"... FDA approval is not 100% guaranteed, and it would be quite arrogant to just assume it will be."
Right. Has anyone said that it is totally guaranteed?
I don't think so.
However, to leave that as a bald statement is to deny contextually what is already in place. It is effectively saying that no assessment can be made about the relative likelihood of success based on what has already occurred.
The technology has been clinically proven and accepted elsewhere and early clinical trials in the US so far returned with significantly high rates of both wound recovery and pain reduction in burns patients.
The fact that US Defense has backed AVH with financial support suggests a serious degree of confidence in the product.
Even though FDA approval is not a certainty, in relative terms, given the above and other relevant information posted elsewhere, it would appear that technical rather than fundamental issues would be obstacles to the path of approval. If this is the case, they are more likely to be involve adjustments involving delay rather than total failure.
To deny the relevance of these factors in making a determination about likelihood of success in FDA approvals is a potential risk in itself.
I leave aside the issue of arrogance. This is a discussion board and that was remark IMO is inappropriate.
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