White House Office of Management and Budget review on Cannabis-Derived Products confirms Rapid Therapeutic Science Laboratories’ Long-Term Strategy
DALLAS, March 21, 2023 (GLOBE NEWSWIRE) -- Rapid Therapeutics Science Laboratories (OTC: RTSL) is optimistic following the OMB’s clearance of FDA guidance on cannabis clinical research. This guidance may pave the way for how cannabis-derived products are regulated. CEO Donal Schmidt expressed enthusiasm regarding the potential for CBD products to be recognized as drugs, anticipating IND submission for their CBD Metered Dose Inhaler by Q3 2023. The company's annual 10K filing is on schedule, and they are working on a re-IPO with Nasdaq. Additionally, the corporate website is undergoing a revamp after being hacked. RTSL aims to strengthen its position in the cannabis market.
- OMB clearance of FDA guidance may facilitate regulatory approval for cannabis products.
- CEO expresses optimism about CBD products being classified as drugs.
- Plans to submit IND application for CBD Metered Dose Inhaler by Q3 2023.
- Annual 10K filing is on schedule.
- Company's efforts towards a re-IPO with Nasdaq show strategic growth intentions.
- Website was hacked, causing operational disruptions.
- Pending regulatory approval for the re-IPO may delay market entry.
DALLAS, March 21, 2023 (GLOBE NEWSWIRE) -- Rapid Therapeutics Science Laboratories (OTC: RTSL) ("Rapid Therapeutic'' or the "Company"), a growth-oriented aerosol manufacturing company focused on natural relief innovations through trusted aerosol delivery, feels steadfast in strategic vision and directive following OMB clearance of the FDA’s Final Guidance On Clinical Research For Cannabis.
On January 18th, 2023, The White House Office of Management and Budget completed its review of FDA’s final guidance on clinical research for cannabis and cannabis-derived compounds. This should be the predecessor of the FDA making recommendations for how to regulate cannabis-derived products, including those containing cannabidiol (CBD).
The guidance cleared by OMB on Jan. 13, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” is focused on development of cannabis-based drug products. It also discusses key regulatory concepts for stakeholders who may be less familiar with FDA and its authorities.
“We are extremely encouraged by the recent ruling as it backs up our inclinations that CBD and cannabis-based products are and will be treated as drugs,” said Donal Schmidt CEO of RTSL. “Our efforts to continue our sustainability and particle size research will put us in a strong position to submit for IND approval to the FDA. From there, we are anticipating we can begin human trials at a major teaching medical school we are in discussions with on our CBD Metered Dose Inhaler no later than the 3rd quarter.”
Schmidt also stated, “We will be filing our annual 10K on time. Our last S-1 has been updated and is ready to immediately refile after the 10K posts on Edgar. Further, we are still waiting regulatory approval for our long-planned re-IPO with Nasdaq. The timing on this is outside our control and like all other shareholders the Company is just trying to be patient. I am hopeful we will be ready to uplift to Nasdaq this summer. In the meantime, I continue to personally loan the company short-term working capital to continue basic operations.”
Please visit our soon-to-be re-vamped corporate website at www.rtslco.com. Please note our website was hacked in December as part of the GoDaddy issues they recently revealed to the public in February. As such, our website, which was infected with malware, has been down for a couple of months. The website is being completely redone because of this issue and we are hopeful to have it functioning properly in the next 60-90 days. The malware did not affect our emails or internal servers which are well protected by professional IT technicians.
About Rapid Therapeutic Science Laboratories, Inc. (OTC Pink: RTSL)
RTSL is a biopharmaceutical company that is focused on natural relief innovations through trusted delivery. As a part of its applied aerosol technology with biologics, RTSL has developed a new method of formulating and manufacturing pressurized metered dose inhalers (pMDI) that contain and properly aerosolize proprietary formula of one or more patent pending pharmaceutical grade cannabinoid compounds. RTSL is committed to continued pharmaceutical research and development on biologics and using its applied aerosol technology. The company is preparing to file an investigational new drug application (IND) with the FDA for its CBD MDI.
Although legal for consumption in many states, CBD is not yet approved by the FDA for human or animal consumption except as a drug in prescription medication.
We encourage all individuals to do their own research regarding cannabinoids, the use of MDI and our other products. Always consult a physician prior to using any cannabinoid product. RTSL makes no therapeutic claims regarding its products, the use of its products, or any results which can be obtained from using its products. None of our products are intended to diagnose, treat, cure, or prevent any disease. If you experience any adverse reaction of any non-psychotropic cannabinoid, stop use immediately and seek appropriate medical attention. RTSL’s products are not approved by the FDA or under the Food Drug & Cosmetics Act (FD&C Act). Our products contain zero THC.
Visit our corporate website at www.rtslco.com. Please note our website was hacked as part of the GoDaddy issues recently revealed to the public. Our website is being redone as a result of this issue and we are hopeful to have it functioning properly in the next 60-90 days.
Forward-Looking Statements
This press release may contain forward-looking statements. In particular, when used in the preceding discussion, the words “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions are intended to identify forward-looking statements. Any statements made in this news release, including statements related to the closing of the offering, other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of RTSL, its divisions and concepts to be materially different than those expressed or implied in such statements. These risk factors and others are included from time to time in filings made by RTSL with the Securities and Exchange Commission, including, but not limited to, in the “Risk Factors” sections in its Form 10-Ks and Form 10-Qs and in its Form 8-Ks, which we have filed, and file from time to time, with the U.S. Securities and Exchange Commission. These reports are available at www.sec.gov.
Other unknown or unpredictable factors also could have material adverse effects on RTSL’s future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements which include, among others, statements related to the closing of the offering, the timing of the filing of patent applications, the failure to obtain patents for our products and processes, the costs associated therewith, a delay in, or the failure of, our filing of the planned IND, or the failure of the FDA to approve the IND, the outcome of studies, the planned timing of product availability, the demand for such products, and our ability to produce significant quantities of such products.
The forward-looking statements included in this press release are made only as of the date hereof. RTSL cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. We undertake no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
Investors:
info@rtslco.com
Media:
Jules Abraham
CORE IR
julesa@coreir.com
917-885-7378
FAQ
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