Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Autism Observational Study Results and Next Steps
https://clients3.weblink.com.au/pdf/ZLD/02136667.pdf
This travesty will embolden the VLN push... it's coming... 8/10 want it...
Juul, Philip Morris Sued Under Racketeer Act for Targeting Kids
https://www.bloomberg.com/news/articles/2019-08-19/juul-philip-morris-sued-under-racketeer-act-for-targeting-kids
Nicotine is now a class A poison in Karnataka
https://www.thehindu.com/sci-tech/health/nicotine-is-now-a-class-a-poison-in-karnataka/article29167577.ece
Zelda Therapeutics Medical Marijuana and Autism Consensus Symposium 2019 in Philly/USA
https://www.eventbrite.com/e/zelda-therapeutics-medical-marijuana-and-autism-consensus-symposium-2019-registration-65253009508
Anyone attending?
It'll be okay, friends... *hugs*
“Our understanding of e-cigarettes is still accumulating, but at this point, we are pretty confident that e-cigarettes are at least two-thirds to three-fourths as bad as cigarettes,” says Stanton Glantz, Ph.D., professor of medicine at the University of California, San Francisco’s Center for Tobacco Control Research and Education. “And remember, cigarettes are pretty horrible. Vaping is like, instead of jumping out of the 40th story of a building, you’re jumping out of the 30th story.”
Other experts think Glantz is being conservative. Thanks to new chemical cocktails, the increased nicotine delivery, and the power of that drug on the brain (all the worse in concentrated form), Juuls and other e-cigarettes may in fact be worse than your average cancer stick.
https://www.yahoo.com/lifestyle/vaping-bad-finally-starting-learn-183326295.html
FDA Issues Proposed Rule to Require New Cigarette Health Warnings
https://www.fda.gov/news-events/press-announcements/fda-proposes-new-required-health-warnings-color-images-cigarette-packages-and-advertisements-promote?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=pressrelease&utm_campaign=CTP%20News%26Connect%26SOS%3A%20CHW%20-%2081419
The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.
The proposed rule will be open for public comments for 60 days through Oct. 15. Among other things, the FDA is seeking comments on the proposed cigarette health warnings and how many warnings should be selected for the final rule. Given the degree of public and stakeholder interest in this area, the FDA is also seeking proposals for alternative text and images, as well as scientific information to support a finding that the alternative text and images would advance the government interest in promoting greater public understanding of the negative health consequences of smoking.
In addition to the newly proposed cigarette health warnings, the FDA also continues to move forward on a number of separate measures to protect kids and significantly reduce tobacco-related disease and death as part of the agency’s comprehensive plan for tobacco and nicotine regulation.
If this will take ~15 months... we might be looking at 2 years for the change to VLN... FDA appears to hint at NPRM for nicotine coming in October...
Wow, just couple the upcoming NPRM with the previous article posted... I've never been more confident in this company's prospects
EXCELLENT news, shelby... and, to be fair to myself, is exactly what I said in the past... safety AND effectiveness will be priorities for companies putting out CBD oil, etc... and guess what? A scientific approach is the way to get there... the XXII approach...
I think this is exactly what Cliff was referring to when he said "more lucrative" in reference to hemp/cannabis...
Interesting.
I do believe the mandate is coming - more evidence from the 8/10 Americans study IMO, which was designed just for the purpose, I believe. And all the other reasons I stated in the past... it's a declining industry that has a lot less power than yrs past. Cliff's comment on hemp/cannabis is throwing me off a bit.
I still believe the other countries' argument relies heavily on those countries making a science-based decision... and they're waiting on our own FDA... it's free of cost.
COMMISSIONER GOTTLIEB: Yeah. So it would be a Notice of Proposed
Rulemaking, so if you get the Notice of Proposed Rulemaking out of FDA late this summer,
building in some time for that to slip. The last time we were committed to get the ANPRM
out in January, I think we got it out in March instead, so it slipped three months. And so you
have to allow some time buffer in these. You know, if you get that to the department and
OMB it’s hard to predict how long it would be under review, but that would just be an NPRM,
so it’d be out for probably a 90-day comment period and we would have to solicit comments
and then look to finalize the rule. So it’s a long rulemaking process.
You know, the average rule from proposed to final is two to three years if
you look historically just at the average FDA rule. And when you look at more complex rules
that are highly novel, it’s a little bit longer than that. The rulemaking process is long for a reason. We build very good administrative records.
We’ve been sued on the deeming rulemaking, the reg, and it’s been
sustained in court I think a number of times now because FDA develops very careful
administrative records around its rulemaking process
The largest concern now is timeline... once the rule is announced, how long til the change takes effect? I hope 1 yr max... my gut is telling me possibly longer... like 65/35... let's see... why did our new CEO say hemp/cannabis could be more lucrative... it's a statement that intrigues and bothers me...
From 8/2/19 MO earnings call transcript someone posted:
With regard to FDA issuing further guidance on their nicotine regulation, they had indicated that they may publish something later this year. Given the past track record, I think that means that it may or may not come out. But I think we've communicated before, we think that, ultimately, any implementation of a nicotine [ceiling] on cigarette products we think is a very long-term action, and it would take quite some time for FDA to finalize that regulation and implement it. And of course, we don't think that what they have proposed in the past is feasible today and we don't think it's supported by the science. So we may expect to see some short-term progress there, but we think it's a long-term impact.
