Madonion I consider myself a realist before a skeptic
You're right, the FDA's current PMA approval timeline is a minimum of 1 year. But PMA is a long way off for OncoSil yet. First the IDE has to be approved. Then ethics approvals and recruitment of ??? patients secured. And then - IF the IDE results obtained conclusively demonstrate safety and efficacy - the trial data can be fed into a PMA application.
Re: delay versus disapproval ... the only regulatory mechanism that affords a company an opportunity to provide an additional 1700 pages of information post IDE submission is a disapproval with deficiencies identified. That's simply FDA regulatory process.
Madonion I consider myself a realist before a skeptic :) You're...
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