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leifsmith

08/09/12 12:02 PM

#61814 RE: leifsmith #61813

This company does not need to be "rescued" or "saved" by big pharma or anyone else. All they have to do is: 1) tox; 2) clinical trials; 3) sell the cure for flu to people who have flu.

Steps 1, 2 (in Australia) do not require completion of a cGMP manufacturing facility. The requirement is much simpler: a GLP (Good Practices Laboratory). By the time for step 3 the cGMP plant will be done.

This all seems very clear and direct. Would like to know where the problems are.
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jg35

08/09/12 12:11 PM

#61815 RE: leifsmith #61813

For the same reason most start ups fail by running out of money. They have no source of income but must keep spending more money to move things along.

What if issues arise in the toxicity studies, requiring further tests and thus delaying the trials once again? What if issues arise in the phase I trials? What if the stuff is nontoxic, but just doesn't work in humans? (We are not rats.) Again, the chart for success of NNVC requires that everything work. And that a company best known for missing important milestones actually gets things done on time.