The FDA response to the request for the ODD and Rare Ped Disease Designation should be coming soon- it could really come any day now- it's been over 4 months. The last ODD they received took a little less than 4 months to get from the FDA. It will be very interesting to see how the market reacts if it is approved. I don't think this company has had any substantive good news in a year.

One theory is if they do end up spinning off ESS in some way, there is probably a good possibility that the RPDD would be included so maybe they are waiting for FDA's response?