RE:is it too much to ask forYou don't seem to be on page on what they say and so far, they are respecting what they said:
Dr. Mandel says that the company plans to apply for FDA breakthrough drug designation in the first quarter of 2023 on the basis of the Phase 2 clinical study data collected to date.
So last time I checked, Q1 ends March 31. Then add 60 days for the FDA.
There maybe many reasons why they're vague regarding the moment. Maybe they're waiting for a prerequisite. Could be trying to wait for more 450-days milestones that would help increase our efficacy %s, could be to make sure shorts are kept on their heels, etc ...
So we wait. No company announce when they apply as this is not material. But they will have to News release the FDA decision.