RE: Early FD A approval7 Nov 2022 17:15
Do you think the extension is partly, if not mainly due to the FDA undertaking their inspection quite late in the day? Based on the RNS on 22/9, below, it refers to a recent inspection, and we know the FDA is quite busy, so potentially this should have occurred a few months earlier. Based on this the FDA appear to be admitting some liability and are giving this every chance of success via regular update meetings etc.
This gives me a level of confidence that we will get a successful outcome.
However, I am still struggling to understand what the issue with the gas manufacturing might be.
the U.S. Food and Drug Administration ("FDA") has requested additional information from Polarean's xenon-129 gas blend drug manufacturing partner. This request is related to the recent cGMP (Current Good Manufacturing Practice) pre-approval inspection at the partner's production facility. The FDA has suggested that the required information would constitute a major amendment to the New Drug Application ("NDA") that, if timely submitted, would allow for the FDA to grant a 90-day extension to the review timeline. The FDA has proposed frequent meetings to occur during the extended review period to ensure that any questions that arise during the review can be rapidly addressed to provide the best chance at a positive review decision by the extended date.