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motorcity

12/20/19 8:16 AM

#63168 RE: Deetew #63162

Re: FDA regs

It's obvious they are dragging their feet on this.

The FDA is approving drugs in record time. 5 drugs were approved in 10 weeks this year.

Their silence is deafening.

I see no reason that after the May hearings they couldn't have had something done within three months.

In my opinion this isn't a lack of knowledge it's a lack of desire for whatever reason.

And I have to say I'm very disappointed in Mitch McConnell with the spending bill. He talked a big game about forcing the fda's hand and then in the end it turns out the verbage in the bill actually came from Chuck Schumer. Go figure.

MartyTamreau

12/20/19 9:33 AM

#63169 RE: Deetew #63162

Deetew: states have always been better at quicker, more pragmatic decisions. Sometimes they get it wrong, and sometimes not. FDA is so twitchy because their decisions apply federally. We're already seeing big states signal that they'll make a decision and not wait for the federal government. Just how MJ, legal and recreational went. One could argue that there is already a groundswell of support for CBD, but still in gray land. I agree with very little our President believes in but he is at his core a businessman and I think his most wasted oppportunity and a way to increase his chances of re-election is to facilitate the growth of the MJ/CBD business. I know he is a teetotaler, but lots of his constituents are not. At it's core, a big missed business opportunity for the supposed deal maker.

The states will be ahead of this an eventually, FDA will need to respond. I really believe that the position we are in is the strongest (e.g., GRAS, toxicology, controlled clinical trial, 5 years of brand selling experience, a regulatory expert (Duffy) in place). People will argue that GRAS is a nothing burger, and so far that is correct. It hasn't been perceived as a big advantage because the world is not knowledgeable and FDA has muddied the waters big time. But it will be an advantage and when it moves it will move big. It will be the main driver for getting into mainstream companies who have so far been afraid.

2020 with be an excellent year; I missed cashing out on Wave 1 (2019); but we'll all have the chance in Wave 2 and beyond.

Happy holidays to all of you.

MT