Nope, but I suspect they have been working on the application these last months and this data is what we were waiting for. It should be very advanced.

CytoDyn plans to update its Breakthrough Therapy designation application and file for BTD for mTNBC

The data is world-class for mTNBC as far as survival improvements. Also, we should be able to design a trial with an extremely high success probability readily knowing which patients respond and which ones don't.