A hard wait but we know what comes to those who wait!26 Jan 2024 12:19
The FDA will not wait the 30 days to tell us if the CH remains in place is my understanding from reading about complete (CR) responses to CH's, as this is the first thing the FDA need to determine and they would have discussed this by emails or on the phone by now. They initially determine the question, has it dealt with all aspects of the reason for the CH (Are there any elements missing from the required resubmission?). Since we only had one issue and a plan to address the CH which was accepted by the FDA, we would have known by now if it was not a CR at the very least. The next step for the FDA is to get the resubmission reviewed to assess the quality of that response . Once again, this should not take too long because Hemo and FDA both knew what the answer should be to clear CH.
However, the days for a response, although diminishing, in this case, no news is not bad news. I think, for the reasons above, if there was a problem with the response we would know of it by now. However, as well as this, the FDA have to carry out their own due diligence and sign off, so getting people around a table to do that can be a time drag as many of us might know ourselves.
In summary, whilst I would have loved the CH lift dates from the early date guessers to be right, it is absolutely no indicator of the ability of this resubmission to get through. It's a hard wait all the same GLA