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remember from the july shareholder meeting scoop:
when cvsi had its pre-ind meeting with fda in june 2017 they mentioned that the head of every department in the fda came to the meeting and seemed very interested.
now its starting to make sense and the fda and cvsi could have a mutually beneficial relationship.
cbd gum mainstream!? what is cbd again? its a neuroprotectant and anti-inflammatory. negates negative effects of nicotine?
"At the same time, FDA is taking new steps to facilitate innovation in products that can deliver satisfying levels of nicotine to adults who want or need such access without the same health risks associated with combustible tobacco."
How the FDA may regulate CBD market(see REQUIRE... below):
FDA continues to take steps to improve its oversight of food safety. To address critical issues related to the overall safety of the food we eat, FDA intends to propose a rule on lab accreditation, which would establish a program to accredit labs to do food safety testing and to REQUIRE that these accredited labs be used in certain situations.
Additionally, in the Unified Agenda, FDA committed to pursuing a rulemaking that will clarify registration requirements for food facilities to better align how facilities and farms that perform similar activities are treated under the preventive controls rules and the produce safety rule.
https://blogs.fda.gov/fdavoice/index.php/2017/12/looking-ahead-some-of-fdas-major-policy-goals-for-2018/
Also another potential direction:
Broadening Access to Nonprescription Drugs: We are considering innovative action in the nonprescription drug area to expand the scope of drug products that can be made available to consumers without a prescription. We will be proposing to allow certain innovative approaches for demonstrating that a drug product can be used safely and effectively in a nonprescription setting. This will allow some drugs that would otherwise require a prescription to be marketed without a prescription through the use of innovative technologies and other conditions that will ensure appropriate self-selection and/or appropriate actual use of the nonprescription drug product by consumers. Examples of such conditions could include use of self-selection questions on a mobile medical app prior to permitting access to the drug, or other innovative technologies to improve safety. Through use of these types of additional conditions, we hope to create a new paradigm of drug safety with greater flexibility that will benefit patients and public health. We are committed to advancing this new framework to enable a potentially broader selection of nonprescription products for consumers, empowering them to self-treat more common conditions and chronic conditions. This also could help lower costs by increasing the availability of products that would otherwise be available only by prescription.
https://blogs.fda.gov/fdavoice/index.php/2017/12/looking-ahead-some-of-fdas-major-policy-goals-for-2018/
and this is a snippet from the Wisconsin bill that just passed and rumours Indiana could have something similar in their new bill:
(9) TESTING OF INDUSTRIAL HEMP INTENDED FOR CONSUMPTION. (a) All industrial hemp and each industrial hemp product intended for human consumption shall be tested, in its final consumer-ready state, by an independent testing laboratory to confirm that it is nonpsychoactive and contains safe levels of potential contaminants.
An independent testing laboratory shall have all of the following:
1. Accreditation by an impartial organization that provides accreditation pursuant to the standard ISO/IEC 17025 of the International Organization for Standardization and that is a signatory to the International Laboratory Accreditation Corporation Mutual Recognition Arrangement, or other comparable accreditation standard required by the department....
FDA #1 policy goal is address nicotine addiction crisis:
https://blogs.fda.gov/fdavoice/index.php/2017/12/looking-ahead-some-of-fdas-major-policy-goals-for-2018/
HERE WE GO!
here is a new little nugget:
"The Company will additionally feature its brand of practitioner-exclusive products available only to healthcare providers nationwide."
Here we go folks! Cant wait to see what the new product are!
precisely; cbd is gonna be huge!
look how the narrative that will be used by the FDA is being shaped:
https://www.ncbi.nlm.nih.gov/pubmed/28707583
so here is the conundrum; the hemp extracts are working better than the isolated or synthetic cannabidiol.
so is cvsi-008 really just the hemp extract that they will have to get standardized enough to submit to the FDA for clinical trials?
If they walk up to the FDA and say hey we have self affirmed gras and a WHO report that this can help with cancer etc. that may allow cvsi to fast track their hemp extract for all sorts of things and the FDA will mostly likely need to work with someone because of such high public demand for this. But of course the FDA wants control.
that texas bill is junk
sonny perdue head of usda on hemp:
“The challenge is state-level regulation,” Perdue said. “It’s very similar to a nonindustrial product (marijuana). I think you’ll see the rules continue to be relaxed. Agriculture needs to have new, innovative products.”
http://www.lancasterfarming.com/news/farm_policy/ag-secretary-hears-concerns-from-upstate-farmers/article_b84d82ae-cbc3-11e7-ba33-ffe6fd48dfe0.html
the self
affirmed gras would be the golden ticket to get at least a really good head start.
i think they have spent millions and at least a few years trying to get it.
so the fda could give cvsi a year or two head start which would be huge.
oh an if you like xxii scott basically said blah. so ya investing in low nicotine products may not be a good idea. He is basically like lets just get people off nicotine period. this is 1 or 2 on the fda's priority list is to get the public off nicotine.
lots of talk about getting the public off nicotine by the industry today at duke health policy forum
they alluded to products like cvsi-007 many times!
