Replies to post #37139 on Vivos Inc (RDGL)

[Chief Slapaho]

That's really a stretch and I don't buy it. AMIC's technology is cutting edge and the FDA likely didn't have the acumen or expertise on staff to evaluate it properly without bringing in consultant expertise. I believe quite the opposite ... they want to get it right before approval. Besides, there are already 2 somewhat similar devices on the market that have been approved.

[show_me_money]

I think the FDA would always consult with a "specialist". They have to get it right.

Well right for right now. They definitely don't always get it right.

[DankTrader]

If something is good you don't worry about a specialist.

IMO, This is the exact reason for the FDA agency. If they 'didnt need a specialist' for every drug that comes across their table, there would be tons of lawsuits everyday and it'll come back to them for allowing such a drug to be sold to the open market or used by medical doctors and such. However, if it's a newer cutting edge technology and/or drug that's not widely used, extra measures should be taken to ensure they've got their bases covered all over the field. That could be the reason for the appointment. Keep in mind the actual drug has been approved and this is to cover the device sued to administer the drug.

All imo tho..GLTA

[nathanial]

slef....that's a good point.