Drug development is not supposed to be a gamble— it’s a calculated risk. If you don’t have the goods, the correct action is to figure out what data is necessary, design a proper trial to achieve that data and then execute competently. It is not the EMA or FDAs fault that the available data is not convincing. It was Missling’s responsibility to know what cards he held. No one would fault him if data was less than stellar — that’s biotech. But all should fault him for wasting 2023, 2024 , 2025 and now 2026 when he knew the data was insufficient. He gambled 200 MM of your money (while skimming 10 percent along the way) on a 30 to 1 longshot
of course, there is another possible gamble. Bundle up all they have today and submit it to the FDA.