with the relevant US agencies getting tossed into the wringer, a little transparency on the cos.' efforts internationally would be helpful.

From the recently posted research article and as highlighted by reddit user waxonwaxoff2920:

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"Additionally, CytoDyn might consider ex-U.S. regulatory strategies: for instance, seeking EMA approval or Conditional Marketing Authorization in Europe if data is compelling. To date, leronlimab has not announced EMA’s PRIME designation or similar, but as the program advances, engaging European regulators could open a parallel path. A factor here is Orphan Drug designation in regions: while U.S. orphan status for TNBC is uncertain, CytoDyn could seek EMA orphan designation for mTNBC if criteria are met, which would give 10 years of EU market exclusivity upon approval.

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