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Monday, 06/29/2020 1:48:14 PM

Monday, June 29, 2020 1:48:14 PM

Post# of 30141
From Breadcrumbs To Victory


Breadcrumb #1: Dr. Gottlieb November 5th 2019

After Dr. Hahn was nominated by President Trump to be the next FDA Commissioner (replacing interim commish Dr. Sharpless), Dr. Gottlieb suggested that the support in the Senate for achieving clarity on CBD from the FDA was so strong that the Senate wouldn’t hold a vote to confirm Dr. Hahn as the next FDA Commissioner until there was some sort of guarantee that CBD clarity would be granted shortly under Dr. Hahn’s watch

https://www.politico.com/newsletters/prescription-pulse/2019/11/05/concerns-raised-about-giroir-at-fda-487593


HAHN’S PROCESS GETTING STUCK ON CBD? That’s what former commissioner Scott Gottlieb guessed could happen in the Senate. “I think the FDA’s hand is going to get forced on this. I saw it when I was there — this was a top question that came up in meetings with Congress,” he said at a briefing with reporters at American Enterprise Institute, where he’s now a fellow.It’s going to be hard to confirm an FDA commissioner without some kind of pathway on this; I think there will be holds on the nominee.”



Breadcrumb #2: Mitch McConnell January 10th 2020

Mitch is going to do what he feels is most beneficial to his own re-election

Why would he release his “B-roll” campaign video footage in January 2020 and fill 60% of it with images of hemp, if he wasn’t fully committed to fixing the Hemp-CBD issues before the election?

https://www.forbes.com/sites/tomangell/2020/01/10/watch-mitch-mcconnell-frolic-in-a-field-of-cannabis/#3f2855086d9a


Making hemp the centerpiece of his campaign, while leaving the Hemp and CBD industry in its current state of legal and regulatory limbo, is certainly not to his benefit

Mitch is an incredibly shrewd tactician

He is a true legislative maestro, often playing chess while others are playing connect four

Mitch ultimately controls the exact timing of legislation moving through the Senate, and that includes the Covid-19 Phase Four Stimulus Bill and any Hemp/CBD legislation attached to it



Breadcrumb #3: Dr. Hahn February 26th 2020

This was the moment the FDA publicly signaled a turn in their stance on OTC sales of CBD in America

https://cannabiswire.com/2020/02/27/fda-to-ag-regulators-fools-game-to-tell-americans-they-cant-use-cbd-products/


Hahn, sworn in as FDA commissioner in December, asked the attendees how many people went through Reagan National Airport, and came upon a store that has a “huge stand for CBD products.”

“So, we know one thing from the American people: they’re using CBD products,” Hahn said.
Hahn went on to tell a story about a patient who texted him to say that they were using CBD oil as part of a broader cancer treatment.

“We’re not going to be able to say ‘you can’t use these products,’” Hahn said. “Even if we did, it’s a fool’s game to even try to approach that.
But what do we need to do? We need to fill the information gaps. We need to understand what it helps with, because we have some evidence on the drug side that it may be beneficial.”

Hahn then asked, referencing the proliferation of popular non-pharma CBD products, which are not yet FDA-approved, “What about on the other side of the fence? Where could it be of benefit? FDA has spent a lot of time looking at this. We are trying to formulate what our stance is going to be on this. It’s an important time for FDA to really communicate with the American people about what we think is a risk, versus what we’d like to study further and look at. Because I think we have to be open to the fact that there might be some value to these products. And certainly Americans think that that’s the case.”



Breadcrumb #4: Dr. Hahn March 11th 2020

Two weeks after Dr. Hahn sent his first signal to the public that OTC sales of CBD have a bright future in America, he admits for the first time that the FDA is working with the White House to provide long-awaited clarity on CBD within “the next few months”:

“It’s taken us a bit of time within the agency to get to this point. I’m pretty comfortable that we’re going to work forward in the next few months to actually get this. We’re working through the process within the department and The White House to get to that point.”

— March 11, 2020

https://www.marijuanamoment.net/fda-chief-faces-cbd-questions-at-congressional-hearing/



Breadcrumb #5: Cory Gardner February 25th 2020

Senator Cory Gardner of Colorado reported in late February that a compromise version (not the House version that already passed in Sept 2019) of The SAFE Banking Act would be ready to be voted on “in a matter of months” — that’s a pretty similar sounding timeframe to Dr. Hahn’s March 11th statement about the FDA being ready to provide clarity on CBD “in the next few months”

So now we are looking at similar timetables for Hemp Banking to pass the Senate and the FDA to announce a formal policy of Enforcement Discretion for CBD products


https://www.marijuanamoment.net/deal-on-marijuana-banking-bill-is-close-gop-senator-says/


Gardner said that he, Crapo and Sen. Jeff Merkley (D-OR) have “made great progress on the details of the SAFE Banking Act.”

“We are working through some of the objectives Sen. Crapo has in terms of safety, research, and guidance. We’re doing it in a way that respects state’s rights, that respects the voters of the states, that moves forward on this,” he said. “I believe that in a matter of months we can have a vote on a compromise version in the Senate that will have the support of 60-plus of my colleagues and of the House of Representatives.”



