The World in Brief This e-newsletter is provided courtesy of Reed CNY Business Law, P.C.
COVID19 – FDA Priorities Works during COVID-19 Due to COVID-19 pandemic, US FDA’s workload has been increased and become more complicated. FDA’s Center for Biological Evaluation and Research (“CBER”) and Center for Drug Evaluation and Research (“CDER”) try to meet their standard 30 day initial investigational new drug (“IND”) review cycle. However, as the FDA prioritizes the review of treatments and drugs for COVID-19, other reviews are officially postponed at this moment. Good news is that FDA staffers are very communicative and working days, nights and weekends to meet deadlines. In these circumstance, communication with the FDA is crucial and the most effective way to work with the FDA. Reed Business Law is confident that it can communicate with FDA staffs efficiently so that our clients would have best consulting service.
코비드 19 팬데믹의 영향으로 미국 FDA 의 업무는 보다 복잡하고 가중되고 있습니다. FDA 내 연구기관들은 신약검사에 대해 30 일의 기존방침을 고수하고 있지만, 코비드 19 의 치료제에 대한 검사를 우선순위에 두고 나머지 검사들은 지연시키는 결정을 내렸습니다. 이러한 상황에서는 FDA 직원들과의 지속적인 커뮤니케이션이 무엇보다 중요합니다. 저희 로펌은 FDA 직원들과의 효율적인 소통을 통해 클라이언트에게 적절한 서비스를 제공하고있습니다.
Bio-Pharma – FDA Slams Bristol Myers with a Surprise ‘Refusal to File’ Letter Bristol Myers Squibb grabbed drug candidate ‘ide-cel’ as part of its acquisition of Celgene. The drug was developed by ‘bluebird,’ a company with little experience dealing with the FDA. This may explain why the FDA issued Bristol a rarely used “Refusal to File” (RTF) letter, blocking the drug’s application. It is all the more shocking since the FDA and the industry it regulates agree on one thing – RTFs should be avoided at all costs. Traditionally, companies will ‘pull’ their applications at the first hint from the FDA that an RTF may be issued, allowing the company to explain to stakeholders it took actions ‘voluntarily’ rather than by order of the FDA. Maybe Bristol decided too much work had been done prior to its acquisition to withdraw the application. Or maybe Bristol was too focused on getting an FDA approval by March 2021, which would increase payouts to shareholder under the ‘CVR’ terms of its Celgene deal. But, no matter how many meetings had been held with the FDA prior to Bristol’s involvement, and no matter what value a successful application would bring to shareholders, Bristol is now left having to convince investors, the market and patients that the drug will someday be available for sale. If Bristol, a successful US-based company, can misread the FDA’s signals, the lesson is crystal clear: first-time, foreign applicants should make sure they have advisors (like the team at Reed Business Law) experienced in translating FDA ‘signals’ for non-native English speakers.
Bristol Myer Squibb (BMS)은 Celgene 과의 합병을 통해 ide-cel 이라는 신약후보물질을 취득하게 되었습니다. Ide-cel 은 FDA 와의 소통이 거의 없던 회사인 blue bird 라는 회사가 개발한 치료제입니다. BMS 는 FDA 로부터 ide-cel 에 대하여 신약검사신청을 거부한다는 RTF 메일을 받게 되었는데, 그 이유는 소통이 부족했다는 것이 미국 바이오시장의 평가입니다. 저희 로펌은 한국 클라이언트들의 FDA 신약개발신청에서부터 임상실험검사 및 RTF 메일, import 66-40, 66-42 등의 커뮤니케이션 이슈에 대해 컨설팅해드리고 있습니다.
CRYPTOCURRENCY – US OCC Proposals for National Licensing of Crypto (Like Banks)
A chief operating officer of US Office of the Comptroller of the Currency (“OCC”), the nation’s bank overseer, stated crypto companies could fall under a federal licensing regime. This is positive news for startups and venture capitalists, because crypto companies could become licensed at the federal level rather than at the state-by-state level. Even though it’s only one officer’s proposal, it could be a meaningful signal, as there is much uncertainty for crypto companies, yet. Reed Business Law provides global consulting service for clients who wish to have expertise in blockchain technology.
미국연방 통화감독국의 chief operating officer 가 암호화폐를 발행하거나 운용하는 회사들이 연방 차원에서 관리를 받을 수 있을거라고 발언했습니다. 본 발언은 스타트업이나 벤쳐캐피탈들에게는 고무적인 소식으로 해당회사들이 주마다 다른 제도를 통해 라이센스를 발급받을 필요없이 미연방관리국의 허가를 통해 비지니스를 하게 될 수 있습니다. 저희 로펌은 블록체인 기술을 통한 암호화폐를 발행 또는 운영하는 스타트업들에게 컨설팅해주고 있습니다.