ReikoBlack
3 weeks ago
Revive Therapeutics Provides Update on Research Study Evaluating Bucillamine for Nerve Agent Exposure
July 02, 2024 13:58 ET
TORONTO, July 02, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today an update on the research study evaluating Bucillamine as a potential treatment for nerve agent exposure, in partnership with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence. The DRDC is investigating pharmacological compounds, including Bucillamine, that can mitigate nerve agent induced brain injury. Control studies have been initiated and the DRDC expects to evaluate the data this month. Treatment studies will follow after the conclusion of the control group evaluation. The research study is expected to be completed in August 2024.
Nerve agents are chemicals that affect the nervous system. Nerve agents are highly toxic regardless of the route of exposure. The main chemical nerve agents that are man-made and manufactured for use in chemical warfare are sarin, soman, tabun and VX. These nerve agents are known to be present in military stockpiles. Exposure to nerve agents can occur due to chemical warfare or accidental release from a military storage facility. Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death.
Recent studies have shown that antioxidant compounds such as n-acetylcysteine (“NAC”) could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam.
Bucillamine is a significantly more effective antioxidant than NAC and has the potential to provide increased efficacy against seizure activity while limiting the anticoagulant and bleeding event liability observed with NAC. The overall objective of the research project is to investigate pharmacological means for neuroprotection of GABA(A) receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA(A) receptor endocytosis and the effect on diazepam effectiveness in terminating seizures. Any additional antioxidant effects on seizure activity and survival will also be assessed.
The results from this research study, if promising, will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning. Also, the Company may explore the potential of Bucillamine for traumatic brain injury caused by concussive or explosive forces.
https://www.globenewswire.com/news-release/2024/07/02/2907735/0/en/Revive-Therapeutics-Provides-Update-on-Research-Study-Evaluating-Bucillamine-for-Nerve-Agent-Exposure.html
Classic Warrior
1 month ago
Yea. It looks like MF is going to trial to make Bucy the long covid wonder drug. Based on the volume after these press releases, nobody cares. I've put my work boots on and in another year I will have made my money back from work. For now, I hold my shares and check once or twice a day. My back up plan is to have that reddit guy come back and make a gamestop run and get my money back. I've accepted the loss, but as a gambler, I still have hope.
ps. I always thought the vegas trip was a great idea, but I now see that will likely never transpire. We had our chips in at the right time, but kept getting sucked out.
pps. It's hard to wish people luck anymore because we are so beaten down and many have understandably moved on, but there is always a chance. I'm just not investing anymore here at this point That's my two sense. Boy, we haven't seen that for a few weeks. Those are just my honest thoughts at this time.
Giovanni
1 month ago
The Benefits of Pursuing the De Novo Pathway
The De Novo pathway, introduced by the FDA in 1997, allows companies to receive FDA clearance for low or medium risk medical devices with no existing predicate, or no substantial equivalence. This submission option presents manufacturers with lower fees when compared to a PMA ($132,464 vs. $441,547), as well as a faster review period (150 days vs. 180 days). The device must still meet FDA standards for safety, effectiveness, and good manufacturing practices for successful clearance, but developers will often find that the De Novo process offers a less burdensome route to FDA approval. Some companies also feel there is a marketing benefit to launching a novel device with a classification that no other device has been given.
The Potential Drawbacks of the De Novo Pathway
The FDA’s De Novo pathway for novel medical devices can be long and costly. In 2023, the fee for an FDA De Novo vs. 510(k) is significant – a De Novo classification request is $132,464, while the fee for a 510(k) is $19,870. In terms of timing for a 510(k) vs. De Novo submission, the difference is also considerable, with De Novo requests having a target review period of 150 days compared to 90 days for 510(k). Furthermore, there is no guarantee that clearance will be granted; rejection risk remains a concern. The FDA may request supplementary clinical or nonclinical data in an Additional Information letter. They may also decline the request if they determine a similar device has already been classified. If the request is granted, the new classification nearly always comes with special controls that will be imposed on the device as well as all future devices using that device as a predicate. Upon granting the classification request, the FDA will publish a notice of the classification order, including any special controls, for use in future premarket notification 510(k) submissions.
The Timeline for the FDA De Novo Process
A thorough understanding of the De Novo review timeline is beneficial so that manufacturers can map out an appropriate submission strategy and be prepared when evaluating feedback. After your submission, the FDA will assess the application for completeness and evaluate if it can meet the burden of reasonable assurance of safety and effectiveness. Depending on FDA input, medical device developers may need to collect additional clinical or nonclinical data and submit additional information beyond the original submission. FDA review times vary but the FDA’s goal is to issue a decision about a De Novo request within 150 days, excluding any days that the request was on hold if an Additional Information request was issued. After adjusting based on FDA feedback, developers can expect final FDA decisions within 250 days from initial submission, but the review process will ultimately vary on a case-by-case basis.
We can help. The FDA De Novo pathway is just one regulatory pathway that medical device companies can take to introduce their product to the US market. Knowing which devices are eligible and understanding the benefits and risks associated with it are critical for deciding whether pursuing the De Novo pathway is right for your device. If you’re unsure about the right regulatory pathway for your medical device or how to patent a medical device, our team of regulatory compliance consultants can help you understand which regulatory strategy will be best for your device. Please contact us today.