Replies to post #78247 on NanoViricides Inc. (NNVC)

[robi-1-kenobi]

DD you're on the right track for probability of success. I don't know what the "market" thinks, but I think we can take a stab at probabilities of success based on assessment of each risk.

You say: at the lowest 30% probability of success toward getting approval for FluCide based on low Tox and no interaction within cells for its mechanism of action.

I am a bit less conservative (on this subject) and will go out on a limb.
IMHO I think >80% probability of FluCide marketing approval based on the following breakdown of risks.
[I can hear the howls from the doubters already!]

1. SAFETY - High confidence - no Tox to MFD in range-finding Tox animal study. Still need GLP Tox study. High probability of human success due to mechanism of action outside of cells and existing human data on constituents of the nanoviricide drug - unique to most drug development programs.

2. EFFICACY - High confidence - most animal and lab efficacy studies are successfully completed. Need more strains tested for broad spectrum indication. High probability of human success due to mechanism of action outside of cells - unique to most drug development programs.

3. MANAGEMENT/REGULATORY - Med/High confidence - most of risks would be delay (I don't think rejection) due to novelty of drug, but offset by very good chance of accelerated regulatory review by FDA. Also good chances for EMA, TGA, etc. Management has hired good contractors/consultants for the planning, execution of preclinical and clinical testing and writing of the submissions.

4. FINANCIAL - High confidence - sufficient funds through Phase I/IIb, good results allow further raising of funds with dilution balanced by increasing SP (market will place more value in particular for this step as BK indicates).

5. COMPETITIVE - Med/High confidence - strong patents protect this specific technology. Competitors identified to date haven't even had pre-IND meetings with FDA or started formal preclinical testing toward approval of clinical testing let alone marketing approval for commercial use. Competitors are always a threat though (as NP will attest to!).

Also, to answer your questions:
1. NNVC is really its own novel category at the moment. Small molecules are considered traditional "chemistry" drugs and large molecules new "bio" drugs. The size of the nanoviricides and the mechanism of action are more like large molecule "bio" drugs, but contain no "bio" components and so would likely be reviewed in FDA by CDER (drugs) than CBER (bio).
2. AFIK, Its lead indication will be for hospitalized in-patients for treatment of Flu, and its secondary indication will be for outpatient use.