NNVC tripled in 2013, 2014 double very possible (per Noretreat's comment).
The SP has had mixed responses to previous milestone and announcements that I thought might be even better catalysts, but in the end the stock still tripled this year.
IMHO What could not be ignored in 2014 is the filing of the IND for FluCide. I think that would translate to another substantial SP increase in 2014.
An IND filing with FDA and EMA for clinical trials would mean:
1. Manufacture of sufficient quantities consistent materials for GLP Tox start
2. Study and Report on GLP Tox (expected confirmation of extensive non-GLP range finding Tox study)
3. Studies and Reports on in vitro and in vivo studies of efficacy of FluCide for multi-spectrum indication (Lovelace Respiratory Research Inst (LRRI) and/or Public Health England (PHE))
4. Completion/Qualification of cGMP manufacturing facility
5. Manufacture of first cGMP batches for stability studies (probably 3mo to get 6mo shelf life for clinical study - more than needed)
These are all within the control of the company this year - preclinical testing, technical work, writing of submission.
FDA and EMA will then review. If the filing is early enough, approval to begin clinical trials could come as early as Q4 2014 or Q1 2015.
The timing of the review is not, of course, in the company's control. FDA is FDA and will take all the time they need/want to review, ask questions and ultimately approve. EMA is probably a better bet for faster approval. While FluCide addresses an important unmet clinical need, FDA priority reviews generally don't come until NDA filing in my understanding.
I am looking to the IND filing as key to SP increase, but the other milestones listed by BK (and more below) could also provide catalysts for SP.
I. Public Health England studies of FluCide for high fatality MERS CoV and H7N9 Bird Flu
II. Lovelace Respiratory Research Institute studies of FluCide for MERS CoV and H7N9
Note on I and II: The MERS CoV and H7N9 studies above look planned-in by NNVC for IND-enabling efficacy studies according to press releases. I have listed them separately here as only 1 is needed for IND - or none if they forgo that indication in the interest of accelerated IND timing.
III. Oral FluCide development
IV. DengueCide development
V. EKC-Cide/Ocular HerpesCide development
VI. Final preclinical HIV study to select final nanoviricide candidate for clinical studies
Lots of important work the company has communicated as on tap for this year. I am looking to expand on the triple of my initial investment with additional shares going into 2014 - which looks very promising IMHO. Good luck to all!
AI
