Just wanted to update my earlier observation. When I checked the record on 05/27 earlier in the day it did not have a dual categorization under the "Expanded Access Type" field. The full clinical record can be found at the Clinical Trials website -> https://clinicaltrials.gov/ct2/show/NCT04338347?term=Capricor&draw=1&rank=5. I looked it over multiple times, took notes, etc. and the label was "Intermediate-size Population" - I have that written down in my notes. I strongly feel (but I cannot prove this since I did not save a screenshot) that the record was updated sometime later to include the "Treatment/IND Protocol" label which is typically reserved for commercial access with a confirmatory trial - like what was done for Remdesivir recently. Of course, its possible this is a mistake in the clinicaltrials website, but that is not normal - and doesn't explain why the widespread label did not exist earlier.
There's definitely a possibility that something like a widespread access is in the works, but we won't get a confirmation until its either posted in the fda.gov website or on Capricor's website. If something of this nature has been communicated to Capricor, typically, the clock for issuing a PR is 72 hours so by Wednesday 06/03, we should know know for sure.
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