On 2nd of October 2020...
“We’re going to have a meeting with the FDA in the next 30 days to discuss an accelerated approval, which is a conditional pathway, and we will agree to do another trial but after the product gets approved,” Mesoblast CEO Silviu Itescu told BioWorld.
So has the Type A Meeting request been submitted?
Also, a bit of loose reporting...
“The body of evidence around the use remestemcel-L in inflammatory conditions continues to build,” Itescu said. The stem cell therapy currently has emergency use authorization in the U.S. and Australia to treat ARDS due to COVID-19.
EUA has not been given!!!
We are still I'm a trial phase
MSB Trading 2020 - a new dawn, page-8829
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