22nd Century Group Inc (XXII)

[esad1]

You have to remember, this is the first FDA attack on nicotine and they are taking on six enormous corporations worldwide. Viagra was originally a heart drug in trails until the clinicians notice a definite side effect. Nicotine has never been in clinical trials and big tobacco keeps saying it is not harmful. You notice the billions being spent on e-cigs and heat not burn. Big tobacco knows they are on a short string. But I think the FDA does not want a mistake made in here where the politicians get involved. That is why I think after the Congress leaves this week there is nothing until the November mid-terms and then it is lame duck city. I don't think the FDA wants any political strife. Notice how they are dragging their feet in iQOS? (This morning the BBC reported vaping is causing serious trouble to lung tissue.)

There are not many people that want to keep cigarettes selling with nicotine and addiction. You and others seem not to understand the ANPRMs. That is as direct as you can get by going into the Federal Register and getting the public involved. That process just ended on July 16th. Give them a break. Of course I am angry they have dragged their feet on out application but they need it clean and irrefutable. They asked for the three trials we are doing now to answer all the questions that could arise. Gottlieb et al have to cut big tobacco off at the knees so they have no case to sue or complain.

Into the 17th month with no disclosure of the Phase III clinical data. You know it is being held out of the public eye as it will be clinical proof to go along with our scientific proof.

We are all in this hurry to get acceptance of our VLN that we all know works. There are people here who keep blaming Henry and management for doing nothing. Do you really think they like this FDA glacial pace? They need validation and it is out there. We get our application filed and fast tracked and we will see tremendous interest in our company. I am looking forward to all the filings by institutions that have to be made by 8/15. Be interesting to see what they show. Institutions own 20% of the float now and cost to borrow is still 36%.