I assume the TGA will have a similar approval endpoint as the FDA, as @1lluminator advised in post 76936199: "[The] percentage of patients with a complete wound closure."
Cynata didn't have this as a primary endpoint. But yes, as you pointed out there don't appear to have been any safety issues, and the ability to heal large wounds looks particularly impressive, so perhaps this is one of the rare times an EAP could be granted. I would imagine you'd need to have a fair bit of clout to negotiate this with a regulatory agency, hence why partnering this is so important.
CYP Price at posting:
22.5¢ Sentiment: Buy Disclosure: Held
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