Shots:

• The company initiates P-II KET-LID clinical trial to evaluate the safety- efficacy- and PK of Ketamine (sub-anesthetic- IV) vs PBO in patients with LID associated with PD. The patient enrollment is expected to initiate in Oct’21 with an anticipated PDUFA date on Q4’21
• The 1EPs & 2EPs are the changes in the total score & objective score (III- IV) of UDysRS- total daily OFF times as assessed by patients completed 24hrs. diaries along with a total score of UPDRS part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV
• The company plans to discuss with the US FDA to initiate a P-III clinical study under the 505(b)2 regulatory pathway in H1’22- based on the P-II results

  | Ref: Globe Newswire | Image: Globe Newswire