Ann: VivaGel BV US FDA Appeal Outcome, page-9

Say goodbye to the US$101m licence fee with EDW Pharma (formerly ITF Pharma).

IMO the chances of another company/partner licencing VivaGel to do an another Phase 3 trial themselves in the US is ZERO.

So the USA (the largest single pharmaceutical market in the world) and FDA remain the boogeymen for Starpharma. None of Starpharma’s 3 commercialised products have got FDA approval. This says a lot and goes to the lack of credibility this company has.

At least CM finally acknowledged in writing that Starpharma did in fact receive a Complete Response Letter from the FDA way back in 2018. Something that astonishingly, previous management could not bring themselves to do.

This year has certainly started off terribly for the new CEO and shareholders and I fear there’s more pain to come in 2024 without AstraZeneca coming to the party.