SMD P2B Pivotal a Slam Dunk Indeed! There is only 1 way IMO that the EMA is promoting this trial. They have obviously seen the clinical results in confidence for the Cohort2A 100K RPEs P1/2A 20/100 VA for the 8 SMD and 4 AMD patients. These safety/tolerability/efficacy results have not yet been made public and IMO a Peer Review paper is being prepared to be presented in 2015.
With 3 to 4 years of actual history, the results for these 12 patients are prompting the EMA to act now and immediately. $OCAT will get all the help they need from the EMA to move forward quickly with the new P2B 100 patients SMD that have 20/100 VA. While 100k RPEs were injected for Cohort2A in P1/2A, the safety of 200K has also been proven for the 20/400 Cohort. IMO 200K to 400K RPEs injection will also be trialed in the P2B.
SMD Orphan Drug Commercialization by mid-2016 a reality indeed IMO. It is the EMA's call based on the expected successful results for the Pivotal P2B.
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