Here we go folks!
i think cvsi is very quickly trying to figure out how they get can their formulation so standardized but still aquire from agicultural hemp so they take that formulation that is working better than anything pharma can offer so far (including epidiolex) that they just submit to FDA for testing cancer etc etc etc. That is the thing. The stuff from ag hemp for cbd is working better than the lab forumulations because of the entourage effect. This is a wild situation. Now the kicker is that cvsi is trying to get self affirmed gras on their product; this would be huge could allow them to fast track through the fda. All the fda is saying on repeat is that we need to address the opiod and nicotine/tobaaco crisis (they are saying both) and we need new medicines and we need to fast track those. See what I am getting it. If cvsi can make friends with the FDA then the FDA can say see we found a friend SCREW EVERYONE ELSE that doesnt want to be our friend we are shutting this shit down. Our friends at cvsi were so kind to get a gras on their exact formulation so now we gonna fast track this and SHUT THE REST DOWN. You can take this product for your cancer and depression and anxiety etc etc.
what they will do with high thc marijuana is say its phychoactive and habit forming and they are going to SHUT IT DOWN if there is not enough congressional support to get past the FDA. So watch what you wish for if you are invested in recreational marijuana. Medical marijuana and will not exist eventually imo and be handed to pharmaceutical companies. All medical formulations will be forced to go through the FDA no wiggle room. That is why hemp cbd oil will only be able to be advertised as a dietary supplement not a medical formulation if its sold off the shelf. Eventually you could see cbd oil approved as an otc drug but that could be a while from now.
the WHO report signals that we are looking at a situation where artisanal high cbd hemp oils (maybe up to 49% cbd) will be allowed if they are sourced from agricultural hemp. All else will be handed to the pharmaceutical industry for medical formulations. They will likely put a kibosh on cbd isolates. CBD affects what keys do when they turn the lock so the possibilities on the medical side will be endless. I expect that the kibosh will be put on adding isolated cannabidiol to other ingested products.
Lots to work out here over the next 5-10 years in this new section of life science industry.
There is no urgency for the FDA to protect the market from a safety issue; and acting could setup a problem for them if they over reach.
Marijuana being confined to the states is protecting it from the FDA/Pharmaceutical take over. You need congressional support to get it past the FDA which marijuana does not have. Agricultural hemp (cannabis under .3% thc) will most likely be descheduled first. Then they will have to go fight the FDA but the fight will be much easier because the the lack of psychoactivity and intoxication from cannabidiol. The THC in agricultural hemp is determined to be in trace amounts so it will be able to much more easily pass the FDA.
The point is; be careful what you wish for.
Think of it this way:
THC literally turns the key on the lock of the door (in your body).
CBD simply attaches to the lock of the door but effects what the keys do when they are turned.
The FDA is already setting up the legal case because of the phychoactivity of THC that they want to give a monopoly for marijuana/high thc cannabis to the pharmaceutical industry.
They are certainly trying to do the same with cbd/agricultural hemp but the argument is so much weaker due to lack of psychoactivity and intoxication from Agricultural Hemp/CBD Oil. Also Big Ag/Farmers are saying hell no to the FDA. The marijuana industry doesnt have farmers; they have indoor high carbon foot print grows.
low volume runs are seemingly possible when before with iliad dilution so strong they were not
last warning or banhammer is coming
***interesting times***
we also have the goodlatte swan song here; and he aint going to work for another industry folks
rumour is that mcconnell has something up his sleave
change of plans christmas is back on
there is a new sheriff in town
hr3530 38 cosponsors and senate bill coming...
big money moving in; retail money moving out
here we go folks
this thing is generating cash!
the glass ceiling is being removed as we speak (iliad)
dilution is for the most part is over it appears besides the options
ILIAD 2 GOING DOWN! HERE WE GO!
"After payment of the December 2017 installment, the amount remaining due under the Note is approximately $612,100. The Company will continue to utilize cash flow in a manner that puts the interest of stockholders first, both in terms of continued growth and managing dilution."
hmmm; wonder if the market was reacting to that.
are they ditchin mona and going after the auditor?
I think the SEC is having a hard time proving that Mona intended to gain or had something to gain out of the Phytosphere transaction.
Phytosphere looking back was really worth 35 mil and then some.
Holy cow having the Europe connection is allowing them to kill it.
If you go after the auditor you just need to prove negligence not actual fraud I think.
institutional buyers starting to move in
panagora asset management pick up 143k shares last quarter
2 billion market cap or bust is my plan
tail winds are starting to develop here
many many things going on here
this thing it setting up for a huge move in 2018
HATERS GONNA HATE!
here is the report for those interested. I am told it is a prelim report on cannabidiol:
http://www.who.int/medicines/access/controlled-substances/5.2_CBD.pdf
Favorable report by WHO on cannabidiol.
No red flags that I could see.
its important to notate now 4 different sub sectors in the USA developing for the sale of actual cannabis products:
1. Recreational Marijuana in individual states
2. Medical Marijuana in individual states
3. CBD Oil from Agricultural Hemp
4. Pharmaceutical
Keep in mind #3 and #4 are national plays. CVSI is working on both. They are going to go wherever the market allows them to go.
Very good plan so far!
WISCONSIN passes new Hemp bill unanimously. The governor has signed it. This is a purple state that was a key cog in getting Trump elected. The bill seemed very pro CBD and CBD Oil from Hemp. Specifically mentions this:
(d) That cannabidiol and hemp seed oil have the ability to provide relief for more maladies than medical marijuana, without psychotropic effect.