RE: SP drop20 Apr 2021 07:56
During their presentation two weeks ago Polarean said they were already actively engaged in dialogue with the FDA, who had sought some clarifications, which had all been answered satisfactorily. I was surprised that this dialogue was going on so early. The fact that this is a medical device, and not a drug, suggests to me that there will be no delay to FDA approval. If anything it sounds like the FDA are well ahead of the game. This will not wait until Aug/Sept for the re-rate, it will start imminently