Again this is just some peripheral stuff to keep the price from collapsing with the delay of the bell ringing. Get real folks....this process and the ultimate 911(g) approval will take years even in the best case scenario....while this is not PDUFA or a 510K it will be extremely lengthy ... There are 100 of pages of guidance in this area on the FDA website for modifed risk..
I thought we started a clinical trial run by the FDA last summer regarding our low nicotine leaf. It's not like we are starting from scratch and they have never heard of us before. Maybe the time line for once won't be quite as long as many of us expect. Here's hopin'.
Still looking for some good word on Botanical G. in the next 2-3 weeks.