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Is brilacidin the best drug that will never see the light of day? How do we change that?
Gee I wonder what "Monsanto of Cannabis" could help with this problem....
Canopy says its share of the critical Canadian recreational dried flower market fell in both the premium and value-priced categories in its latest quarter due to a lack of cannabis with "in-demand attributes" like higher potency.
I've been in this stock a long time, and wouldn't invest if I didn't see the great potential in the science. Is it bad that I now always expect Leo to overpromise and under-deliver?
Can't argue with that, he should be more transparent. With such a massive potential dilution to loyal shareholders (of 200,000,000 shares) it seems only reasonable that Leo would come clean on the performance metrics. Otherwise we can assume the targets are embarrassingly conservative for such massive dilution? Is he concerned about a shareholder lawsuit?
Three and a half years since notice of proposed rulemaking. Wow that’s a real confidence builder. Where the leadership? Mitch z? BT owns the FDA.
If he doesn't yet he should.....application site for Leo. Maybe it could be the first of several grants....
Fast Grants for COVID-19
If you are a scientist at an academic institution currently working on a COVID-19 related project and in need of funding, we invite you to apply for a Fast Grant. Fast Grants are $10k to $500k and decisions are made in under 14 days.
If you wish to apply to grants for scientific or biomedical COVID-19 projects, please apply through FastGrants.org.
Sounds like Leo should be talking to these guys...
TOGETHER is funded by private philanthropists, including Fast Grants, an initiative by Silicon Valley billionaire Patrick Collison and economist Tyler Cowen to speed pandemic response by getting grant money out rapidly.
Thanks, looks like the strongest argument I've seen for the implementation of a nicotine mandate!!
"In the real world, there is little evidence that smokers will use this product or any other very low nicotine product exclusively, and there is abundant evidence to the contrary.
To be effective for harm reduction, full-nicotine cigarettes must not be available to smokers."
Good to see Big Tobacco is finally coming around!!
sounds like government speak for cheque is in the mail
wow 196 patient phase 2b/3 trial and they'll likely get EUA from the FDA.
Hey Barda how about throwing a few dollars at the swiss army knife of pandemic protection?
https://endpts.com/barda-looks-to-get-the-jump-on-next-pandemic-with-vc-arm-targeting-transformative-tech/
They don’t offer VLN
Light Blue Pack. 'Regular Full-Bodied Taste' Tar (K)16.0 mg. Nicotine (N)1.79 mg.
Green White Pack. 'Menthol Light Mellow Taste' Tar (K)13.1 mg. Nicotine (N)1.42 mg.
Maroon Pack. Organic 'Regular Full-Bodied Taste' Tar (K)13.3 mg. Nicotine (N)1.58 mg.
Black Pack. 'Perique Tobacco Blend - Rich Robust Taste' Tar (K)16.5mg.
Why would anyone partner with IPIX? Gee maybe 99% reduction in COVID!!
The data revealed that brilacidin and favipiravir independently exerted up to 90% and 80% inhibition, respectively, and the extent of inhibition did not increase over that exerted by brilacidin alone when the two drugs were used in combination (Figure 5A). In contrast, combination of brilacidin with remdesivir at 10 and 2.5 µM concentrations, respectively,
reduced the viral infectious titer by >99%, thus providing a highly effective inhibition profile (Figure 5B) and achieving greater inhibition than with either compound alone.
https://www.mdpi.com/1999-4915/13/2/271/htm
Well Vir is a $6 billion company that just got EUA on a 40 patient phase 2 trial. Sure they're far ahead of us with partnerships and grants, but if Brilacidin is successful in its phase 2 trial it sure looks like a multi billion dollar valuation is quite achievable.
How do they get EUA on a phase 2 study with 40 participants (that shows as still recruiting)?
https://clinicaltrials.gov/ct2/show/NCT04779879?term=VIR-7831&draw=2&rank=1
The research was very clear!
