Phase2A vs Phase2B
In FDA Clinical Trial studies it is important for all shareholders to understand that there are 3 study types for the FDA to review initially. Namely:
(1)Phase1 for safety evaluation
(2)Phase2A for tolerability evaluation
(3)Phase2B for efficacy evaluation
It is very unfortunate that $OCAT designations have not properly distinguished between 2A tolerability and 2B efficacy Clinical Trials for complete clarification to all readers. However it is always understood to be the case by the medical science professionals.
$OCAT RPE AMD-USA, SMD-USA, SMD-UK are currently at Phase2A tolerability of Cohort 4 200K RPEs injections. These trials are being evaluated for 9 persons, 3 per study, and when reviewed statistically by the FDA, EMA, and DSMB are expected to be reported on by $OCAT thru official SEC/PR filings and perhaps TLD Peer Review publication.
When the Phase2A Cohort 4 200K tolerability has been completed officially and reported, then this will conclude $OCAT Phase2A tolerability trial evaluations enabling them to proceed onto a Phase2B efficacy Clinical Trial.
Preliminarily $OCAT has indicated in their various publications that their Phase2, meant officially as Phase2B efficacy, will be for 100 persons SMD and 45 persons AMD.
