DarthYoda
3 days ago
"Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority":
Jul 01, 2024
In overruling Chevron on Friday, the Supreme Court ushered in a new framework, dubbed Loper Bright. Courts are now required to “exercise their independent judgement in deciding whether an agency has acted within its statutory authority” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
This new framework could have significant consequences for the FDA and its regulatory authority, according to an analysis by global law firm Sidley.
The firm contends that Loper Bright could potentially open the regulator’s drug approvals to legal challenges. Companies need to provide “substantial evidence” that their drug candidates are safe and effective before securing approval, but courts in the past have found this ambiguous and have allowed the FDA to ask for additional requirements, such as data showing that the candidate’s effects are clinically meaningful, according to Sidley.
Under Loper Bright, more companies could try and challenge this approach, Sidley warned.
The overturning of Chevron could also pose some jurisdictional questions for the FDA, which is typically given the leeway to decide what constitutes a dietary supplement or a device product. These kinds of determinations affect how products are regulated, produced, or imported—and companies can now mount stronger challenges to this function by the FDA.
https://www.biospace.com/article/supreme-court-s-chevron-doctrine-ruling-could-limit-fda-s-regulatory-authority/
Here are two opposing opinions on how the chevron decision could affect rescheduling...
https://www.marijuanamoment.net/the-supreme-court-nuked-cannabis-rescheduling-with-its-chevron-ruling-op-ed/
https://www.marijuanamoment.net/reports-of-marijuana-reschedulings-chevron-related-death-are-greatly-exaggerated-op-ed/
Wolf-man jack
3 weeks ago
In my opinion, It doesn’t appear that BAT is investing in OGI and CWBHF for any other reason, but to make sure their investments are protected. Most likely there would be no mergers planned for the two entities along with BAT. Poison pills 💊 in both agreements. But agreements can be negotiated for any and all reasons as long as both parties agree. The recent tranche of funds for the Jupiter program of acquiring other cannabis companies could prove me wrong. With the limited amount of funds available, they are considering smaller companies. Unless, they offer equity and stock for any possible acquisition of CWBHF by OGI.
“ BAT will subscribe for 12,893,175 million shares on the closing of the first tranche (currently expected to be on or around January 16, 2024) for gross proceeds of C$41.5 million with the remaining 25,786,350 shares to be subscribed for in two further equal tranches on or around August 30, 2024 and February 28, 2025.
To the extent BAT exceeds 30.0% holding of outstanding Common Shares, it will be issued non-voting Class A convertible preferred shares ("Preferred Shares"). Accordingly, in aggregate, based on Organigram’s current 81,161,630 Common Shares outstanding, 12,999,231 Common Shares will be issued, and the remaining 25,680,294 shares will be initially issued as Preferred Shares. The Preferred Shares will be eligible for conversion into voting Common Shares at BAT’s option, provided that such conversion would not result in BAT’s voting interest in the Company exceeding 30%.
In connection with the closing of the first tranche of the Investment and subject to approval by Organigram’s shareholders, the Company will file articles of amendment to create the new class of Preferred Shares to be issued to BAT in the Investment.
Class A Preferred Shares
Each Preferred Share shall be economically equivalent to a Common Share and will be convertible into Common Shares at the option of BAT without payment of any additional consideration. The conversion ratio shall initially be one-for-one, and post-issuance shall increase at a rate of 7.5% per annum, compounded annually, until such time as the Preferred Shares are converted into Common Shares or the aggregate equity interest of BAT in Organigram (inclusive of both the Common Shares and Preferred Shares as if converted into Common Shares) reaches 49%. BAT shall be periodically required to convert Preferred Shares to the extent that it holds less than 30% of the Common Shares outstanding”
Wolf-man jack
3 weeks ago
“Investor Rights Agreement, dated November 14, 2022, by and between Charlottes Web Holdings, Inc. and BT DE Investments, Inc. a wholly-owned subsidiary of BAT Group“
https://contracts.justia.com/companies/charlottes-web-holdings-inc-14559/contract/261689/
“ Since March 2021, Organigram’s partnership with BAT has gone from strength-to-strength, most significantly the progress achieved as part of the PDC agreement.”
https://finance.yahoo.com/news/organigram-announces-c-124-6-110000751.html
“BT DE INVESTMENTS INC. ACQUIRES STAKE IN CHARLOTTE'S WEB HOLDINGS, INC.
NEWS PROVIDED BY
BT DE Investments Inc.
Nov 15, 2022, 08:19 ET
WILMINGTON, Del., Nov. 15, 2022 /CNW/ - BT DE Investments Inc. (the "Purchaser") announced today that it has acquired (the "Transaction") C$75,341,080 aggregate principal amount of a 5.00% senior unsecured convertible debenture due 2029 (the "Convertible Debenture"), which is convertible, in whole or in part, at any time and from time to time, into 37,670,540 common shares (the "Common Shares") of Charlotte's Web Holdings, Inc. (the "Issuer") at a price of C$2.00 per Common Share (the "Conversion Price"). The Convertible Debenture provides for the adjustment of the Conversion Price in certain customary events. The Purchaser is a wholly owned indirect subsidiary of British American Tobacco p.l.c.
