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Re: petemantx post# 2274

Thursday, 12/05/2013 5:47:50 PM

Thursday, December 05, 2013 5:47:50 PM

Post# of 3756
I thought Joe's comments on VLN in Van's interview was the one of the most interesting parts of the interview. He said getting approval from FDA for VLN should be easy - and when you think about it it should be because VLN is just a statement of fact, not a health claim - so hopefully he is right. On the other hand, getting approval for a MODIFIED RISK claim, which is a health claim, requires evidence from trials, and I suspect that (might be wrong) they will have to wait the outcome of the S1P1 trial before getting approval.

http://clinicaltrials.gov/ct2/show/NCT01681875

But if they can get approval for VLN labeling soon, it should be huge and it's hard to imagine that other Big Tobacco would not want a VLN version of their major brands. Of course, getting approval for modified risk will be the holy grail.

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