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Re: robi-1-kenobi post# 77281

Wednesday, 12/04/2013 1:26:46 AM

Wednesday, December 04, 2013 1:26:46 AM

Post# of 146240
Worth reposting - NNVC Timeline Goals for 2014

Here are 2014 Goals for NNVC from Dr. Seymour's presentation at the LD Micro VI conference in LA, Dec. 3, 2013 (as transcribed by me - I couldn't copy it).

And good points, Puffer and Penguin! (Ha Ha - together sounds like a fun holiday show!)

If NNVC holds as well to this as they have with goals over the last year (which was also well presented on the same slide), 2014 should be a very good year.

2014 Goals

1. Initiate GLP FluCide toxicology studies (Q1)

2. Complete new pilot cGMP manufacturing plant (Q1)

3. Initiate FDA IND-required influenza studies at Lovelace and PHE including H7N9 (Q1)

4. Initiate final preclinical HIV study for candidate election (Q1)

5. Initiate new animal studies on ocular herpes (Q1)

6. Commission new pilot cGMP manufacturing plant (Q2)

7. Report results of H7N9 and MERS studies at both institutions (Lovelace and PHE) (Q2)

8. Sign Phase I/IIa human study contracts (Q2)

9. Report FluCide toxicology results (Q3)

10. File FluCide IND with both FDA and European Medicines Agency (EMA) (Q3-Q4)

11. Begin Human Trials of FluCide (Q4 or Q1 2015)*

*In Q&A Dr. Seymour also commented on Compassionate/Emergency Use Exemption that may allow earlier use of FluCide in people with life-threatening illness for where no other viable treatment is available. This would only be possible after animal studies (Tox #1/9 or PD #3 or both?) were completed.
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