KOO - This is where he refers to the response letter.

"upon written confirmation from the FDA" 

Different wording has been used at various times all referring to this. The use of the term, "letter" goes all the way back to the last AGM. DM then referred to another company emerging from their meeting with the FDA feeling everything had gone great and they made announcement to that effect and proceeded accordingly. DM said that their letter then showed up and it was not nearly so rosy and they had a lot of egg (my term) on their face. DM showed yesterday that he wasn't about to make that mistake and will wait for the letter before he speaks of the results of the meeting past his basic statement that it went well.