They had to have the proof of concept done in order to go to the FDA to determine what else will be required in order to submit a PMA or NDA so that they can begin a clinical trial. Once they have that direction from the FDA, which may require another round of animal studies, the total cost for all four trials (vitiligo, traumatic wounds, gene therapy and regeneration) will likely run between 70-90 million over the next 5 years. With 110 million in cash or equivalents they should be OK for the next couple of years at least.
Ann: AVITA Medical Establishes Proof of Concept for Gene Therapy, page-12
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