Rejuvenated Melflufen! I believe THTX will and definitely should try to have their PDC/PDCs approved in the Europe. One has to question how and why the decision making process, approval protocols and requirements differ among authorities but based on the same set of data it seems Oncopeptides can get their prodrug/peptide conjugate approved in the Europe which was initially approved in the US and then withdrawn due to safety issues. It looks like the final regulatory outcome/decision for specifically late stage cancer drugs and for that matter serious unmet conditions(NASH) in various regions can’t be assumed as authorities seems to have different opinions about risks and the rewards for instance in case of NASH we know the difference as EMA requires reduction in fibrosis but FDA stops at not worsening fibrosis. Any way Oncopeptides still has to get EMA on board but it looks promising so far at least in the Europe I guess they are more confident to carry on with their efforts to get the drug back into the US market.
https://www.fiercepharma.com/pharma/rising-ashes-oncopeptides-gains-chmp-endorsement-multiple-myeloma-drug