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"we apologize for the fda sending warning letters out to our competitors"
i got a few theories
1. if the sec case is not resolved before June 30, 2018 then no r/s or uplist or registered offering.
2. i think they knew the sec case was coming and needed to come frankly before they could get in bed with an legit investment bank.
3. the royalty on cvsi-007 had to be cleared up also before they could get in bed with the investment bank.
4. they have talked with the fda about the consumer division; and the fda said well we dont want to talk to you but eventually we will have to talk to you and you are going to help us get this figured out. there will be a system put in place where you will have to pay to play; whether that is through self affirmed gras or something else. the little guys are going to be booted out.
5. fda sending a letter to cw means the fda really doesnt care for cw (marketing cbd for dogs is illegal (cw is doing this))
6. fda is watching every step this company and others is making. especially the market leaders; the fact that they did not get a letter means they have been very disciplined and know exactly what they are doing.
AIBMR Life Sciences, Inc. (a highly respected scientific and
regulatory consulting firm specializing in GRAS Self-conclusions, FDA GRAS Notifications, FDA NDI Notifications as well as toxicological studies that was founded in 1978.)
im basically calling anyone selling today an idiot not because they sold but because they havent sold sooner considering the warning letters sent in 2015 and 2016 and the fda q and a regarding marijuana that has been up for over a year and a half
do your research folks
cvsi market cap is now below cvsi revenue and we are in one of the fastest growing industries in the world; wow
panic selling because of the warning letters
market leader Charlottes Web gets a warning letter
read posts to understand the situation:
#10749 -> read this one most important
#10748
#10747
#10746
#10745
my mistake was thinking people understood this. clearly with all the sellers they did not.
I have been bringing up this issue on the this board for a while geesh.
its hard to judge how clueless the market is at a given point to time correct entry points. clearly the market is as clueless as ever and didnt realize the exact same warning letters were sent in 2015 and 2016 and the fda q and a regarding marijuana has been up for nearly a year and half.
nothing new here folks
good article to explain timeline; dont think those included stops in federal court [this one will if needed]:
http://www.kkblaw.com/lessons-from-red-yeast-rice-factors-to-consider-regarding-fdas-position-on-cbd-supplements/
then here is the cvsi response to the fda feb 2016 where they begin to build the case and attack the timeline of the "substantial clinical trials":
https://www.newcannabisventures.com/cv-sciences-responds-to-fda-warnings-issued-to-8-marketers-of-cbd/
then the "gras" section read page 23 question 2:
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf
2. Am I required to submit an NDI notification for a dietary ingredient that is an NDI, but has been (a) listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food or (b) approved as a direct food additive in the U.S.?
No, as long as the following conditions are met....[read the rest]
Are you confused yet? We still arent done. There is a little thing called the Sherman Act of 1890:
As explained by the U.S. Supreme Court in Spectrum Sports, Inc. v. McQuillan 506 U.S. 447 (1993):
The purpose of the [Sherman] Act is not to protect businesses from the working of the market; it is to protect the public from the failure of the market. The law directs itself not against conduct which is competitive, even severely so, but against conduct which unfairly tends to destroy competition itself.
So does giving the pharmaceutical industry a MONOPOLY over the natural product industry destroy competition unfairly? How can cbd oil from hemp flower have been expected to be marketed as a dietary supplement when per the DEA it was illegal. Perception is reality and DEA sabre rattling prevented cbd oil from being marketed before "substantial clinical trials" regardless of the true legality of cbd oil from hemp flower.
The FDA will come in say; well we are protecting the market.
But if it is self affirmed GRAS (Generally Regarded as Safe) that argument holds no water. The product is safe the public does not need protection; at least from pluscbd that is. cant vouch for the rest.
SEE YOU IN FEDERAL COURT
Yep this is the 3rd round of letters. Plus cbd has never received one.
Prior cases where the FDA "won" it took 4 and 3.5 years respectively for the issue to be resolved and the dietary supplement stayed on the market during that time. And we are at least 2 years probably from the potential "start". And then what do they do file against every maker or just the top few? This is a complicated situation for all involved. The cbd industry is becoming so big so quick it will be very hard to shut down without huge commitment from D.C. one would think.
Technically per the Dietary Supplement Health and Education Act of 1994 (DSHEA) yes.
In reality see you in federal court.
It's complicated.
Cvsi has commented a few times and they had a few responses march 2016 regarding.
Red yeast rice is the case precedent or as close to as possible and that took years to resolve
There are antitrust those issues no one is bringing up though namely how can the free market be expected to market something that was illegal per the dea; whether it was or not is irrelevant. The perceptions perpetuated by the dea was he reality. I say this because some argue that hia vs dea case law 2004 legalized hemp cbd oil that is imported.
They are goin for self affirmed GRAS won't be on fda website
precisely; nothing new though there:
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm
one would hope the consumer division stays alive long enough to get the pharma division going
just not sure how long the consumer division can stand up to hostility from the fda; i thought gras got them past but not so sure now.
good luck to all!
i wonder if they just erase all claims of medical efficacy and call it good and see what the fda says; the fda did go into much more in the letters but if they wouldnt have had the medical claims it seems like the letters dont get sent out which is why +cbd didnt have any problems this round.
they just got the letter so they have 15 days; no defiance yet.
tough decisions for cw coming up especially with no *potential* gras in their pocket like cvsi.
this happens to cvsi they have a little more firepower.
only 4 letters sent out so cvsi did not get one
as i have been saying cvsi is a very disciplined and well managed outfit
charlottes web has been sloppy all over the place
if gras gets you past the fda (not sure if it does or not) this company will be bought out for 2 billion. mark this post.
cw keeps their website up in defiance of fda wow
what the heck is going to happen here?
from the CW letter:
"...are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]..."
