RE: News17 Jan 2022 14:06
The potential for Parsortix is huge.
Whilst in the first instance it will not be used for diagnostic benefit, one can imagine scenarios in which it can give compelling evidence in hard to treat scenarios such as pancreatic cancers where surgeons are unable to take even a biopsy let alone remove tumours. In such cases the need for monitoring of treatments is essential.
So a possible diagnostic and most certainly a monitoring tool. I actually do understand why FDA are not just waving this through. However one has to ask, why take so long? Can approval not be given with strong conditions until both FDA, clinicians and scientists learn how to use Parsortix properly.
If you look at Polarean, it was only possible for them to apply a few years back. Maybe FDA need to be flexible without fear. Indeed they could be flexible and make an exception for a tool like Parsortix that has such wide reaching potential.
Thing is of course, regulatory body’s will be regulatory body’s…