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Monday, March 20, 2023 7:43:48 PM
Later today this came out:
https://newsytrends.com/2023/03/20/revive-therapeutics-ltd-cse-rvv-otcmkts-rvvtf-reverses-off-52-week-lows-as-fda-adjusts-endpoints-in-bucillamine-trials-more-on-rvv-psilocybin-clinical-study/
Revive Therapeutics Ltd (OTCMKTS: RVVTF) is a biotech sleeper that hit new 52 week lows on Monday after the FDA adjusted the endpoints of its Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19. The Company is still committed to advancing the clinical and commercial development of Bucillamine and decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. Revive has a lot going on besides this; the Company was granted orphan drug designation for cannabidiol in the treatment of autoimmune hepatitis by the FDA and has entered into a clinical trial agreement with The Trustees of Indiana University to develop and manage a clinical study entitled, “Use of Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis.”
Revive Therapeutics made a legendary run up the charts during 2020 culminating in a run to over $0.70 per share in the US. Now the stock has reversed off $0.0296 lows in the US after over reacting on the Bucillamine update.
Revive has a lot going on; the Company is evaluating psilocybin in a Phase 1/2 clinical study for methamphetamine use disorder via a research collaboration with the University of Wisconsin-Madison, developing a novel psilocybin oral thin film strip through a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films as well as developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University. We will be updating on Revive Therapeutics when more details emerge ...
Revice hit new lows on Monday after the Company announced an update from the FDA Phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties in patients with mild to moderate COVID-19. On March 8th, 2023, the Company received the Type C meeting written responses from the FDA to obtain agreement on the proposed protocol endpoints for the Company’s Study. The FDA recommended that the Company’s proposed primary symptom-based endpoint should cover the evaluation of time to sustained recovery assessed over an appropriate duration, evidence of subjects experiencing resolution of COVID-19 related symptoms and the element of sustained symptom resolution.
After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As a result, the Company is committed to advancing the clinical and commercial development of Bucillamine and plans to pursue the following activities:
Continue discussions with the FDA on a pathway for future potential regulatory approval under the current Study’s objectives, which the FDA and DSMB continue to support;
Work with the Study’s current participating clinical sites and potential new clinical sites to develop a defined recruitment plan that prioritizes subjects recognized to be at higher risk for developing severe COVID-19 to achieve the Study’s objectives;
Determine potential opportunities of unblinding additional data related to the Study for evaluation to support future discussions with the FDA, and further studies for Long COVID or COVID symptom-related conditions, which the FDA provided advice to pursue, and various infectious and respiratory disorders;
Develop reformulation strategies of Bucillamine to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug (i.e. ischemia-reperfusion injury, cystinuria), fast track, and breakthrough therapy designations; and
Secure alliances with strategic partners, including pharmaceutical companies, to achieve Bucillamine’s full commercial potential.
"Currently trading at a $22 million market valuation Revive Therapeutics os is 320,008,751 with 315,580,417 shares in the public float. "
Bullish head and shoulders 3 year pattern is a buy. And there is 100% rally gap over head to cover from the morning low.
![Bullish](/static/images/ih2-bull.png)
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