Agreed
Just a matter of time... and truly, sooner than later... I can't imagine our ex-Philip Morris CEO the accepting-of-failure type
Yes, let’s wrap this up.
I'm on the same exact page.
Def an upgrade - no fluff. I was intrigued by the comment around hemp/cannabis possibly being more profitable than VLN... did I hear that right?
FDA Issues Warning Letters for 44 Illegally Marketed Tobacco Products
https://www.fda.gov/news-events/press-announcements/fda-notifies-four-companies-remove-44-flavored-e-liquid-and-hookah-tobacco-products-market-not?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=pressrelease&utm_campaign=CTP%20News%3A%20Unauthorized%20TP%20WLs%20-%208819
Not playing around...
andre, you wrote this stock off already. You lacked the vision. Yes, solid hire. Good day.
Yes - I think legacy can be part of it... could also be a plant for collaboration w/ PM... IQOS was not rigorously tested to receive FDA approval in USA... I think PM is on board w/ VLN... more like acquiescing...
Agree with everything except one thing... shorts may be in control until we're making money/deals announced. I'm not completely convinced approvals matter, for them... but I could be wrong.
Former PM CEO is extremely validating IMO...
Straighten your backbone. We're not settling for pennies.
Oh you fooled me... no the reaction doesn't matter until results happen... the shorts are in full control...
Waiting game, with increased confidence...
Positive talk from Gio! Now I'm willing to stake my life on this company's future :)
PM hasn't been outspoken against VLN as BTI has... IMO- PM collaboration coming...
..."smoke-free future"... it's inevitable, as I said... yearly cig declines... etc. it's all culminating...
Even the new CEO is using my words: "the Company’s efforts in tobacco-harm reduction are coming to fruition" LOL
Cliff Fleet, former PM CEO, is our new CEO
https://www.businesswire.com/news/home/20190805005246/en/
Some light smokers out there? Try 8 out of every 10 Americans, incl. smokers.
I think BT has 1 yr to make the change... from October. Remember all the orgs./American Societies etc. that signed a letter written to the FDA, urging for VLN mandate? They want this by March 2020.
I say 1 yr.
Because they'll just need to license it when the time comes...
In other news:
Good read- http://www.startribune.com/state-has-297m-invested-in-tobacco-companies/516692431/?refresh=true
300 mil? Wow- https://www.newcannabisventures.com/cronos-group-to-buy-american-hemp-cbd-assets-for-300-million/
The battle rages on... we will win the war: https://www.washingtonexaminer.com/opinion/pricing-pleasure-at-fda
The FDA's proposal to slash the amount of nicotine in cigarettes mentioned consumer surplus almost as an afterthought. Then, for its possible bans on flavored tobacco products, consumer surplus was left out of the analysis altogether.
By ignoring or downplaying some of the highest costs of these policies, the FDA is stacking the deck in a way that makes almost any rule regulating or banning tobacco shake out as a net benefit.
It's bad policy and bad economics. Fair cost-benefit analyses of the FDA's tobacco regulations must provide an estimate of the loss of pleasure experienced by smokers or vapers. The FDA should be able to explain regulatory trade-offs, how its proposed rules would lead to optimal outcomes, and why the potential benefits of a rule should outweigh what consumers would lose.
Link to an active ZLDAF forum board... https://hotcopper.com.au/asx/zld/
https://hotcopper.com.au/asx/zld/
They're late with everything - but still, it's happening...
October, friend
FDA Seeks Public Input on Additional Tobacco HPHCs and Determining Criteria
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-seeks-comment-proposed-additions-list-harmful-and-potentially-harmful-constituents?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=FDAinbrief&utm_campaign=CTP%20News%3A%20HPHC%20Addition%20FRN%20-%208219
It's August (and Swiss National Day)... 2 months and we're in NPRM zone...
When the NPRM happens in the USA, other countries will follow our science... an argument won't have to be made... surveying the public of respective countries may be the only studies that would need to occur, IMO, for governments to easily implement VLN elsewhere because again- the science will have been painstakingly established and then it is left to the public... 8/10 Americans in the US is a grand slam, do not forget
The main question will be how long BT is given to make the switch-over... not more than 1 year... is our hope. Prior to that date, however, licensing or BO will naturally occur...
The chips begin to truly fall in October...
Vaping giant Juul faces another probe of its marketing
https://www.foxbusiness.com/features/juul-vaping-e-cigarette-marketing-investigation
I'm not worried about the now.
Wish I had more $ to invest...
The CBD craze is getting out of hand. The FDA needs to act.
https://www.washingtonpost.com/opinions/the-cbd-craze-is-getting-out-of-hand-the-fda-needs-to-act/2019/07/30/94c8024c-b211-11e9-8f6c-7828e68cb15f_story.html?noredirect=on&utm_term=.64ed46d65036
Trump Administration Plans To Allow Imports Of Some Prescription Drugs From Canada
https://www.npr.org/2019/07/31/746905508/trump-administration-plans-to-let-prescription-drugs-be-imported-to-u-s
You already know we need a very small percentage of the current market share to skyrocket...
Altria posts mixed quarterly results, says cigarette sales decline is acclerating
https://www.cnbc.com/2019/07/30/altria-q2-earnings-2019.html
Wait til the rule goes into effect, you s0b!