If the company wanted to maximise shareholder value, the only benefit in these FDA advances, and they are advances, is to leverage them into a US partnership deal.
The company can hang onto Europe and Australia.
But it MUST partner US and Asia.
It cannot manage those approval processes in those markets on its own. A partnership deal will see the share price rise, as it will give real credibility to the technology and remove the stigma around the current management's skills in regulatory approvals.
News: OSL Oncosil Medical Files For Registration Of Oncosiltm Device In U.S. Market, page-7
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