what's the problem? you think having 2 failed FDA registrations followed by 2 unsuccessful dispute process is not a problem?
You know the issues faced by MSB proving to fhe FDA that RemL works and works consistently. That MSB made an original application using failed trial data, third party data and a questioned null hypothesis for the P3 obviously is a problem as well as stated by the FDA.
The covenant headroom on MSCs must be getting a little claustrophobic right now. But what's that matter when you are
over AUD1B in retained losses, your Crown Jewels are security for loans and your other clinical assets are regression analysis blockbusters?
But hey - ReML is important for those sick kids yeah? Nothing to do with proving a point with the FDA?
Cell Therapy News/Articles, page-17069
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