Saturday, August 27, 2016 8:15:14 PM
Until NNVC has a pre-IND meeting with the FDA for this particular indication, nobody knows what the FDA will require. NOBODY.
If some component of NNVC's formulated version diffuses through the skin and enters the bloodstream, *every* tox test will be required.
Why hasn't NNVC had that pre-IND meeting with the FDA? Something very simple, yet NNVC has not yet had that meeting. Why?
In addition to the tox studies, the chemistry studies are also required for the IND application.
Included in the chemistry studies are stability studies. They require some months.
Not only does NNVC have to figure out how to make enough quantity, they have to formulate it for dermal application. That formulation has to remain stable. Stable over months.
How could NNVC have even started to work on these issues if they haven't yet identified their lead candidate?
These matters are not resolved in weeks or months.
A casual stroll through the lunatic asylum shows that faith does not prove anything. Friedrich Nietzsche
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