Mesoblast (MESO) said late Wednesday it expets to have a type B meeting with the US Food and Drug Administration during the current quarter to discuss the accelerated approval pathway for ischemic heart failure treatment candidate, Revascor.
The main goals of the meeting are to get FDA feedback on relevant chemistry, manufacturing & controls, alignment on potency assays for commercial product release, and the company's proposed design and primary endpoint for the confirmatory trial, it said.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.
Comments