I am not pleased with his answer regarding breakthrough designation. On the last call, he said that after the August meeting he had asked to immediately apply for breakthrough designation. Now, he says, they were advised not to apply (when was that btw?), because they are so close to approval, but simply ask FDA to defer stability data.

Alright - but what if FDA declines? There is nothing in the FDA guidelines that precludes them from applying for breakthrough designation even at this late stage and the formal status "breakthrough" would bring more visibility to the company and once again confirm the science.