a lawsuit based on what exactly? Right or wrong the gold standard for FDA approval is randomised placebo controlled trial. Yes there are exceptions but the fact the FDA specifically asked for this and MESO went other direction was always a concern for me personally.
the other issue for me (putting tinfoil hat on) is the power and influence of big pharma. Have seen more than a few small bios get whacked by FDA where a larger player would be negatively impacted. But of course - impossible to prove.
hoping for positive news but feels like 2020 all over again. I’ve rarely seen a company sit on positive news past the day of approval notification
Ann: Trading Halt, page-1016
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