If you read the HUD guideline it says they will respond and in that response it could be YES NO or Need more info. So saying Today is the last day or tomorrow is not true. This HUD submission is not the same as getting Human Trial approval. I personally am on board for the long run and the HydroGel anything from the device is a bonus to me.
Hi a1ag. I believe while you are correct on there being 3 choices, the more likely would either be a yes or a "need more info" and not a flat no. My reasoning on this has been illustrated on this board: In their meeting with the FDA, it was *agreed* that this would be the pathway to pursue. Any disqualifying "no's" would have prevented this "agreement in principle" from the outset. So, it should either be a yes or be a " look guys we want to say yes but we need a little more info." I hope it isn't the later because another delay would be painful. I am really hoping it will be a straight "yes" because that should also kick the IDE request some juice. That being another critical item that is expected fairly soon.
Also, if you go back to Jsteve's original post about the FDA news release, I found what he was talking about and shared how to find it. Not sure why he didn't give people details on how to find it. Some people and their high horse....
If you read my comment carefully, you would have noted that I stated the FDA made an announcement related to HUD. Nothing more. You see to be very sensitive to comments or not very astute. I am providing information with a purpose but you seem to be very judgmental and I will suggest that you act out of some level of ignorance or arrogance. Try to be more careful and maybe others would not be quick to conclude the type of person that you may be. Cheers!