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Saturday, November 06, 2021 12:43:43 PM
So, if they can get world experts to be amazed, despite some trial follies, perhaps the "new" FDA can be more friendly. Which, takes time to execute this kind of plan, hence, a long cold winter wait....uhg again.
My confidence wains some as I take off my rose-colored glasses.
We KNOW 100% DCVAX works !!! Yes we do, but, from a trial perspective, AF might be right and we have an unapprovable trial, for the FDA. MHRA on the other hand, ??? Who knows.
reposted due to some typo's that changed some meanings.
add-on, hoping "into the market" is via NICE...as a BLA would still take 1 year, or more after TLD. IMHO
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