NRx Pharma's COVID-19 Candidate Receives FDA Review For Manufacturing Information
NRx Pharma's COVID-19 Candidate Receives FDA Review For Manufacturing Information
NRX制药公司的新冠肺炎候选人收到美国食品和药物管理局关于制造信息的审查
- NRx Pharmaceuticals Inc (NASDAQ:NRXP) has received the FDA's response to NRx's submission of updated manufacturing information for Zyesami (aviptadil).
- The completion of this review, without the imposition of any clinical hold by the FDA, enables NRx to distribute Zyesami for clinical trials and other future purposes approved in future regulatory actions.
- NRx looks forward to working with the FDA to complete the chemistry, manufacturing, and controls (CMC) review.
- Zyesami was manufactured for trials purposes in 300 dose batches, with a limited shelf life of 62 days.
- The FDA has now reviewed a GMP manufacturing process at a batch size of 10,000 – 100,000 doses with a current shelf life of 150 days and identified no basis for a clinical hold.
- Related Link: NRx Pharma Stock Nosedives As FDA Strikes Off Its COVID-19 Drug Hopeful.
- Price Action: NRXP shares are up 5.36% at $6.39 during the market session on the last check Thursday.
- NRX制药公司纳斯达克(Sequoia Capital：NRXP)已收到食品和药物管理局对NRX提交的Zyesami(Aviptadil)最新生产信息的回应。
- 这项审查完成后，FDA不会强制实施任何临床搁置，使NRX能够分发Zyesami用于临床试验和未来监管行动中批准的其他未来用途。
- NRX期待与FDA合作完成化学、制造和控制(CMC)审查。
- Zyesami是为试验目的生产的，分300剂批次，有限的保质期为62天。
- FDA现在已经审查了GMP的生产工艺，批量为10,000-100,000剂，目前的保质期为150天，没有确定临床搁置的基础。
- 相关链接： NRX制药公司股价暴跌，美国食品和药物管理局取消了其新冠肺炎药物的希望.
- 价格行动：在周四最后一次检查的市场时段，恩智浦股价上涨5.36%，至6.39美元。