Sure, they can & I’m sure will be ‘encouraged’. I hope it works.
However, as I see it, until such time as the FDA actually spit out Minutes of meeting that the company can feel do support Accelerated Approval, the company must push forward hard with the best prospect for Rexlemestrocel on the table.
Right now that’s CHF (HFrEF) with LVAD as I see it.
We all recall, I’m sure, we have been burnt expecting an approval from the FDA previously.
In reality, I think the pressure on everybody at Mesoblast to work even harder has just increased. Because nothings guaranteed. Absolutely nothing.
Biotech.
Cheers
2024 Here we go again., page-255
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92.5¢ |
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