad-spectrum activity against multiple strains of flu, including the H5N1 virus."

Even NexBio/Ansun did preclinical efficacy studies on DAS181/FluDase:

https://www.ncbi.nlm.nih.gov/pubmed/16569867

"DAS181 demonstrated potent antiviral and cell protective efficacies against a panel of laboratory strains and clinical isolates of IFV A and IFV B, with virus replication inhibition 50% effective concentrations in the range of 0.04 to 0.9 nM. Mouse and ferret studies confirmed significant in vivo efficacy of the sialidase fusion in both prophylactic and treatment modes."

Why are all these stupid companies doing preclinical efficacy studies as FDA guided?

It's interesting that peramavir was granted emergency use exemption by the FDA during the 2009 H1N1 flu pandemic before FDA had given full approval and Phase III trials had completed:

http://www.nejm.org/doi/full/10.1056/NEJMp0910479#t=article