From what I remember reading the gag time is up to the effective date, which was on the 18th. This might be why we had no news from December till now, I'm not sure of the specifics. I'm calling the FDA tomorrow, I'm curious if the have to immediately release results of anything, good, or bad; I think they do. Upon approval from the FDA, they expect phase I clinical trials to begin in June. The S-1 dilution was in regards to Regen BioPharma and yes you would be correct, he pretty much said it won't happen. We won't need to dilute after FDA approval and/or FDA Orphan status.
I'd honestly worry if it was a drug we we're waiting for approval on, but being a treatment using the patients on cells, I feel pretty positive about them.
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