Ann: Type D Response Submitted and Received by the US FDA, page-17

They had the meeting in January. They were speculating they would do what they have just done in first 1/4 - it's now early second 1/4. They won't have any great influence on how long the FDA take to come back but the FDA granted them fast track already.
PAR mention they spent more previously but that would help them facilitate the next stage. The quarterly will be interesting on the spend side and cash balance. Perhaps if the 2mg is approved a deal may be more negotiable and succeed?
I'd say buying now at these levels is a good punt-wish I had waited. Less as possible diluted funding will be important. Correct, the science and results and years in the animal industry haven't changed. Sentiment and value certainly has!!
While they're waiting, they can fix up the governance side of things.