NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Your "Fake Tox" post is plain wrong and twisted, confusing the issue.

See below. Later requirements for clinical trials DO NOT default to the same requirements for earlier Tox studies.
Just because stricter requirements apply to later studies does not mean those same requirements apply to the earlier studies.

Summary of Material Requirements for studies (from memory, but I think accurate):

1. Regulatory Toxicity Studies
- documented, well characterized test material that allows for comparison to clinical materials
- the minimum requirement for a GLP study - but not ever described by industry to my knowledge as "cGLP standard" - there is no "GLP standard" to meet in the guidances or standards).
- cGMP or cGMP-like with full CMC controls and descriptions of the manufacturing process and material properties is recommended, but NOT required.

2. Phase I Clinical Trials for both TGA (Australia) and FDA (US)
- cGMP-like materials are required for the study.
- Documentation showing the consistency and comparability of Tox materials used for preclinical testing to the Clinical materials planned for use in the clinical trial is required.
- cGMP materials are recommended.
- For Australia, either TGA or IRBs review and decide acceptability of all data (including comparability of materials, but also much more) prior to human use.
- For US, FDA makes the call.

3. Phase II, etc Clinical Trials for both TGA and FDA
- cGMP materials are required.