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.
OSL Price at posting:
14.5¢ Sentiment: None Disclosure: Not Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)