FDA approval is a regulatory gauntlet that includes at least...

FDA approval is a regulatory gauntlet that includes at least three phases of clinical testing for safety and effectiveness, each more exacting than the one before.
Then it goes through a final review by the FDA and may include prescreening by one of 33 advisory committees, as well as a final assessment by the FDA Center for Evaluation and Research (CDER).

What is VitroGro - seen from FDA's point of View: Drug? (Unlikely) a Medical Device? (Unlikely) Vaccines, Blood and Tissue Products and Biotechnology (Most likely) ....

Statistics re DRUGS: The odds aren't good. New drugs take an average of eight years to get through the clinical trial process, and only one in five survives to the finish line.
Statistics re Vaccines, Blood and Tissue Products, Biologicals: Don't know and couldn't find anything

Whether or not VG has to go through the full FDA process cycle or not I do not know and TIS management has not disclosed the path through it (i.e., whether or not a BLA [Biologics License Application] is required or has already been done).
But what I do know is that TIS management has a track record of underestimating regulatory approvals and is always coming up with overly enthusiastic timeframes.

Any comments?