I don't think we will hear anything for 1 month. It's up to the FDA to decide if they want to accept Ampion as a break-through drug, If they decide not to approve the BLA the company will have to start their final trial which should take 3-4 months
Grindle - This was nwever a BLA meeting. It was a pre-BLA meeting. The breakthrough application needs to be made after the next study. Woudl think this one will be done internationally and thus get approval in Europe, Australia and N. america w/o any more studies.
According to the FDA website, the minutes of the meeting will be sent out no later than 30 days.
I'll admit to have been too hopeful for an immediate decision, but the reality is that this is typical bureaucratic pace. Still, some type of fast-track or accelerated development decision seems warranted assuming the FDA considers OA as a "serious" disease with no good alternative drug.
Time to quit looking at the account daily...though last week was fun.
You are spot on regarding the FDA and if we hear in a month, consider it lucky. Even if they do not accept as a break-through, a 4 month trial is virtually nothing in regards to timelines in the bioworld. This puppy is a keeper, trading this could be dangerous as when an announcement comes out, it is going to move so rapidly it will be very difficult to chase...
I thought in your analysis a while back, regarding three possible outcomes they were going to make that decision on status on this date? If not, do you know when they are expecting that announcement? Thanks