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Thursday, March 30, 2017 9:07:54 AM
I know it gets lost in all the optimism here, but nobody actually knows. I even emailed the FDA for the hell of it and of course I got the response that it is not public record.
What we do know is this: US Stem Cell was one of many who lobbied in front of congress to bring about this new regenerative medicine designation. So logic tells you that they likely didn't wait months to apply for the designation. Why would they?
Many here, including myself, believe that they applied during the first couple weeks the FDA began accepting these applications. Some have speculated that because the clinical trial .gov site was updated the end of January that it confirms this. Could be a coincidence but who knows. Personally I believe news could come any day within the next couple weeks. Maybe tomorrow after AH. But that's my opinion.
Worst case scenario, they didn't apply until march 13, when the CEO announced it via his blog. Why would they wait that long? Maybe to get their ducks in a row. Dot their i's and cross their t's to minimize any setbacks. They wanted to make sure their application was perfect. Again, I doubt they would've waited, but this scenario would have us waiting until first couple weeks of may.
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