Breadcrumb #6: Jonathan Miller March 2nd 2020

Less than one week after Senator Cory Gardner pinpointed the May/June timeframe (“matter of months” after February 25th) for the passage of Hemp Banking through the Senate, we got corroboration from another very well placed source — Mitch’s personal Hemp lobbyist Jonathan Miller, who is the only person in the media to successfully predict the filing of HR 5587 — that the date for passage of the Senate’s version of The SAFE Banking Act would occur “in the Spring”

So now we have 2 separate sources (Gardner and Miller) converging on the same timeline for the passage of Hemp Banking through the Senate — May/June 2020

Remember, at this point in time in late February and early March, we are still pre-crisis in terms of Covid-19 and it appeared that the plan was to pass The SAFE Banking Act as a standalone piece of legislation through the Senate and attach CBD Legalization to it

https://hempsupporter.com/news/movement-on-safe-banking-act


As we shared last fall, the SAFE Banking Act – originally focused on marijuana commerce only – was amended to provide a clear safe harbor for hemp banking, and it passed the U.S. House by a more than 3 to 1 margin. For months, unfortunately, it has languished in the Senate.

However, our lobbyists report that there is movement, and we expect the Senate Banking Committee to finally mark up the bill in the spring.



Breadcrumb #7: Epidiolex Descheduled April 6th 2020

Though Congress removed Hemp-derived CBD from the Schedule of Controlled Substances thru The 2018 Farm Bill, Epidiolex (Prescription form of CBD) remained as a Schedule 5 controlled medication, which is where the DEA placed it in September 2018— FDA had argued to deschedule it, but DEA insisted that was not legally tenable, as CBD remained on the UN list of controlled substances and America would be violating international drug treaties if Epidiolex was descheduled

So the DEA still considered CBD a controlled substance — this is something that had remained a hurdle for the OTC CBD industry, because it placed Prescription CBD on a far more restrictive level than OTC CBD, which is inherently unfair to GW Pharma, the makers of Epidiolex

So it is very surprising that the DEA took this step — it was not expected to happen at all until the UN descheduled CBD first

Now Epidiolex is just as accessible as any other garden-variety prescription medicine

So why did the DEA all of a sudden have a change of heart?

The most logical explanation is that the DEA is now expecting OTC CBD to be legalized and available nationally within the near future, and they would in effect be punishing GW Pharma and Epidiolex users if they left it on Schedule 5

In other words, if OTC CBD products are about to become far more accessible to Americans due to legalization and enforcement discretion, which would result in national sales, then Epidiolex should receive the same treatment, and descheduling it will make it a more popular medicine amongst prescribers, who will now be able to prescribe it for “off-label” indications beyond 2 rare childhood seizure disorders — so now Epidiolex will be more accessible for patients with other medical conditions, such as non-pediatric seizure disorders and diabetic neuropathy


https://www.marijuanamoment.net/cbd-prescription-drug-is-no-longer-a-federally-controlled-substance-dea-says/


CBD Prescription Drug Is No Longer A Federally Controlled Substance, DEA Says

The Drug Enforcement Administration (DEA) has removed a marijuana-based medication from the list of federally controlled substances.

GW Pharmaceuticals announced on Monday that Epidiolex, a prescription drug it developed that’s derived from cannabis and used in the treatment of epilepsy, had been taken off Schedule V of the Controlled Substances Act. Effectively immediately, the CBD medication is no longer a controlled substance, the company said.

That means individuals will be able to more easily obtain Epidiolex. GW said in its notice that it will “begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.”



Breadcrumb #8: Jonathan Miller April 8th 2020

Jonathan Miller announces that there will be a strong push to include CBD Legalization in Foods/Beverages/Supplements as well as Hemp Banking in the Phase Four Covid-19 Economic Stimulus Bill

12:30-17:10 provides the most important information and is well worth a listen

From 15:15-15:53, Mr. Miller states the real crux of this situation:

“FDA relief for our industry directly deals with the economic recovery from this Covid-19 crisis.
If we can get FDA relief, it will unleash the CBD business, allow for sales of many more products without this cloud, we think the big box stores will allow these sales.
We think Cola companies and other big food companies will want to put CBD in their products, which most importantly creates new markets for hemp farmers.
We are really hopeful that Congress will agree that this is part of the economic recovery and that they will have an amendment to the Stimulus Four package to require the FDA to regulate CBD and to unleash this industry and the economic boost to the economy that would happen.”


https://www.facebook.com/2043552242529673/videos/517338882233397/



Breadcrumb #9: Nancy Pelosi April 9th 2020

Nancy Pelosi Wants Marijuana Banking Access Included In Next Coronavirus Relief Bill, Congressman Says

https://www.marijuanamoment.net/pelosi-wants-marijuana-businesses-included-in-next-coronavirus-relief-bill-congressman-says/



Breadcrumb #10: Trump’s Executive Order on Regulatory Relief to Support Economic Recovery May 20th 2020

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155764067



Breadcrumb #11: Jonathan Miller Suggests FDA Emergency Regs For Sale of CBD as Supplement and Food via Trump’s Executive Order June 4th 2020

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=156296047



Breadcrumb #12: Canopy Growth Plans US CBD Beverages Launch in 2020 June 22nd 2020

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=156467566


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