Immediately prior to the Transaction, the Purchaser did not have beneficial ownership of any securities of the Issuer. Immediately after the Transaction, and assuming the conversion of the Convertible Debenture in full, the Purchaser acquired beneficial ownership of 37,670,540 Common Shares, representing approximately 19.9% of the issued and outstanding Common Shares (calculated on a non-diluted basis).”
“ The Purchaser entered into the Transaction as part of an investment in the Issuer and intends to review its investment in the Issuer on a continuing basis. The Purchaser may, subject to the terms of the investor rights agreement entered into between the Purchaser and the Issuer dated November 14, 2022, depending upon a number of factors including market and other conditions, increase or decrease its beneficial ownership, control, direction or economic exposure over securities of the Issuer.”
https://www.newswire.ca/news-releases/bt-de-investments-inc-acquires-stake-in-charlotte-s-web-holdings-inc--851723097.html
This statement would allow BAT to bring OGI and CWBHF together as a merger opportunity. Depending on the BAT and OGI agreement, which I haven’t researched, then BAT may be able to bring both entities under the BAT Umbrella.
“ The Purchaser may not convert the Convertible Debenture, in whole or in part, if and to the extent that, as a result of such conversion, the Purchaser would beneficially own or exercise control or direction over in excess of 19.9% of the number of Common Shares outstanding immediately after giving effect to such conversion.”
Wolf-man jack
3 weeks ago
WQLF SAYS; It there is a likelihood of a Merger, it would be OGI acquiring CWBHF. This would be more feasible if BAT converts CWBHF debt into CWBHF Equity / shares. This would allow more leverage for shareholder approval of any M&A between OGI and CWBHF. If CWBHF sales continue on their current downward trajectory, and the continuation of large increases in Cash burn, then the merger and acquisition will have to go into effect. The lower the price per share of CWBHF will benefit OGI and BAT. In my opinion, the current and future CWBHF shareholders will be the losers in the long run if this is what BAT has in mind. The bottom price per share of CWBHF in the near future could end up between 10 and 15 cents.
“ Most of the money will be used by Organigram to fund a strategic investment pool named Jupiter, which will target investments in emerging cannabis markets.”
https://mjbizdaily.com/tobacco-giants-124-million-investment-in-marijuana-firm-organigram-approved/
CWBHF
Balance Sheet
Total Cash (mrq) 38.51M
Total Cash Per Share (mrq) 0.25
Total Debt (mrq) 60.14M
Total Debt/Equity (mrq) 128.86%
Current Ratio (mrq) 3.48
Book Value Per Share (mrq) 0.30
cashbyers
4 weeks ago
Don’t overlook this undervalued synergy!
British American Tobacco already has existing deals with both Charlottes Web Holdings $CWBHF and Organigram Holdings $OGI… There are a few possibilities for how BAT could leverage its partnerships with both companies:
Joint Investment: BAT, Charlottes Web, and Organigram could collaborate on a joint venture or even a merger (depending on regulations) to create a larger cannabis and CBD company. This would require significant planning and navigating potential regulatory hurdles.”
Market Expansion: BATs global reach could be valuable for both Charlottes Web and Organigram. BAT could help them enter new markets where cannabis or CBD products are legal. For example, BAT might leverage its existing distribution channels for these products.
Knowledge Sharing: BAT could act as a bridge between the two companies, facilitating knowledge sharing and best practices in areas like marketing, regulatory compliance, and cultivation techniques.
oystersnbeer
2 months ago
US drug control agency will move to reclassify marijuana in a historic shift
The U.S. Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug, The Associated Press has learned, a historic shift to generations of American drug policy that could have wide ripple-effects across the country.
The DEA’s proposal, which still must be reviewed by the White House Office of Management and Budget, would recognize the medical uses of cannabis and acknowledge it has less potential for abuse than some of the nation’s most dangerous drugs. However, it would not legalize marijuana outright for recreational use.
The agency’s move, confirmed to the AP on Tuesday by five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review, clears the last significant regulatory hurdle before the agency’s biggest policy change in over 50 years can take effect.
Once OMB signs off, the DEA will take public comment on the plan to move marijuana from its current classification as a Schedule I drug, alongside heroin and LSD. It moves pot to Schedule III, alongside ketamine and some anabolic steroids, following a recommendation from the federal Health and Human Services Department. After the public-comment period the agency would publish the final rule.
Read more: https://apnews.com/article/marijuana-biden-dea-criminal-justice-pot-f833a8dae6ceb31a8658a5d65832a3b8
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