The IDE OSL have is for a pilot study (drug equivalent is a phase 1 trial). This will not be sufficient to get market approval in the US. OSL will need to submit and gain approval for another IDE for a pivotal trial, then recruit the ~300 patients and demonstrate a statistically and clinically significant advantage over current standard of care (in the US) Advantage over substandard care used in other geographies will not be sufficient to gain a market approval from the FDA.
Having worked in this area, I assure yo u the process will take longer then 2-3 years.
Merry Christmas y’all. 2019
The IDE OSL have is for a pilot study (drug equivalent is a...
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