NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

You just reinforced the point. ALL of these companies DID NOT file in the U.S. and are not approved in the U.S. and therefore missing considerable revenue.
FDA has a very high bar for stem cell therapies. No doubt they did review their data with the FDA -- their shareholders would HANG them if they didn't make a run at U.S. approval.

Look at Alofisel -- withdraw when the FDA requested additional data.

It is very common that biotechs apply in more than one country at a time. But if FDA says they don't have adequate data for FDA acceptance, they don't have another choice but to file in EU and other markets. You have just reinforced my point.

Kymriah was FIRST approved in the U.S. -- Kymriah received its first FDA approval in August 2017 for pediatric and young adult B-cell precursor acute lymphoblastic leukemia (ALL). FDA approval makes it easier in most other regulatory bodies as FDA has one of the most rigorous review processes.