Absolutely - and unless you have a very imaginative solution up your sleeve that no one else has been able to think of - GRAS is the only practical and expeditious way forward.
...to make publication of safety data a condition is a cop out and achieves what.
A cop out by who? This was the condition place on the finding, live with it. What does it achieve? Exactly what you want - access to the mass market.
The GRAS process probably started 18mths ago and still isn`t complete, that is a real cost in terms of value lost in sales and patent life.
Short of a resort to magical thinking, these is part of our real-world life. Things take time. But, your suggestion that somehow the company short circuit the legal niceties may be a quick route to corporate collapse and crushing legal expense defending against criminal charges. Speaking for myself, I am grateful that cooler heads are in charge.
CZD Price at posting:
4.6¢ Sentiment: Buy Disclosure: Held