"The high CC50 (a measure of cytotoxicity) and low IC50 (a measure of potency) values observed for brilacidin in Calu-3 cells—yielding a Selectivity Index (SI) for brilacidin of 426 (CC50 = 241 µM/IC50 = 0.565 µM)—strongly support brilacidin’s treatment potential to achieve positive antiviral outcomes in humans. A vast majority of other drugs being evaluated as potential COVID-19 treatments, including repurposed drugs, have SIs that are much lower than that achieved by brilacidin"
I don’t get it. How can they mandate seat belts, air bags and ABS but not VLN? Cigarettes are the leading cause of preventable death.
Is anyone else concerned that B (under the old Polymedix study) had more AEs when it was given at higher doses (and longer time?) with ABBSSSI? When IPIX re-ran study I recall they reduced the dose (and ran for shorter time?). Maybe with COVID trial they should have experimented going from 3 days to 1 day dosing, rather than to 5 days?
Can't wait for New Zealand to show the leadership required on this important public health initiative (while the all talk and no action FDA require lawsuits to get them to move on menthol).
That's a great question for Leo. Do you have his email?
I hope he didn't file this topic in the building lease folder.....
Anybody attend conf call? Anyone ask a question that was answered?
Sent a note to cab-kyriakides-contact@ec.europa.eu who was referenced in the article
How the heck is Mitch Zeller still employed at the FDA?! This is leadership? On who's behalf? Sure hope XXII isn't relying on him with assurances that MRTP is coming soon.....
FDA’s continuing delay and unlawful refusal to ban menthol.
102. Meanwhile, despite Director Zeller’s reported assurance in 2013 that “there was ‘no holdup’” concerning FDA’s determination or regulation of menthol in cigarettes, FDA for the next four years (i.e., Summer of 2013 – Summer of 2017) remained largely silent about its potential regulation of menthol cigarettes.
103. Around the same time, however, many other countries began moving to ban menthol in cigarettes
104. Then in 2017, the agency finally seemed poised to take actual steps to regulate menthol cigarettes, as described below.
105. But by 2019, FDA and the other defendants had again backed away, continuing their ongoing pattern of delay and inaction on this critical public health issue.
If you haven't read the menthol lawsuit, I'd highly recommend it great entertainment! I really like this one:
"30. Defendant U.S. Food and Drug Administration (“FDA”) is the federal agency charged with regulating the marketing of tobacco products in the United States, including menthol in combustible cigarettes. By statute, FDA “shall (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner[.]” 21 U.S.C. § 393(b); see also Tobacco Control Act findings, P.L. 111–31, Div A, § 2, 123 Stat. 1776, 1780 (June 22, 2009) (noting further that FDA possesses a “mandate to promote health and reduce the risk of harm”). FDA is headquartered in Silver Spring, Maryland.
Sure seems like FDA's commitment to follow the science has boxed them in on a future low nicotine mandate lawsuit!!
https://2bark924ef5o2dk1z21reqtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/06/ASH-AATCLC-Complaint.pdf
Tobacco Companies Gave $1.5 Million to Trump Inaugural and Ramped Up Lobbying – They Want to Roll Back FDA Oversight of E-Cigarettes, Cigars
Ever wonder why Trump took mandating nicotine levels off the FDA's agenda? Follow the money as they say.
https://www.tobaccofreekids.org/press-releases/2017_04_21_trump
"The two largest U.S. tobacco companies, Altria and Reynolds American, gave $500,000 and $1 million respectively to President Trump’s inauguration, according to disclosure reports just filed with the Federal Election Commission. Reynolds is one of only a handful of companies that gave at the $1 million level."
You're correct sir this lawsuit only took 10 months!!
THE AFRICAN AMERICAN TOBACCO CONTROL LEADERSHIP COUNCIL (AATCLC) AND ACTION ON SMOKING AND HEALTH (ASH) FILE LAWSUIT AGAINST THE FDA
These folks were successful in getting the FDA to take action to ban menthol cigs. Aren't they concerned that menthol smokers will simply switch to non-menthol digs? Isn't the ultimate solution to protect smokers health to limit the amount of nicotine in all cigs to make them less addictive?