Well pluscbd may have the gras solved not sure. wish i knew an expert fda lawyer.
ouch new round of warning letters mailed out
market leader charlottes web on the list wow
no change except dates are now set for pretrial.
i did notice quite a bit of selling though; not sure if someone saw something.
If I had to guess we are looking a trial for next summer but could be much longer. not familiar with timeline on how these things usually go.
more sellers and a new bottom.
not looking good here.
thc is bad mmkay
if you want to actually heal yourself and improve yourself cbd is so much better; it has none of the up and down fluctuations of thc and has none of the the "munchies" or uncontrollable urges.
absolutely a miracle product.
this thing has a potential to explode.
A few things re:Canada:
1. Canada cannot export to US. [see recent ruling by canadian exchanges]
2. Illinois+Minnesota+Michigan is a a bigger economy than Canada.
3. California by itself is bigger than Canada.
4. HR3530 has 17% chance of passing [that is very high for congress bills] and it would remove cbd oil from the CSA "officially" which in my opinion is better than the "real" thing because it gives you all the good effects but none of the wild fluctuations; "munchies" or lack of control. Consumers just need the price to come down. Don't believe me? Take some of the cbd concentrates by pluscbd. Amazing product just expensive.
5. Canada stock leaders are selling near 1 billion dollar market cap.
6. US stock leaders are selling at 1 or 2x revenue. [justified yes the home runs are harder and harder to find in Canada].
7. Canada taxes are out of control and possibly the worst in the world.
INSY halted! people that actually think cvsi would get halted over an alleged accounting fraud that was FIXED 3 years ago are ridiculous.
a little dead cat bounce this morning yay?!?
in all seriousness though if this thing ever runs its going to run like crazy
Talked to the mgr; someone from corp got spooked; she seemed hopeful it would
Be back and sent me to the another store nearby that has it. One of the considerations is whether they lock it down or not. The other is legality.
n-g panicked and pulled
there are 4 stores in my area that i know of (midwest) now that sell pluscbd
how the hell is this stock at a 19 million dollar market cap
what i am missing?
cvsi revenue is 2 million below aurora (acbff OTC) on a quarterly basis yet the market caps are separated by 820 million.
cvsi potential clients is 300 million more people compared to aurora.
https://www.newcannabisventures.com/cannabis-company-revenue-ranking/
All the top canadian stocks are trading near a billion dollar market cap
the top usa stocks are trading for 1 or 2x revenue.
this market has left reality.
california by itself is a bigger market than canada.
canada taxes are out of frickin control.
wow cant even hold .22
see this is why you dont make sense
you keep talking about everything but what matters which is market cap
this is a 20 million dollar stock
do you expect a public company with nearly 17 million revenue to trade for 10 million? 5 million?
so the whole after rs thing makes zero sense
lets talk market cap here because the rest is irrelevant
trtc trades for 121 million
mjna trades for 221 million
there are canadian mj stocks trading for 1 billion (aurora cannabis etc)
Canada has 30 million people; usa has 330 million people
trtc product is confined to Nevada and cali; both excellent places to be confined to and bigger markets than Canada but cvsi product is in all 50 states
even a descheduling means now the fda has jurisdiction over mj
so you say after the rs but that makes no sense
this needs to be a market cap discussion
decheduling only gets you past the dea not the fda
cvsi has a path past the fda as i have explained many times
all other stocks are currently confined inside state borders
it trading at nearly 1x revenue in a very fast growing sector
not sure this can go much lower
you must be loading ap; i get it
key announcement coming from cvsi; "exciting news"
not sure what it is any ideas?
could be new product line
"broaden our category"
could be something we already know too not sure
pretty much the exact quote from earlier this month i stumbled across:
"real exciting news; and a key announcement that will be coming very soon that will broaden our category and demonstrate that demand for this ingredient and products are real and here to stay"
i personally think its something we already know but not sure
yes it is in purgatory; trying to figure out if this thing will go to trial or get settled. if it goes to trial this is going to drag out for years one would think.
any thoughts now that this case has developed a bit?
Not sure why they mentioned Paul Hastings in their release; he is not listed as an attorney on the case.
Is this guy a big deal or something?
Maybe he is calling the shots in the background?
updated status:
NOTICE of Hearing: A Scheduling Conference is set for 10/30/2017 at 9:15 AM in LV Courtroom 3B before Magistrate Judge Peggy A. Leen, regarding the parties' 22 Stipulated Discovery Plan and Scheduling Order.
Out-of-state counsel may participate telephonically by contacting Courtroom Deputy Jeff Miller at (702) 464-5420 before 4:00 p.m. 10/26/2017, to indicate the name counsel who will be participating and a telephone number where counsel may be reached. The courtroom deputy will initiate the call for the hearing. (no image attached)(TKH) (Entered: 10/19/2017)
canada corps told to get back behind the border
aurora trying to get into the hemp cbd business bad news for them
good news for us based hemp cbd companies
im surely missing something here