Well, let's get back to the basics
IMO it's not unreasonable for FDA to ask questions, but the key to whether FDA will reject it lies with:
1) Is it safe
2) Is there potential to show efficacy
Admittedly clinical data available to date are from small trials - not dissimilar to SRX.
1) In the limited dataset, the device appeared to be safe
2) The studies also showed potential for efficacy, one of the studies showed OS ~10mths vs ~5
The mechanism of action is simple, if there is a hiccup with approval it's probably due to paper work rather than the device not working. Note that I'm not ruling out the potential for a hiccup hence my hold sentiment
Well, let's get back to the basics IMO it's not unreasonable for...
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