I would encourage you to send them an email (like I have), asking them to take action with the FDA compelling them to proceed with mandating low nicotine in all cigs.
https://ash.org/paths-to-zero/
Action on Smoking and Health (ASH):
tbrown@amplify.love
arendtm@ash.org
info@ash.org
https://ash.org/lawsuit-against-fda/
Go New Zealand!! Be the first country in the world to show leadership in public health by mandating reduced nicotine.
XXII here to help...
annual NZ "consumption has remained constant from 2005 through to 2008 at 2.4 billion cigarettes"
The only reason the FDA made the menthol announcement today is because they were sued and the court required a response. So who can sue the FDA to take action on mandating low nicotine? Cancer Society? Lung Association?
Rock and roll!
Have your say on New Zealand's plan to offer VLN
https://consult.health.govt.nz/tobacco-control/smokefree2025-actionplan/
Who says you need all of this market right away to be successful?! If a couple of the larger states got on board then 10% of $2 billion is a good start!! And what if even a greater %age of smokers decided to try VLN?
"a 3% market share of the smokers who attempt to quit (1.5% of the total market), the VLN franchise in 2025 would be valued at close to $2.0 billion"
Lots of foot dragging at FDA. Unable or unwilling to make cigarettes non-addictive. Time to get each state to make it happen, just like cannabis legalization.
Press release is fine and all...but I think XXII need to go to each state to obtain & implement VLN mandate....just like the feds sit on their hands while state after state is legalizing cannabis.
https://www.xxiicentury.com/news-media/press-releases/detail/423/multiple-former-fda-commissioners-voice-support-for-reduced
With a little research funding, and an effective pill, B could be well on its way to billions in sales with an effective IBD-UC treatment. Huge growth ahead:
https://endpts.com/the-ibd-market-is-set-to-soar-to-32b-abbvie-could-be-the-big-winner-but-theres-meat-left-on-the-bone-top-analyst/
This guy sure seems like he knows what he’s talking about. Sounds like everyone should be taking vitamin D supplement and maybe ivermectin (or B!).
https://www.bitchute.com/video/InH89amCpy7S/
It seems to me both cannabis and VLN mandate needs to go state by state, as FDA seems unable/unwilling to push through life saving mandates at the federal level.
Gee I wonder if South Africa might be interested in buying an effective therapuetic.....
AstraZeneca vaccine only 10% effective against variant in South Africa
Last month, South Africa halted the rollout of AstraZeneca and Oxford University’s Covid-19 vaccine after a study showed it didn’t protect against mild-to-moderate cases caused by the B.1.351 variant, which is now widespread in the country. Now we’re getting a look at the data.
While the vaccine was showing an efficacy of around 75% prior to the spread of B.1.351, a new analysis suggested the vaccine is only 10.4% effective against the variant, according to data published in the New England Journal of Medicine.
The study enrolled 2,026 HIV-negative adults, about half of whom were randomized to receive the vaccine. A total of 42 came down with Covid-19, and 39 of those cases were caused by the B.1.351 variant. Overall efficacy in this group, which consisted mostly of cases linked to the variant, was just under 22%.
“What this data don’t tell us is whether or not this vaccine might still protect at least against severe Covid-19,” Shabir Madhi, chief investigator of the study, said during a briefing last month.
Two days after halting the country’s rollout of AstraZeneca and Oxford University’s Covid-19 vaccine, South Africa’s government said it was considering selling or exchanging the doses it had already received.
https://endpts.com/covid-19-roundup-alnylam-vir-quietly-deprioritize-covid-19-drug-data-suggest-astrazenecas-vaccine-is-only-10-4-effective-against-new-variant/
XXII should follow the cannabis industry model.....start with individual states to authorize their product one by one.....don't wait for the corrupt/inept FDA or BP bought politicians to act
I thought this was very interesting. Who knows what's going on behind closed doors? Patience....... https://endpts.com/after-three-years-of-courtship-and-turndowns-merck-pounced-on-the-first-glance-of-clinical-data-in-1-85b-pandion-takeover/