nasdaq,cvac and fda

i am positive that short termers are sweating on nasdaq listing to make a quickquid
i sincerely hope they do
as a long termer if the nasdaq announcement[presuming it happens] does occur i believe there will be a flurry of activity and who knows where it will end up
from what what i can gather after the nasdaq listing if nothing of substance happens we will be asking ourselves what was the big deal about the listing because any spike that occurs will quickly disappear
so as a long termer the nasdaq listing does not really matter to me but i am more interested in positive trial results and consequently fda approval
i have no medical knowledge but cvac is some sort of treatment that involves taking blood from a sufferer.doing something to it in a laboratory then administered back to them to make their life a bit more longer and comfortable
my question is
is cvac classified as a drug as per aspirin for example
my next question
presuming cvac is shown to work will fda approval be subject to the same scrutiny as a new drug that is available from a chemist to anyone that can get a doctors subscription
by this i mean a sufferers blood when treated with whatever cvac is is only ever given to the donor and nonone else so can there be any risk of class action etc if something goes wrong
so is there aliklehood of cvac being approved and thus put into production quicker than normal drug approvals
commonsense says yes