Approval as late as the Spring of 2025 is completely unrealistic.
1. The 150 fast track started with the MAA submission on 12/20/23 and Spring 2025 would consume at least an additional 10 months. Even before 2024, MHRA decisions were not rendered more than a year from submission. 2. I am guessing that of the 86 trial sites perhaps 10-20 (a representative sample)) were inspected so as to make sure that the trial records represented the required procedures. I am quite certain that most of those sites have already been inspected and that the remaining inspections will be conducted within the next few weeks because I very much doubt that in the absence of approval by sometime in early June, the ASM would have been scheduled for no later than late June.