I misunderstood what was sent to the FDA. I application sent in today is only for ODD which is not the IND. I initially believed that the company sent the IND which included the ODD. A more careful reading of the PR states only the ODD paperwork was submitted. It is my understanding that the company will have to submit the IND for RP at a later date once it gets the ODD designation for MANF/RP. My apologies. Even "experts" can get it wrong just like the CDC head did with Ebola. I am trying to get clarification from Gerald.
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